RESUMEN
Introduction: Platelet concentrates are blood products obtained from donor's blood, and their conservation must be subject to a strict quality control process to guarantee a safe and high-performance product in treating diseases that require their use. Methods: We designed a cross-sectional study to determine the total compliance rate in platelet concentrates obtained in the blood bank of the Cayetano Heredia Hospital in Lima during November and December of 2019. The Buffy method Coat obtained the platelet concentrates, and parameters such as platelet count and residual leukocytes, pH, and swirling effect were evaluated according to the National Hemotherapy and Blood Bank Program criteria. Results: The platelet count had a mean of 6.66 ± 3.94 x 10¹°/µL, the platelet concentrates had a mean of 56.30 ± 6.22 mL, and all, without exception, had the presence of the Swirling phenomenon. The pH had a mean of 7.64 ± 0.15, while the leukocyte count had a mean of 4.22 ± 3.51 x 107/µL. Regarding compliance by the parameters evaluated, it was evident that the platelet and leukocyte count had moderate compliance rates of 43.6% and 24.1%, while the pH and swirling effect had rates of 100% in both cases. The total compliance rate was 54.9% (95% confidence interval: 46.0 to 63.5). Conclusions: The compliance rate of platelet concentrates is moderate, and it is necessary to implement a process of continuous quality improvement in the blood bank.
Introducción: Los concentrados plaquetarios son hemoderivados obtenidos de la sangre, y su conservación debe estar supeditada a un estricto proceso de control de calidad para garantizar un producto inocuo y de alto rendimiento en el tratamiento de enfermedades que requieran su uso. Métodos: Diseñamos un estudio transversal que tuvo por objetivo determinar la tasa de conformidad total en concentrados plaquetarios obtenidos en el banco de sangre del Hospital Cayetano Heredia de Lima durante los meses de noviembre y diciembre del año 2019. Los concentrados plaquetarios fueron obtenidos por el método de Buffy Coat y se evaluaron parámetros como el recuento de plaquetas y leucocitos residuales, pH y efecto swirling, según criterios del Programa Nacional de Hemoterapia y Bancos de Sangre. Resultados: El recuento de plaquetas tuvo una media de 6.66 ± 3.94 x1010/µL y los concentrados plaquetarios tuvieron una media de 56.30 ± 6.22 mL, y todos sin excepción tuvieron presencia de fenómeno Swirling. El pH tuvo una media de 7.64 ± 0.15, mientras que el recuento de leucocitos tuvo una media de 4.22 ± 3.51 x107/µL. En cuanto al cumplimiento por parámetro evaluado, se evidenció que el recuento de plaquetas y leucocitos tuvieron tasas de conformidad de 43.6% y 24.1%, mientras que el pH y efecto swirling tuvieron tasas del 100% en ambos casos. La tasa de conformidad total fue 54.9% (CI95%: 46.0 a 63.5). Conclusiones: La tasa de conformidad de los concentrados plaquetarios es moderada, y se requiere implementar un proceso de mejora continua de la calidad en el banco de sangre.
Asunto(s)
Bancos de Sangre , Plaquetas , Control de Calidad , Humanos , Perú , Estudios Transversales , Recuento de Plaquetas , Bancos de Sangre/normas , Recuento de Leucocitos , Hospitales , Concentración de Iones de Hidrógeno , Transfusión de Plaquetas/normas , Transfusión de Plaquetas/métodosRESUMEN
BACKGROUND AND OBJECTIVES: In Japan, cord blood transplantations exceed those done with adult-sourced unrelated stem cells. This study analyses cord blood (CB) storage criteria to maintain high-quality CB units. MATERIALS AND METHODS: The Kanto-Koshinetsu Cord Blood Bank received 29,795 units from 2014 to 2021, mostly >60 mL, and 5486 (18.4%) were stored as transplantable units. We investigated the mother's gestational period, CB volume, total nucleated cells (TNCs), CD34+ cells, total colony-forming units (CFUs), time from collection to reception and cryopreservation, cell viability, and the reasons for not storing a unit. RESULTS: The average time from collection to reception of 29,795 units was 18.0 h. The most common reason for not storing a CB unit was low cell numbers (pre-processing TNC count <1.2 billion), accounting for 67.9% of the units received. There was no correlation between the CB volume and the CD34+ cell count. The shorter the gestational period, the lower the TNC count, but the higher the CD34+ cell count. There was no correlation between the time from collection to cryopreservation, within a 36-h time limit, and the CD34+ cell recovery rate. CONCLUSION: We could accept units with a TNC count <1.2 billion and a CB volume <60 mL from a gestational period of 38 weeks or less if we did a pre-processing CD34+ cell count. This would secure more units rich in CD34+ cells.
Asunto(s)
Bancos de Sangre , Conservación de la Sangre , Criopreservación , Sangre Fetal , Humanos , Sangre Fetal/citología , Japón , Bancos de Sangre/normas , Conservación de la Sangre/métodos , Femenino , Trasplante de Células Madre de Sangre del Cordón Umbilical , Antígenos CD34 , Embarazo , MasculinoRESUMEN
BACKGROUND: Blood banks are an important part of healthcare systems. They embrace critical processes that start with donor recruitment and blood collection, followed by blood processing to produce different types of blood components used in transfusions, blood storage, blood distribution, and transfusion. Blood components must be generated at high quality, preserved safely, and transfused in a timely manner. This can be achieved by operating interrelated processes within a complex network. There is no comprehensive blueprint of Blood Banking and Transfusion (BB&T) processes and their relationships; therefore, this study aims to develop and evaluate a BB&T process architecture using the Riva method. RESEARCH DESIGN: This research adopts a design science research methodology process (DSRM) that aims to create artifacts for the purpose of serving humanity through six phases: identifying problems, identifying solutions and objectives, designing and developing artifacts, demonstrating and evaluating the artifacts, and communicating the work. The adapted DSRM process is used to build a process architecture in the BB&T unit to improve the quality and strategic planning of BB&T processes. Applying the adapted DSRM process generated four increments before the outcomes were communicated as a highly comprehensive BB&T process architecture (BB&TPA) blueprint for virtual organizations. Finally, the generated BB&TPA is tested and validated at a reference hospital. RESULTS: A Riva-based process architecture diagram was successfully developed, acting as a reference model for virtual BB&T organizations. It is a novel output in the domain of BB&T and can also be considered as a reference model to evaluate the existing processes in BB&T real-world units. This assists domain experts in performing gap analysis in their BB&T units and paths for developing BB&T management information systems and can be incorporated in the inspection workflow of accreditation organizations.
Asunto(s)
Bancos de Sangre , Transfusión Sanguínea , Humanos , Bancos de Sangre/normas , Transfusión Sanguínea/métodosRESUMEN
INTRODUCTION: Platelet concentrates are blood products obtained from donor's blood, and their conservation must be subject to a strict quality control process to guarantee a safe and high-performance product in treating diseases that require their use. METHODS: We designed a cross-sectional study to determine the total compliance rate in platelet concentrates obtained in the blood bank of the Cayetano Heredia Hospital in Lima during November and December of 2019. The Buffy method Coat obtained the platelet concentrates, and parameters such as platelet count and residual leukocytes, pH, and swirling effect were evaluated according to the National Hemotherapy and Blood Bank Program criteria. RESULTS: The platelet count had a mean of 6.66 ± 3.94 x 10¹°/µL, the platelet concentrates had a mean of 56.30 ± 6.22 mL, and all, without exception, had the presence of the Swirling phenomenon. The pH had a mean of 7.64 ± 0.15, while the leukocyte count had a mean of 4.22 ± 3.51 x 107/µL. Regarding compliance by the parameters evaluated, it was evident that the platelet and leukocyte count had moderate compliance rates of 43.6% and 24.1%, while the pH and swirling effect had rates of 100% in both cases. The total compliance rate was 54.9% (95% confidence interval: 46.0 to 63.5). CONCLUSIONS: The compliance rate of platelet concentrates is moderate, and it is necessary to implement a process of continuous quality improvement in the blood bank.
INTRODUCCIÓN: Los concentrados plaquetarios son hemoderivados obtenidos de la sangre, y su conservación debe estar supeditada a un estricto proceso de control de calidad para garantizar un producto inocuo y de alto rendimiento en el tratamiento de enfermedades que requieran su uso. MÉTODOS: Diseñamos un estudio transversal que tuvo por objetivo determinar la tasa de conformidad total en concentrados plaquetarios obtenidos en el banco de sangre del Hospital Cayetano Heredia de Lima durante los meses de noviembre y diciembre del año 2019. Los concentrados plaquetarios fueron obtenidos por el método de Buffy Coat y se evaluaron parámetros como el recuento de plaquetas y leucocitos residuales, pH y efecto swirling, según criterios del Programa Nacional de Hemoterapia y Bancos de Sangre. RESULTADOS: El recuento de plaquetas tuvo una media de 6.66 ± 3.94 x1010/µL y los concentrados plaquetarios tuvieron una media de 56.30 ± 6.22 mL, y todos sin excepción tuvieron presencia de fenómeno Swirling. El pH tuvo una media de 7.64 ± 0.15, mientras que el recuento de leucocitos tuvo una media de 4.22 ± 3.51 x107/µL. En cuanto al cumplimiento por parámetro evaluado, se evidenció que el recuento de plaquetas y leucocitos tuvieron tasas de conformidad de 43.6% y 24.1%, mientras que el pH y efecto swirling tuvieron tasas del 100% en ambos casos. La tasa de conformidad total fue 54.9% (CI95%: 46.0 a 63.5). CONCLUSIONES: La tasa de conformidad de los concentrados plaquetarios es moderada, y se requiere implementar un proceso de mejora continua de la calidad en el banco de sangre.
Asunto(s)
Humanos , Control de Calidad , Bancos de Sangre/normas , Plaquetas , Perú , Recuento de Plaquetas , Estudios Transversales , Transfusión de Plaquetas/métodos , Transfusión de Plaquetas/normas , Hospitales , Concentración de Iones de Hidrógeno , Recuento de LeucocitosRESUMEN
BACKGROUND: Current hemovigilance methods generally rely on survey data or administrative claims data utilizing billing and revenue codes, each of which has limitations. We used electronic health records (EHR) linked to blood bank data to comprehensively characterize red blood cell (RBC) utilization patterns and trends in three healthcare systems participating in the U.S. Food and Drug Administration Center for Biologics Evaluation and Research Biologics Effectiveness and Safety (BEST) initiative. METHODS: We used Information Standard for Blood and Transplant (ISBT) 128 codes linked to EHR from three healthcare systems data sources to identify and quantify RBC-transfused individuals, RBC transfusion episodes, transfused RBC units, and processing methods per year during 2012-2018. RESULTS: There were 577,822 RBC units transfused among 112,705 patients comprising 345,373 transfusion episodes between 2012 and 2018. Utilization in terms of RBC units and patients increased slightly in one and decreased slightly in the other two healthcare facilities. About 90% of RBC-transfused patients had 1 (~46%) or 2-5 (~42%)transfusion episodes in 2018. Among the small proportion of patients with ≥12 transfusion episodes per year, approximately 60% of episodes included only one RBC unit. All facilities used leukocyte-reduced RBCs during the study period whereas irradiated RBC utilization patterns differed across facilities. DISCUSSION: ISBT 128 codes and EHRs were used to observe patterns of RBC transfusion and modification methods at the unit level and patient level in three healthcare systems participating in the BEST initiative. This study shows that the ISBT 128 coding system in an EHR environment provides a feasible source for hemovigilance activities.
Asunto(s)
Registros Electrónicos de Salud , Transfusión de Eritrocitos , Humanos , Femenino , Masculino , Persona de Mediana Edad , Adulto , Estados Unidos , Eritrocitos , Anciano , Productos Biológicos/uso terapéutico , Bancos de Sangre/normas , Bancos de Sangre/estadística & datos numéricos , AdolescenteRESUMEN
BACKGROUND: Blood components are costly and scarce. The Blood Stocks Management Scheme (BSMS) was established in the United Kingdom (UK) to support hospital transfusion services and national blood services through collection, analysis, and monthly feedback of data on blood component inventory and wastage management. There is a growing evidence base on how best to deliver feedback for quality improvement. We assessed the quality and utility of the monthly BSMS component reports. METHODS: We assessed the content of BSMS reports issued in March 2023 against established criteria for effective feedback. Two researchers independently rated whether criteria spanning the five domains of goal setting, data collection, feedback content, feedback display and feedback delivery were fully, partially or not met. Disagreements were resolved through discussion. We conducted an online questionnaire survey of recipients of BSMS reports during March 2023 to assess their use of reports and seek suggestions for improvement. RESULTS: Five out of 20 criteria for effective feedback were fully met. Areas for improvement included placing more emphasis in the feedback on positive change, linking data and summary messages, and including specific suggestions for action. Respondents highlighted the value of benchmarked comparisons with other hospital transfusion services. CONCLUSION: There is scope for enhancing the effectiveness and utility of BSMS feedback reports and hence reducing wastage of blood components. This methodology for evaluation of feedback could be utilized to improve other areas of transfusion practice.
Asunto(s)
Transfusión de Componentes Sanguíneos , Humanos , Reino Unido , Encuestas y Cuestionarios , Retroalimentación , Bancos de Sangre/normas , Mejoramiento de la Calidad , Transfusión Sanguínea/normasRESUMEN
The walking blood bank (WBB) is a system for emergency blood acquisition from nearby donors if a patient's blood needs exceed the immediate supply. USCENTCOM medical units will perform a walking blood bank if immediate blood requirements exceed the local supply. A benchmark WBB performance time was needed to provide a training goal for military WBB exercises. An expeditionary WBB performance time benchmark was created from prospective measurements of USCENTCOM medical unit performance times over 9 months. The mean total time, and new performance benchmark, for a WBB in USCENTCOM was 41.4 min +/- 13.2 min. USCENTCOM time from donor arrival to a transfusable unit mean time was 34.4 +/- 12.1 min. Expeditionary medical units conducting a WBB should expect to meet or exceed the provided benchmark.
Asunto(s)
Benchmarking , Bancos de Sangre , Humanos , Bancos de Sangre/normas , Sistema del Grupo Sanguíneo ABO , Factores de Tiempo , Estudios Prospectivos , Donantes de SangreRESUMEN
In expeditionary environments, the consistent availability of blood for casualty care is imperative yet challenging. Responding to evidence and the specific needs of its expeditionary context, the US Central Command (USCENTCOM) prioritized supplying stored low titer O whole blood (LTOWB) to its units from March, 2023 onward. A strategy was devised to set minimal LTOWB on-hand supply benchmarks, determined by the number of operating beds and point of injury teams. This transition led to a 54% reduction in orders for packed red blood cells. As a countermove, the Armed Services Blood Program (ASBP) enhanced LTOWB production at a conversion rate 2:1 from packed red blood cell to LTOWB. Consequently, there was a decline in expired blood products, and fulfillment rates for blood requests are projected to reach 100% consistently. This paper delves into the intricacies of the expeditionary blood supply, the rationale behind the LTOWB transition, the devised allocation strategy, and the subsequent impacts of this change.
Asunto(s)
Personal Militar , Humanos , Estados Unidos , Personal Militar/estadística & datos numéricos , Transfusión Sanguínea/estadística & datos numéricos , Transfusión Sanguínea/métodos , Transfusión Sanguínea/tendencias , Transfusión Sanguínea/normas , Bancos de Sangre/estadística & datos numéricos , Bancos de Sangre/normas , Bancos de Sangre/provisión & distribución , Medicina Militar/métodos , Medicina Militar/estadística & datos numéricos , Medicina Militar/tendenciasRESUMEN
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.
Asunto(s)
Bancos de Sangre , Sangre Fetal , United States Food and Drug Administration , Infección por el Virus Zika , Humanos , Estados Unidos , Infección por el Virus Zika/transmisión , Sangre Fetal/virología , Bancos de Sangre/normas , Virus Zika , Estudios Retrospectivos , Femenino , MasculinoRESUMEN
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?
Asunto(s)
Bancos de Sangre/normas , Transfusión Sanguínea , Enfermedades de Transmisión Sexual/prevención & control , Enfermedades de Transmisión Sexual/transmisiónRESUMEN
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.
Asunto(s)
Bancos de Sangre/organización & administración , Seguridad de la Sangre/normas , Transfusión Sanguínea/normas , Bancos de Sangre/normas , Hospitales , Humanos , Control de Calidad , Encuestas y Cuestionarios , Estados UnidosAsunto(s)
Bancos de Sangre/normas , Donantes de Sangre , Seguridad de la Sangre/normas , Vacunas contra la COVID-19 , COVID-19/prevención & control , Selección de Donante/normas , Guías de Práctica Clínica como Asunto , SARS-CoV-2 , Adolescente , Adulto , COVID-19/epidemiología , COVID-19/transmisión , Vacunas contra la COVID-19/administración & dosificación , Femenino , Humanos , Programas de Inmunización , Esquemas de Inmunización , Inmunización Secundaria , India , Masculino , Persona de Mediana Edad , Factores de Tiempo , Vacunación , Cobertura de Vacunación , Vacunas Atenuadas , Vacunas de Productos Inactivados , Adulto JovenRESUMEN
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.
Asunto(s)
Bancos de Sangre/normas , Consenso , Transfusión de Eritrocitos/normas , Neoplasias del Cuello Uterino/radioterapia , Transfusión Sanguínea/normas , Femenino , Humanos , Guías de Práctica Clínica como Asunto , Neoplasias del Cuello Uterino/terapiaRESUMEN
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).
Asunto(s)
Almacenamiento de Sangre , Bancos de Sangre , Conocimientos, Actitudes y Práctica en Salud , Personal de Laboratorio Clínico/educación , Medicina Transfusional/educación , Adulto , África/epidemiología , Bancos de Sangre/normas , Recolección de Muestras de Sangre/métodos , Recolección de Muestras de Sangre/normas , COVID-19/sangre , COVID-19/epidemiología , COVID-19/prevención & control , Estudios Transversales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , SARS-CoV-2 , Encuestas y Cuestionarios , Medicina Transfusional/normas , Almacenamiento de Sangre/métodosRESUMEN
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.
Asunto(s)
Donantes de Sangre/provisión & distribución , COVID-19 , Selección de Donante , Adolescente , Adulto , Publicidad , Bancos de Sangre/organización & administración , Bancos de Sangre/normas , Bancos de Sangre/estadística & datos numéricos , Donantes de Sangre/psicología , Donantes de Sangre/estadística & datos numéricos , Seguridad de la Sangre/métodos , Seguridad de la Sangre/estadística & datos numéricos , COVID-19/sangre , COVID-19/epidemiología , COVID-19/patología , COVID-19/prevención & control , Selección de Donante/métodos , Selección de Donante/organización & administración , Selección de Donante/estadística & datos numéricos , Femenino , Humanos , Masculino , Registros Médicos/normas , Persona de Mediana Edad , Motivación , Países Bajos/epidemiología , Periódicos como Asunto , Pandemias , Factores de Riesgo , SARS-CoV-2/fisiología , Índice de Severidad de la Enfermedad , Medios de Comunicación Sociales , Adulto JovenAsunto(s)
Bancos de Sangre/estadística & datos numéricos , Sistemas de Información en Laboratorio Clínico/instrumentación , Procesamiento Automatizado de Datos/métodos , Intercambio de Información en Salud/normas , Bancos de Sangre/normas , Procesamiento Automatizado de Datos/normas , Humanos , Etiquetado de Productos/instrumentación , Estándares de ReferenciaRESUMEN
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, Pâ =â .03). There was no difference in TAT between patients who died and those who were ultimately discharged (60 vs 70, Pâ =â .22). TAT was shortest for orders originating in the emergency department (ED) compared with other locations (64 vs 85, Pâ <â .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 (Pâ =â .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.
Asunto(s)
Almacenamiento de Sangre , Bancos de Sangre , Factores de Coagulación Sanguínea/uso terapéutico , Hemorragia/tratamiento farmacológico , Patología Clínica/métodos , Bancos de Sangre/normas , Humanos , Centros de Atención Terciaria/normas , Almacenamiento de Sangre/métodosRESUMEN
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.
Asunto(s)
Bancos de Sangre , Tratamiento Basado en Trasplante de Células y Tejidos/tendencias , Sangre Fetal , Acreditación/normas , Automatización , Bancos de Sangre/economía , Bancos de Sangre/legislación & jurisprudencia , Bancos de Sangre/organización & administración , Bancos de Sangre/normas , Conservación de la Sangre/métodos , Tratamiento Basado en Trasplante de Células y Tejidos/economía , Tratamiento Basado en Trasplante de Células y Tejidos/métodos , Ensayo de Unidades Formadoras de Colonias , Trasplante de Células Madre de Sangre del Cordón Umbilical , Criopreservación/métodos , Europa (Continente) , Femenino , Sangre Fetal/citología , Prueba de Histocompatibilidad , Humanos , Inmunoterapia Adoptiva/métodos , Células Madre Pluripotentes Inducidas/citología , Recién Nacido , Consentimiento Informado , Embarazo , Complicaciones Infecciosas del Embarazo/diagnóstico , Garantía de la Calidad de Atención de Salud , Medicina Regenerativa/métodos , Manejo de Especímenes/instrumentación , Manejo de Especímenes/métodos , Donantes de Tejidos , Obtención de Tejidos y Órganos/métodos , Obtención de Tejidos y Órganos/organización & administración , Obtención de Tejidos y Órganos/normas , Estados Unidos , United States Food and Drug AdministrationRESUMEN
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.