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1.
Tunis Med ; 102(7): 415-418, 2024 Jul 05.
Article in French | MEDLINE | ID: mdl-38982966

ABSTRACT

INTRODUCTION: Transfusion is an important question of daily clinical practice. Transfusion is governed by rigorous security rules. AIM: To assess the knowledge of healthcare personnel regarding transfusion. METHODS: This descriptive study was carried out by an anonymous survey, with anaesthetist resident, surgery resident, interns, anaesthetist, and nurses. This study was from January 1 to February 29, 2020. It was approved by the local ethics committee. RESULTS: We included 196 participants. 94.9% knew that red blood cells must be stored in the refrigerator. 58.2% thought that red blood cells should be transfused within 30 minutes of warming, and 31.6% said it should be transfused within 3 hours. We found that 85% knew that fresh frozen plasma should be stored in the freeze, and 59.7% said that the frozen plasma should be thawed within 30 minutes at most and 38.3% thought that the thawing should take at least one hour. Regarding the pretransfusion bedside test, 84.4% knew that it must be done by two personnel one of whom must be a doctor. 40.8% thought that the test consists of mix a drop of patient blood and a drop of bag blood. CONCLUSION: Several insufficiencies were found. There is a necessity of launching periodic training courses focusing on the management of blood products and the transfusion procedure.


Subject(s)
Blood Transfusion , Health Knowledge, Attitudes, Practice , Health Personnel , Humans , Blood Transfusion/standards , Blood Transfusion/statistics & numerical data , Health Personnel/education , Surveys and Questionnaires , Female , Male , Adult , Clinical Competence/standards
4.
Transfus Apher Sci ; 63(3): 103916, 2024 Jun.
Article in English | MEDLINE | ID: mdl-38553365

ABSTRACT

BACKGROUND AND OBJECTIVES: Transfusion safety may be becoming dependent on the financial resources made available for transfusion structures and may vary between high-income countries (HIC) and low-to-middle-income countries (LMIC). To assess whether there is a difference in the reported TR between these two groups of countries, we examined TR reported in Tunis the capital of Tunisia, a LMIC, and compared their frequency with reported TR in HIC. MATERIALS AND METHODS: Data of TR were collected from transfusion incident report (TIR) forms declared by healthcare facilities in Tunis between 2015 and 2019. They were analysed and compared to reported TR in France (ANSM) and UK (SHOT). RESULTS: The incidence of TR was 70.6/100 000 blood components (BP) issued. A third of TR (36.8%) occurred at night. Febrile non-hemolytic transfusion reactions (43.7%) and allergic reactions (35%) were the most reported TR respectively 22.4/100 000 BP and 17.9/100 000 BP. The rate of ABO incompatibilities was 1.96/100 000 red blood cell units (RBC): they were all caused by human error. The rates of TRALI, TACO and bacterial contaminations were respectively 1.26/100 000 BP, 1.4/100 000 RBC and 0.7/100 000 BP. CONCLUSION: While advanced technologies applied to transfusion have improved transfusion safety, this study shows that their impact has been relatively minor, as reported TR in LMIC are still comparable to those in HIC. ABO-incompatibilities are still higher in LMIC: this should be addressed by reinforcing the training of all healthcare personnel involved in transfusion medicine.


Subject(s)
Developed Countries , Developing Countries , Humans , Transfusion Reaction/epidemiology , Blood Safety , Blood Transfusion/methods , Female , Male , Tunisia
5.
Transfusion ; 64(4): 627-637, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38476028

ABSTRACT

BACKGROUND: Transfusion-related errors are largely preventable but may lead to blood product wastage and adverse reactions, resulting in patient harm. In the United States, the incidence of transfusion-related errors is poorly understood nationally. We used data from the National Healthcare Safety Network (NHSN) Hemovigilance Module to describe and quantify transfusion-related errors, as well as associated transfusion-related adverse reactions and blood product wastage. METHODS: During 2014-2022, data from the NHSN Hemovigilance Module were used to analyze errors, including near misses (errors with no transfusion), incidents (errors with transfusion), and associated serious adverse reactions (severe, life-threatening, or death). RESULTS: During 2014-2022, 80 acute care facilities (75 adult; 5 pediatric) reported 63,900 errors. Most errors occurred during patient blood sample collection (21,761, 34.1%) and blood sample handling (16,277, 25.5%). Less than one-fifth of reported errors (9822, 15.4%) had a completed incident form. Of those, 8780 (89.3%) were near misses and 1042 (10.7%) incidents. More than a third of near misses (3363, 38.3%) were associated with a discarded blood product, resulting in 4862 discarded components. Overall, 87 adverse reactions were associated with errors; six (7%) were serious. CONCLUSIONS: Over half of the transfusion-related errors reported to the Hemovigilance Module occurred during blood sample collection or sample handling. Some serious adverse reactions identified were associated with errors, suggesting that additional safety interventions may be beneficial. Increased participation in the Hemovigilance Module could enhance generalizability and further inform policy development regarding error prevention.


Subject(s)
Blood Safety , Transfusion Reaction , Humans , Child , Transfusion Reaction/epidemiology , Transfusion Reaction/etiology , Blood Transfusion , Blood Banks , Delivery of Health Care
6.
Transfusion ; 64(4): 590-596, 2024 Apr.
Article in English | MEDLINE | ID: mdl-38400777

ABSTRACT

BACKGROUND: Correct classification of transfusion reactions is important not only for effective patient care and donor management but also for accurate tracking of events in hemovigilance systems. We compared the ability of a generative artificial intelligence (AI) system to correctly diagnose hypothetical clinical situations as transfusion reactions in comparison to previous studies reporting the accuracy of transfusion medicine (TM) specialists in assessing these cases. METHODS: An AI system was requested to assess 36 case scenarios to provide a diagnosis, severity, and imputability of the transfusion reactions using the CDC National Healthcare Safety Network (NHSN) criteria. Responses were compared to an expert panel's classifications and to the published responses of a panel of TM specialists. Additionally, the AI's responses were compared to the TM specialists' prior attempts to use the TrDDx web-based algorithm for the five most challenging cases. RESULTS: The AI's classification accuracy varied widely depending on the NHSN category. The AI accurately classified all transfusion-associated circulatory overload and transfusion-related acute lung injury cases, exceeding TM specialists' assessments. Conversely, it did not correctly identify any cases in select NHSN categories such as DSTR. Overall accuracy among all diagnostic categories was 48.7% for AI responses versus 72.1% for prior TM specialist responses (p = 0.005). AI-generated responses included non-standard terminology, limited severity assessments, and no imputability determinations. DISCUSSION: A generative AI system may have a role in helping healthcare providers to consider transfusion reaction categories that might be missed, but caution is advised in applying the AI's output to transfusion reaction classification at present.


Subject(s)
Artificial Intelligence , Transfusion Reaction , Humans , Algorithms , Health Facilities , Health Personnel
7.
Transfus Clin Biol ; 31(2): 62-69, 2024 May.
Article in English | MEDLINE | ID: mdl-38199317

ABSTRACT

Despite their use in life-saving treatment, blood and blood products can cause life-threatening complications. To administer blood transfusion safely, national guidelines and protocols should be consulted in healthcare organizations. In Türkiye, there are guides and regulations published by the Ministry of Health. With the definition of hemovigilance in the regulations; training in clinical use of blood and transfusion practice fields is now mandatory. This study presents data from a survey designed to assess transfusion knowledge levels of clinical departments for the purpose of planning our training programs. A two-part survey was conducted on 110 nurses from various departments. Questions included sociodemographic attributes, department they worked in, employment duration, knowledge level on transfusion practices. Statistical analysis was performed. Of the nurses that participated; 52.7% were above 40 years old, 15.5% were 31-40 years old and 31.8% were below 30 years old. For education; 84.5% of the nurses were graduates or postgraduates. For work experience; 64.5% were working in internal medicine departments, 58.2% had been working as a nurse for 10 or more years while 85.5% worked in the same department for less than 5 years. It was determined that the nurses should know more about transfusion. Beginner nurses in the intense care unit were found to have lower levels of transfusion practice knowledge, from this it was deduced additional training should be scheduled for beginner nurses with low transfusion knowledge. In addition to theoretical instructions, one-on-one training on operation controls and "observation and guidance" style practical training should be implemented. Theoretical and practical topics with inadequate knowledge should be instructed in finer detail to increase the knowledge level in these subjects.


Subject(s)
Blood Transfusion , Nurses , Humans , Adult , Surveys and Questionnaires , Hospitals , Health Knowledge, Attitudes, Practice , Clinical Competence
8.
Lab Med ; 55(3): 251-254, 2024 May 02.
Article in English | MEDLINE | ID: mdl-38175635

ABSTRACT

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.


Subject(s)
Cost Savings , Platelet Transfusion , Humans , Platelet Transfusion/adverse effects , Platelet Transfusion/methods , Platelet Transfusion/economics , Male , Female , Middle Aged , Transfusion Reaction/prevention & control , Aged , Blood Safety/methods , Blood Safety/economics , Adult , Leukocyte Reduction Procedures/methods
9.
Transfusion ; 64(2): 200-209, 2024 02.
Article in English | MEDLINE | ID: mdl-38158876

ABSTRACT

BACKGROUND: Use of the National Healthcare Safety Network (NHSN) has been essential to the success of the Massachusetts Hemovigilance Program and has allowed for the timely identification of signals and trends over a defined population that correlate with national and international hemovigilance (HV) data. Here, we outline how the NHSN system is used for monitoring HV data in Massachusetts and encourage adoption of NHSN for nationwide HV surveillance. STUDY DESIGN AND METHODS: A collaboration that grew over time between local HV stakeholders and the Massachusetts Department of Public Health (MDPH) resulted in the change from a paper-based method of reporting adverse reactions and monthly transfusion activity for compliance with state requirements to replacement with statewide adoption of reporting via NHSN. RESULTS: Over 1.5 million blood products were transfused in Massachusetts between 2017 and 2021, with 3000 adverse reactions among 10 defined types reported. Using NHSN, MDPH has been able to produce numerous reports, publications, and presentations that have made previously non-obtainable HV and blood utilization data available. DISCUSSION: Although limitations to these self-reported data exist, such as lack of external validation, successful statewide implementation of NHSN for hospital blood bank reporting is possible and has benefits beyond those for regulatory oversight. It results in standardized, actionable data at both the hospital and state level, enabling inter-facility comparisons, benchmarking, and opportunities for practice improvement.


Subject(s)
Blood Safety , Blood Transfusion , Humans , Blood Banks , Massachusetts , Delivery of Health Care
10.
BMC Health Serv Res ; 23(1): 1169, 2023 Oct 27.
Article in English | MEDLINE | ID: mdl-37891622

ABSTRACT

BACKGROUND AND PURPOSE: Hemovigilance is a set of monitoring methods that covers the blood transfusion chain, from collecting blood and blood products to monitoring the blood recipients. To this end, any error in this process can have serious and irreparable consequences for patients. The present study aimed to investigate the quality of hemovigilance process in Iran, using the first two steps of Six Sigma model. METHODS: This was a quantitative cross-sectional study that was conducted over 6 months (from August 20, 2021, to February 20, 2022) at Afzalipour Hospital in Iran, using the first two steps of Six Sigma model. The study population comprised of all inpatients who needed blood or blood product transfusion in various departments of Afzalipour Hospital, among whom 477 patients were selected via stratified sampling in three shifts (morning, evening, and night). The datasheet was used to record errors in the three shifts. This research was conducted, using the DMAIC cycle's "define" and "measure" steps. RESULTS: In the define step, the hemovigilance process at Afzalipour Hospital was divided into two categories of normal process and emergency process. Each of these processes consists of several sub-processes, including "phlebotomy," "requesting blood and blood products from the department," "preparation of application by the blood bank," " sending a request from the blood bank to the blood transfusion center," "transfusing blood and blood products," and "returning the blood and blood products to the blood bank and waste disposal." In the measure step, the quality of hemovigilance process was evaluated based on sub-processes and labels at morning, evening and night shifts. The sub-process of sending a request from the blood bank to the blood transfusion center had the highest error rate with a sigma level of 1.5. Also, the evening and night shifts had a sigma level of 1.875, and the clinical and registration labels had a sigma level of 1.875. The overall sigma level of hemovigilance process was calculated to be 2. CONCLUSION: The results of this study showed that the quality of hemovigilance process at Afzalipour Hospital was poor. By employing the first two steps of Six Sigma method, we identified the existing errors in the hemovigilance process of Afzalipour hospital in order to assist hospital managers to take the necessary measures to improve this process.


Subject(s)
Blood Safety , Total Quality Management , Humans , Cross-Sectional Studies , Blood Transfusion , Blood Banks
11.
J Blood Med ; 14: 435-443, 2023.
Article in English | MEDLINE | ID: mdl-37576590

ABSTRACT

Introduction: Reporting of transfusion reactions is good practice and required by many guidelines. Errors in the transfusion chain can also lead to severe patient reactions and depend on active error reporting. We aimed to characterize transfusion incidents and asked whether workup of transfusion reactions may also contribute to revealing logistical errors. Methods: Transfusion medical records from 2011 to 2019 at our tertiary medical centre, as well as forensic autopsy reports, digitized sections, and court records from 1990 to 2019 were analysed. A total of 230,845 components were transfused between 2011 and 2019 at our own institution. Results: Overall, 322 transfusion incidents were reported. Of these, 279 were from our own institution, corresponding to a frequency of 0.12% of all transfusions. The distribution of reaction types is consistent with the literature, with allergic reactions (55.9%), febrile-non-hemolytic reactions (FNHTR, 24.2%), hemolytic reactions (3.4%) and other types at smaller frequencies (<3%). Twenty-nine (10.4%) of the 279 reports revealed logistical errors, including hemoglobin above guideline threshold (4.3%), incorrect or non-performed bedside tests (3.2%), inadequate patient identification (2.5%), laboratory and issuing errors, missed product checks or failure to follow recommendations (1.1% each). Eight of 29 (27.5%) of the logistical errors were detected by serendipity during workup of incident reports. In addition, 8/932 autopsy cases under code A14 (medical treatment errors) were found to be transfusion-associated (0.9%). Conclusion: Systematic workup of transfusion incidents can identify previously undetected errors in the transfusion chain. Passive reporting of errors through the recording of side effects may serve as a tool to assess more closely assess the frequency and quality of handling errors in real life, and thus serve to improve patient safety.

12.
Bol. venez. infectol ; 34(1): 15-25, ene-jun 2023.
Article in Spanish | LILACS-Express | LILACS | ID: biblio-1512774

ABSTRACT

Introducción: La infección transmitida por transfusión (ITT) es producto de la inoculación directa de un agente infeccioso específico desde la unidad de sangre al huésped susceptible. Los marcadores serológicos positivos responden a características epidemiológicas no detectadas en miembros de la población aparentemente saludable. Objetivo general: Determinar la prevalencia de marcadores infecciosos y las características sociodemográficas en unidades sanguíneas procesadas de donantes que asisten al banco de sangre del Complejo Hospitalario Universitario "Ruíz y Páez" de Ciudad Bolívar - Estado Bolívar, período junio 2019 - junio 2022. Metodología: Se trató de un estudio de tipo descriptivo, retrospectivo, no experimental. El universo estuvo conformado por 13 016 unidades sanguíneas, 414 muestras fueron reactivas, que reportaron un total de 434 serologías positivas. Resultados: Se apreció una prevalencia global de 3,34 % para cualquier ITT; el marcador infeccioso más frecuente fue sífilis con el 60,83 % y una prevalencia de 2,03 %. Tomando en cuenta las características sociodemográficas predominantes: género masculino, 65,94 %; grupo etario 38-47 años, 28,74 %; ocupación obrera, 24,88 %; provenientes de Ciudad Bolívar, 84,06 %. Las muestras con coinfección representaron un 4,58 %, siendo la combinación VIH+Sífilis la más frecuente 1,45 %. El año 2021 destacó con 35,25 % serologías positivas. Conclusiones: La prevalencia de marcadores infecciosos se considera no despreciable. Se debe reforzar la prevención y cura de las enfermedades infecciosas trasmisibles en miembros de la población aparentemente saludable, así como también redirigir las estrategias en el manejo de seguridad transfusional.


Introduction: Transfusion-transmitted infection (ITT) is the direct inoculation of a specific infectious agent from the blood unit to the susceptible host. Positive serological markers respond to epidemiological characteristics not detected in members of the apparently healthy population. General objective: Determine the prevalence of infection markers and sociodemographic characteristics in processed blood units of donors attending the blood bank of the "Ruíz y Páez" University Hospital Complex in Ciudad Bolívar - Bolivar State, period June 2019 - June 2022. Methodology: This was a descriptive, retrospective, nonexperimental study. The universe consisted of 13 016 blood units, 414 samples were reactive, which reported a total of 434 positive serologies. Results: An overall prevalence of 3.34 % was found for any ITT; the most frequent infection markers were syphilis with 60.83% and a prevalence of 2.03 %. Taking into account the predominant sociodemographic characteristics: male gender, 65.94 %; age group 38-47 years, 28.74 %; labor occupation, 24.88 %; from Ciudad Bolivar, 84.06 %. The samples with coinfection represented 4.58 %, being the combination HIV+Syphilis the most frequent 1.45 %. Year 2021 stood out with 35.25 % positive serologies. Conclusions: The prevalence of infection markers is considered not negligible. The prevention and cure of communicable infectious diseases in members of the apparently healthy population should be strengthened, as well as redirecting strategies in transfusion safety management.

13.
J Blood Med ; 14: 337-343, 2023.
Article in English | MEDLINE | ID: mdl-37163174

ABSTRACT

Purpose: In Norway, blood donors using antihypertensive medication were deferred until 2015. Following revision of the national directive, these donors could be allowed, providing stable dose for at least 3 months, adequate blood pressure control and no adverse effects caused by the therapy. The new practice was evaluated by a quality study where the major aim was to establish whether donations from blood donors on antihypertensive medication pose a risk to the donor. The risk was assessed by counting the number and categorizing the adverse events related to blood donation. In addition, the quantitative effect of including these donors was calculated. Subjects and Methods: In this retrospective quality study, blood donors on antihypertensive therapy were recruited from four different blood centers to fill out a questionnaire. A total of 265 donors answered questions regarding their health status, type of medication used, and adverse events connected to blood donation both before and after starting the therapy. Results: No severe adverse events were observed in donors on antihypertensive medications. The amount of mild adverse events, as exhibited by only 7 persons (0.46%) in this donor population, was the same as for donors without hypertensive treatment. Conclusion: Blood donation from persons on antihypertensive therapy poses no extra risk of severe adverse events, given the use of screening criteria to identify and bleed only low-risk donors.

14.
Transfus Med Hemother ; 50(2): 123-128, 2023 Apr.
Article in English | MEDLINE | ID: mdl-37066057

ABSTRACT

Background: Assuring the quality and safety of blood and blood components is an essential element of health care in all countries and requires government commitment and legal frameworks. Ineffective regulation of blood and blood components has far-reaching consequences that are not limited to the affected countries but also have extensive global implications. Summary: In this review, we summarize the work of the project BloodTrain funded by the German Ministry of Health within the framework of the Global Health Protection Programme to strengthen regulatory structures in Africa that are imperative to guarantee the improved availability, safety, and quality of blood and blood products. Key Messages: Intense interaction with the stakeholders in African partner countries lead to first measurable successes in the strengthening of blood regulation, as shown here for hemovigilance.

15.
Transfus Med Hemother ; 50(2): 144-153, 2023 Apr.
Article in English | MEDLINE | ID: mdl-37066059

ABSTRACT

Introduction: Following the first assessment of the effects of safety measures taken against transfusion-transmitted bacterial infections (TTBI), the Paul-Ehrlich-Institut (PEI) decided to newly analyze risk minimization measures (RMM) using German hemovigilance data from 2011 to 2020, focusing on blood components, recipients, and bacterial strains. Materials and Methods: The PEI assessed the imputability of all reported serious adverse reactions (SAR) relying mainly on microbiological test results. Reporting rates (RR) of suspected, confirmed, and fatal confirmed TTBI were calculated and compared to the previous reporting 10-year period (2001-2010) using Poisson regression to estimate RR ratios (RRR). Furthermore, details on blood component age, patients' medical history, and bacterial pathogenicity were collected. Results: With respect to the previous 10-year period, the number of suspected TTBI increased (n = 403), while fewer cases were confirmed (n = 40); the number of deaths remained more or less unchanged (n = 8). The RR for suspected TTBI were 7.9, 18.7, and 1.6 cases per million units transfused for red blood cells (RBC), platelet concentrates (PC), and fresh frozen plasma (FFP), respectively. RRR showed a statistically significant 2.5-fold increase in the RR for suspected TTBI after RBC administration from 2001-2010 to the period under review (p < 0.0001). The RR for confirmed TTBI were 0.4, 5.0, and 0.0 cases per million units transfused for RBC, PC, and FFP, respectively. Compared to the period 2001-2010, there was a statistically significant decrease in the RR of confirmed TTBI by half for PC (p = 0.0052). The RR for confirmed PC-caused TTBI with fatal outcome was 1.4 cases per million units transfused. Regardless of type of blood product transfused and outcome of SAR, the majority of TTBI occurred after administration of a product at the end of shelf life (40.0%) and to recipients of advanced age (median age: 68.5 years) and/or with severe immunosuppression (72.5%) due to decreased myelopoiesis (62.5%). 72.5% of the involved bacteria had a middle/high human pathogenicity. Conclusion: Despite a significant decrease in confirmed TTBI following PC transfusion in Germany after implementation of RMM, the current manufacture of blood products can still not prevent TTBI with fatal outcomes. As demonstrated in various countries, RMM like bacterial screening or pathogen reduction may measurably improve the safety of blood transfusion.

16.
Transfusion ; 63(6): 1161-1171, 2023 06.
Article in English | MEDLINE | ID: mdl-37060282

ABSTRACT

BACKGROUND: Pulmonary complications of blood transfusion, including transfusion-related acute lung injury (TRALI), transfusion-associated circulatory overload (TACO), and transfusion-associated dyspnea, are generally underdiagnosed and under-reported. The international TRALI and TACO definitions have recently been updated. Currently, no standardized pulmonary transfusion reaction reporting form exists and most of the hemovigilance forms have not yet incorporated the updated definitions. We developed a harmonized reporting form, aimed at improved data collection on pulmonary transfusion reactions for hemovigilance and research purposes by developing a standardized model reporting form and flowchart. MATERIALS AND METHODS: Using a modified Delphi method among an international, multidisciplinary panel of 24 hemovigilance experts, detailed recommendations were developed for a standardized model reporting form for pulmonary complications of blood transfusion. Two Delphi rounds, including scoring systems, took place and several subsequent meetings were held to discuss issues and obtain consensus. Additionally, a flowchart was developed incorporating recently published redefinitions of pulmonary transfusion reactions. RESULTS: In total, 17 participants completed the first questionnaire (70.8% response rate) and 14 participants completed the second questionnaire (58.3% response rate). According to the results from the questionnaires, the standardized model reporting form was divided into various subcategories: general information, patient history and transfusion characteristics, reaction details, investigations, treatment and supportive care, narrative, and transfused product. CONCLUSION: In this article, we present the recommendations from a global group of experts in the hemovigilance field. The standardized model reporting form and flowchart provide an initiative that may improve data collected to address pulmonary transfusion reactions.


Subject(s)
Transfusion Reaction , Transfusion-Related Acute Lung Injury , Humans , Transfusion-Related Acute Lung Injury/epidemiology , Transfusion-Related Acute Lung Injury/etiology , Software Design , Blood Transfusion , Lung , Transfusion Reaction/complications
17.
Transfusion ; 63(4): 711-723, 2023 04.
Article in English | MEDLINE | ID: mdl-36802055

ABSTRACT

BACKGROUND: France converted to universal pathogen reduced (PR; amotosalen/UVA) platelets in 2017 and extended platelet component (PC) shelf-life from 5- to 7-days in 2018 and 2019. Annual national hemovigilance (HV) reports characterized longitudinal PC utilization and safety over 11 years, including several years prior to PR adoption as the national standard of care. METHODS: Data were extracted from published annual HV reports. Apheresis and pooled buffy coat [BC] PC use was compared. Transfusion reactions (TRs) were stratified by type, severity, and causality. Trends were assessed for three periods: Baseline (2010-14; ~7% PR), Period 1 ([P1] 2015-17; 8%-21% PR), and Period 2 ([P2] 2018-20; 100% PR). RESULTS: PC use increased by 19.1% between 2010 and 2020. Pooled BC PC production increased from 38.8% to 68.2% of total PCs. Annual changes in PCs issued averaged 2.4% per year at baseline, -0.02% (P1) and 2.8% (P2). The increase in P2 coincided with a reduction in the target platelet dose and extension to 7-day storage. Allergic reactions, alloimmunization, febrile non-hemolytic TRs, immunologic incompatibility, and ineffective transfusions accounted for >90% of TRs. Overall, TR incidence per 100,000 PCs issued declined from 527.9 (2010) to 345.7 (2020). Severe TR rates declined 34.8% between P1-P2. Forty-six transfusion-transmitted bacterial infections (TTBI) were associated with conventional PCs during baseline and P1. No TTBI were associated with amotosalen/UVA PCs. Infections with Hepatitis E (HEV) a non-enveloped virus resistant to PR, were reported in all periods. DISCUSSION: Longitudinal HV analysis demonstrated stable PC utilization trends with reduced patient risk during conversion to universal 7-day amotosalen/UVA PCs.


Subject(s)
Platelet Transfusion , Transfusion Reaction , Humans , Platelet Transfusion/adverse effects , Blood Safety , Blood Platelets/microbiology , Blood Transfusion , Transfusion Reaction/epidemiology , Transfusion Reaction/prevention & control , Bacteria
18.
Transfus Clin Biol ; 30(1): 166-172, 2023 Feb.
Article in English | MEDLINE | ID: mdl-36216308

ABSTRACT

Since its emergence in the early 1990s, hemovigilance has gradually evolved from a blood safety concept focused on surveillance of adverse reactions and events in patients, to a well-defined system that monitors the entire transfusion chain and improves its safety. The importance of hemovigilance has been recognized globally in a relatively short time, but the level of its implementation varies significantly between countries. The cooperation of international organizations has significantly contributed to the promotion, implementation, and education in this field. Thanks to initiatives taken, the safety of transfusion practice has been improved in many segments, primarily related to the risks of adverse events in recipients of blood components. In parallel with changing transfusion practice, the hemovigilance process has also matured. In addition to the reduction of existing risks and the early detection of emerging risks, hemovigilance has also embraced the principles of patient blood management. Research in hemovigilance is more increasingly focused on specific categories of patients, specific blood components and methods of their preparation, rare reactions, and transfusion efficacy and efficiency. A proactive approach and use of big data can play an important role in achieving these goals. Additional and sustained efforts should be made to prevent underreporting of events and to improve data comparability through clear definitions and grading systems. This review provides a historical overview of hemovigilance and its achievements, current challenges, and future plans.


Subject(s)
Blood Safety , Blood Transfusion , Humans , Blood Component Transfusion/adverse effects
19.
Transfus Clin Biol ; 30(1): 147-165, 2023 Feb.
Article in English | MEDLINE | ID: mdl-36031180

ABSTRACT

Many patients worldwide receive platelet components (PCs) through the transfusion of diverse types of blood components. PC transfusions are essential for the treatment of central thrombocytopenia of diverse causes, and such treatment is beneficial in patients at risk of severe bleeding. PC transfusions account for almost 10% of all the blood components supplied by blood services, but they are associated with about 3.25 times as many severe reactions (attributable to transfusion) than red blood cell transfusions after stringent in-process leukoreduction to less than 106 residual cells per blood component. PCs are not homogeneous, due to the considerable differences between donors. Furthermore, the modes of PC collection and preparation, the safety precautions taken to limit either the most common (allergic-type reactions and febrile non-hemolytic reactions) or the most severe (bacterial contamination, pulmonary lesions) adverse reactions, and storage and conservation methods can all result in so-called PC "storage lesions". Some storage lesions affect PC quality, with implications for patient outcome. Good transfusion practices should result in higher levels of platelet recovery and efficacy, and lower complication rates. These practices include a matching of tissue ABH antigens whenever possible, and of platelet HLA (and, to a lesser extent, HPA) antigens in immunization situations. This review provides an overview of all the available information relating to platelet transfusion, from donor and donation to bedside transfusion, and considers the impact of the measures applied to increase transfusion efficacy while improving safety and preventing transfusion inefficacy and refractoriness. It also considers alternatives to platelet component (PC) transfusion.


Subject(s)
Platelet Transfusion , Thrombocytopenia , Humans , Adult , Platelet Transfusion/adverse effects , Platelet Transfusion/methods , Blood Platelets/microbiology , Thrombocytopenia/therapy , Blood Transfusion , Blood Component Transfusion/adverse effects
20.
Transfus Clin Biol ; 30(1): 96-102, 2023 Feb.
Article in English | MEDLINE | ID: mdl-36162622

ABSTRACT

BACKGROUND: National Hemovigilance Programme aims at improving patient and donor outcomes by monitoring adverse reactions. This requires an additional effort by existing manpower that is already a handful and may offer a leeway if not mandated and designated to a hemovigilance nurse. AIMS AND OBJECTIVES: To analyse the reported adverse transfusion reactions (ATR) and their subsequent uplink/upload into the Hemovigilance program of India (HvPI) and to observe subjective discrepancy in the diagnosis of ATR and their imputability to transfusion. MATERIAL AND METHODS: ATR were analysed from May 2016 to October 2021 in a hospital-based blood centre in India. Two groups were formed, Group I constituted ATR that were reported and uplinked to HvPI, and Group II constituted all reported ATR irrespective of the uplink/upload. All ATR were reanalysed for a subjective discrepancy in diagnosis and imputability levels. Results were analysed online statistical software MedCalc using the "Exact Poissons Method" and the Chi-square test with a significant p-value of <0.05. RESULTS: In total 169 ATR were reported in 166 patients and 89 (52.6%) were uplinked, with an incident rate of 1 in 1412 and 1 in 743 in Group I and Group II respectively. The difference was statistically significant (p < 0.0001). Allergic reactions were the most common type in both groups followed by FNHTR with PRBC as the most implicated blood product. A discrepancy of around 4.3% and 17.9% in diagnosis and imputability level respectively was observed. CONCLUSIONS: The difference in incidence rates in the two groups indicates a mandate for dedicated hemovigilance nurses in every centre to aid in accurate data sharing with the National hemovigilance systems. Discrepancies in diagnosis can be mitigated by identification and understanding of ATR through case-based objective approach. Discrepancy in assigning imputability levels to adverse reactions can be minimised by objectifying the scales followed by spreading awareness though campaigns. These initiatives can effectively be aided by the hemovigilance nurse.


Subject(s)
Blood Safety , Transfusion Reaction , Humans , Transfusion Reaction/epidemiology , Blood Transfusion , Hospitals , India/epidemiology
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