The science or not behind deferrals of blood donors with a history of cancer.

BACKGROUND: In the United States (US), each blood center's medical director sets policy for donors with a cancer history. STUDY DESIGN AND METHODS: A subgroup of America's Blood Centers' (ABC) Scientific, Medical, and Technical Committee developed a survey to measure the determination of eligibility, policies for deferral and/or lookback when a donor reports a current diagnosis or history of cancer. A 31-question survey was sent to 47 ABC blood centers in North America via email. Survey results were compiled and literature evaluating the risk of cancer transmission by transfusion was reviewed. RESULTS: Responses were received from 37 centers (79%). Donors with a history of carcinoma or sarcoma who had completed treatment were accepted at 73% of centers with no further deferral. Donors with a history of leukemia or lymphoma were permanently deferred at 76% of centers. Donors with a myelodysplastic or myeloproliferative syndrome were deferred permanently at 86% of centers. Handling of donors with high white cell counts varied. Donors with cancer not in active treatment (i.e., prostate cancer) were subject to various deferrals. Center response to post-donation reports of cancer vary widely. Literature review yielded no evidence of transfusion-transmitted cancer. CONCLUSION: Cancer deferral policies vary widely among blood centers, and are not generally based on evidence, but on some aspect of the precautionary principle. As the donor population ages and so becomes more at risk of cancer, this approach may further reduce the available donor pool.

Estimated US Infection- and Vaccine-Induced SARS-CoV-2 Seroprevalence Based on Blood Donations, July 2020-May 2021.

Importance: People who have been infected with or vaccinated against SARS-CoV-2 have reduced risk of subsequent infection, but the proportion of people in the US with SARS-CoV-2 antibodies from infection or vaccination is uncertain. Objective: To estimate trends in SARS-CoV-2 seroprevalence related to infection and vaccination in the US population. Design, Setting, and Participants: In a repeated cross-sectional study conducted each month during July 2020 through May 2021, 17 blood collection organizations with blood donations from all 50 US states; Washington, DC; and Puerto Rico were organized into 66 study-specific regions, representing a catchment of 74% of the US population. For each study region, specimens from a median of approximately 2000 blood donors were selected and tested each month; a total of 1 594 363 specimens were initially selected and tested. The final date of blood donation collection was May 31, 2021. Exposure: Calendar time. Main Outcomes and Measures: Proportion of persons with detectable SARS-CoV-2 spike and nucleocapsid antibodies. Seroprevalence was weighted for demographic differences between the blood donor sample and general population. Infection-induced seroprevalence was defined as the prevalence of the population with both spike and nucleocapsid antibodies. Combined infection- and vaccination-induced seroprevalence was defined as the prevalence of the population with spike antibodies. The seroprevalence estimates were compared with cumulative COVID-19 case report incidence rates. Results: Among 1 443 519 specimens included, 733 052 (50.8%) were from women, 174 842 (12.1%) were from persons aged 16 to 29 years, 292 258 (20.2%) were from persons aged 65 years and older, 36 654 (2.5%) were from non-Hispanic Black persons, and 88 773 (6.1%) were from Hispanic persons. The overall infection-induced SARS-CoV-2 seroprevalence estimate increased from 3.5% (95% CI, 3.2%-3.8%) in July 2020 to 20.2% (95% CI, 19.9%-20.6%) in May 2021; the combined infection- and vaccination-induced seroprevalence estimate in May 2021 was 83.3% (95% CI, 82.9%-83.7%). By May 2021, 2.1 SARS-CoV-2 infections (95% CI, 2.0-2.1) per reported COVID-19 case were estimated to have occurred. Conclusions and Relevance: Based on a sample of blood donations in the US from July 2020 through May 2021, vaccine- and infection-induced SARS-CoV-2 seroprevalence increased over time and varied by age, race and ethnicity, and geographic region. Despite weighting to adjust for demographic differences, these findings from a national sample of blood donors may not be representative of the entire US population.

Detection of Babesia RNA and DNA in whole blood samples from US blood donations.

BACKGROUND: Human babesiosis is a zoonotic infection caused by an intraerythrocytic parasite. The highest incidence of babesiosis is in the United States, although cases have been reported in other parts of the world. Due to concerns of transfusion-transmitted babesiosis, the US Food and Drug Administration (FDA) recommended year-round regional testing for Babesia by nucleic acid testing or use of an FDA-approved device for pathogen reduction. A new molecular test, cobas Babesia (Roche Molecular Systems, Inc.), was evaluated for the detection of the four species that cause human disease, Babesia microti, Babesia duncani, Babesia divergens, and Babesia venatorum. STUDY DESIGN AND METHODS: Analytical performance was evaluated followed by clinical studies on whole blood samples from US blood donations collected in a special tube containing a chaotropic reagent that lyses the red cells and preserves nucleic acid. Sensitivity and specificity of the test in individual samples (individual donation testing [IDT]) and in pools of six donations were determined. RESULTS: Based on analytical studies, the claimed limit of detection of cobas Babesia for B. microti is 6.1 infected red blood cells (iRBC)/mL (95% confidence interval [CI]: 5.0, 7.9); B. duncani was 50.2 iRBC/mL (95% CI: 44.2, 58.8); B. divergens was 26.1 (95% CI: 22.3, 31.8); and B. venatorum was 40.0 iRBC/mL (95% CI: 34.1, 48.7). The clinical specificity for IDT was 99.999% (95% CI: 99.996, 100) and 100% (95% CI: 99.987, 100) for pools of six donations. CONCLUSION: cobas Babesia enables donor screening for Babesia species with high sensitivity and specificity.

Heterogeneity in Approaches for Switching From Universal to Patient ABO Type-Specific Blood Components During Massive Hemorrhage.

CONTEXT.­: ABO mistransfusions are rare and potentially fatal events. Protocols are required by regulatory agencies to minimize this risk to patients, but how these are applied in the context of massive transfusion protocols (MTPs) is not specifically defined. OBJECTIVE.­: To evaluate the approaches used by transfusion services for switching from universally compatible to patient ABO type-specific blood components during massive hemorrhage. DESIGN.­: We added 1 supplemental multiple-choice question to address the study objective to the 2019 College of American Pathologists proficiency test J-survey (J-A 2019). We also reviewed the available literature regarding this topic. RESULTS.­: A total of 881 laboratories responded to the supplemental question. Approximately 80% (704 of 881) reported a policy for ABO-type switching during an MTP. Policies varied considerably between responding laboratories, but most (384 of 704, 55%) required 2 ABO types to match before switching from universal to recipient-specific blood components. Additional safety measures used in a minority of these protocols included reaction strength criteria (103 of 704, 15%), on-call medical director approval (41 0f 704, 5.8%), universal red cell unit number limits (12 of 704, 1.7%), or the presence of a mixed field (3 of 704, 0.4%). CONCLUSIONS.­: This survey reveals that significant heterogeneity exists regarding the available approaches for ABO-type switching during an MTP. Specific expert guidance regarding this issue is very limited, and best practices have not yet been established or rigorously investigated.

A national survey of hospital-based transfusion services on their approaches to platelet bacterial risk mitigation in response to the FDA final guidance for industry.

BACKGROUND: Bacterial contamination of platelets is the leading infectious risk to the United States (US) blood supply. On 30 September 2019, the US Food and Drug Administration (FDA) published a Final Guidance for Industry to reduce the risk of transfusing platelets contaminated by bacteria. A national survey was undertaken to assess readiness, attitudes, and the potential impact on hospital-based transfusion services. STUDY DESIGN AND METHODS: A survey was distributed to transfusion services in all 50 US states. Summary statistics were performed along with review and categorization of email feedback and free text comments. RESULTS: Eighty-three transfusion services from 48 states participated in this survey study. Currently, the most common approach is primary culture performed at manufacturing (n = 49/83, 59%). Of the bacterial risk mitigation strategies provided by the FDA, the most frequently preferred are (a) pathogen reduced platelets (PRP) for up to 5-day storage (n = 36/77, 47%), (b) large volume delayed sampling (LVDS) ≥48 hours for up to 7-day storage (n = 16/77, 21%), and (c) primary culture ≥24 hours + secondary rapid testing for up to 7-day storage (n = 7/77, 9%). The main motivating factors for the survey participants' selected strategies to comply with FDA final guidance were product availability from supplier, reducing the risk of septic transfusion reactions (STR), and complexity of implementing and performing a new or additional test. CONCLUSION: While having platelets to transfuse and preventing STR are of the utmost importance, nationwide, the majority of transfusion services do not want to take on performing new or additional testing in their laboratories.

Evaluation and improvement of blood donor educational materials: results from a multicenter randomized controlled trial.

BACKGROUND: Blood collection centers are charged with creating donor educational materials (DnEM) that are easily understood across all prospective donor populations, while addressing mandates and recommendations from regulatory agencies and professional standard setting organizations. Donors must have sufficient information to understand the donation process with its risks and benefits, time to consider options before deciding, and opportunity to choose whether to proceed with or decline donating. The goal of this multisite randomized controlled trial was to evaluate knowledge acquired using standardized DnEM. America's Blood Centers' Working Group (WG) for Donor Education and Communication was formed to evaluate and suggest modifications of these documents. Based on pilot work, a randomized clinical trial was designed to test donor knowledge across a variety of populations. The WG identified several shortcomings in the current DnEM and proposed new DnEM. The new DnEM were tested against the same, current DnEM being used at all three sites (Blood Donor Educational Material, 2016 version 2.0, published in conjunction with the AABB uniform donor history questionnaire). METHODS AND MATERIALS: One-hundred sixty-five first time and returning donors were randomized in a 2x2 model to review either new DnEM or current DnEM. Every participant completed a pre- and post-quiz that tested their understanding of the DnEM. RESULTS: Returning donors had greater baseline knowledge compared to new donors, but new donors improved more versus returning donors. Donors using the new DnEM showed greater improvement in knowledge than those using current DnEM. CONCLUSION: Comprehension of DnEM can be improved. With this sample size the results suggest that the findings are independent of demographic characteristics, but a larger study would be necessary to confirm this.

Impact of autologous blood transfusion after bone marrow harvest on unrelated donor's health and outcome: a CIBMTR analysis.

Pre-harvest autologous blood collection from bone marrow (BM) donors is performed to meet potential post-operative transfusion needs. This study examines the impact of autologous blood transfusion on BM donor's health and safety. The study included first-time unrelated BM donors from the United States whose BM harvest was facilitated by the National Marrow Donor Program (NMDP) centers between 2006 and 2017. Examination of 7024 BM donors revealed that 60% received at least one unit of autologous blood. The donors who received autologous blood were older, had lower hemoglobin pre-harvest, underwent longer duration of anesthesia, and higher volume BM harvest. Only donors who underwent high-volume BM harvest, defined as a BM harvest volume >27% of donor's blood volume, benefited from autologous transfusion. After a high-volume BM harvest, autologous blood transfusion was shown to decrease grade 2 to 4 collection-associated toxicities within 48 h of BM donation (p = 0.010) and shorten the time to donor-reported "complete" recovery from donation-associated symptoms (p < 0.001). Therefore, autologous transfusion could be avoided as support of marrow donation in the majority of unrelated BM donors and should be limited to cases where the planned BM harvest volume is expected to exceed 27% of donor's blood volume.

Whole Blood for Resuscitation in Adult Civilian Trauma in 2017: A Narrative Review.

After a hiatus of several decades, the concept of cold whole blood (WB) is being reintroduced into acute clinical trauma care in the United States. Initial implementation experience and data grew from military medical applications, followed by more recent development and data acquisition in civilian institutions. Anesthesiologists, especially those who work in acute trauma facilities, are likely to be presented with patients either receiving WB from the emergency department or may have WB as a therapeutic option in massive transfusion situations. In this focused review, we briefly discuss the historical concept of WB and describe the characteristics of WB, including storage, blood group compatibility, and theoretical hemolytic risks. We summarize relevant recent retrospective military and preliminary civilian efficacy as well as safety data related to WB transfusion, and describe our experience with the initial implementation of WB transfusion at our level 1 trauma hospital. Suggestions and collective published experience from other centers as well as ours may be useful to those investigating such a program. The role of WB as a significant therapeutic option in civilian trauma awaits further prospective validation.

Changes in plasma unit distributions to hospitals over a 10-year period.

BACKGROUND: There are many influences on a hospital's demand for plasma. Pharmaceuticals are now being administered for many indications instead of plasma, although trauma resuscitation now emphasizes increased and early intervention with plasma. This multinational study evaluated changes in blood center plasma unit distributions over a 10-year period. STUDY DESIGN AND METHODS: Data on the total number and the ABO groups of plasma unit distributions were obtained from nine American blood collectors (ABCs) and nine national or provincial blood services (NPBS) from 2007 through 2016. Plasma distributions to trauma hospitals by five ABCs and four NPBS were also analyzed. RESULTS: The overall number of plasma unit distributions from ABCs decreased by 23.1% from 2007 to 2016, but the relative proportion of distributed AB plasma units increased during the same period. The NPBS (excluding the Japanese Red Cross [JRC]) also had a 35.4% decrease in the overall number of plasma unit distributions with an increase in the relative proportion of AB plasma distributions between 2007 and 2016. The JRC, however, reported an increase in the overall number of plasma distributions by 13.5% in 2016 compared to 2007. The proportion of low-titer A plasma distributions increased to 1.6% of total plasma distributions by ABCs in 2016. There was a trend of distributing increasing proportions of group AB plasma units to trauma hospitals over the 10-year period. CONCLUSION: Although the number of plasma unit distributions has decreased at many blood collectors over time, the proportion of AB units has increased at both ABCs and NPBS.

Likely Autochthonous Transmission of Trypanosoma cruzi to Humans, South Central Texas, USA.

Chagas disease, caused by Trypanosoma cruzi, is a major neglected tropical disease affecting the Americas. The epidemiology of this disease in the United States is incomplete. We report evidence of likely autochthonous vectorborne transmission of T. cruzi and health outcomes in T. cruzi-seropositive blood donors in south central Texas, USA.

First Zika-positive donations in the continental United States.

BACKGROUND: Zika virus (ZIKV) has spread in the Americas, including parts of the southern United States, and infection can be associated with serious complications, including congenital brain abnormalities. Probable transfusion transmission of ZIKV has been documented in Brazil. STUDY DESIGN AND METHODS: Preemptive testing of blood donations for ZIKV RNA was implemented in southern US states at risk of local transmission using a test approved under a Food and Drug Administration (FDA) investigational new drug application, cobas Zika. Screening was expanded after issuance of an updated FDA guidance. Donations reactive on initial screening were further tested by nucleic acid and antibody tests to determine the donor status. RESULTS: Of 358,786 donations from US states screened by individual donation testing, 23 were initially reactive on cobas Zika. Fourteen of these represented probable ZIKV infection based on reactivity on additional nucleic acid testing or anti-Zika immunoglobulin M. Ten of the 14 donors reported travel to an identified ZIKV-active area within 90 days before donation (median time from end of travel to donation, 25 days; range, 6-71 days). Three donors with travel history also had a potential sexual exposure. Only seven of the 14 donations with probable ZIKV infection were detectable upon 1:6 dilution to simulate minipool testing. The estimated specificity of the cobas Zika test was 99.997%. CONCLUSION: Screening of donations for ZIKV RNA can interdict ZIKV-infected donors. Donor risk factors include travel more than 4 weeks before donation and sexual exposure. Minipool screening would have detected only 50% of the RNA-positive donations.

Zika and the Blood Supply: A Work in Progress.

Zika virus can be transmitted by transfusion, but the harm caused to recipients is not clear in most cases. It is very likely that the virus could also be transmitted by transplanted organs. Sensitivity to the risk from transfusion is elevated by consideration of possible severe neurologic damage in fetuses. Strategies for dealing with transfusion risk vary with the presence of Zika in the region. In nonendemic areas, risks can be reduced by excluding donors who have exposure through travel or sexual contact with someone at risk. In both endemic and nonendemic areas, the risk can be further reduced by nucleic acid testing of donors, or pathogen reduction of platelet and plasma products. The real risk to the population depends on the frequency of infection as well as the efficacy of these interventions. The interventions chosen will depend on the risk assessment for any situation; in the United States at this time, a combination of travel deferrals, testing, and, to a lesser extent, pathogen reduction is being used, but universal testing of US blood donors under investigational use has been mandated by the US Food and Drug Administration, beginning with states most at risk of local transmission. Canada is largely using travel deferrals. A precautionary approach may be taken; however, a formal decision-making framework has been suggested. The situation globally is clearly very fluid, as the epidemic continues to spread and we continue to learn how to best protect recipients of blood and transplants.

Anti-Vel alloimmunization and severe hemolytic disease of the fetus and newborn.

CONCLUSIONS: Only rare cases of anti-Vel-associated mild-to-moderate hemolytic disease of the fetus and newborn have been previously reported. No case of fetal anemia requiring prenatal therapy has been noted to date. We report such a case recently encountered at our Fetal Center. Strategies are discussed for managing pregnancy complicated with alloimmunization to an antibody to a high-prevalence antigen, including sources of red blood cells for intrauterine transfusions.

Significant improvement in survival after unrelated donor hematopoietic cell transplantation in the recent era.

Patients and physicians may defer unrelated donor hematopoietic cell transplantation (HCT) as curative therapy because of the mortality risk associated with the procedure. Therefore, it is important for physicians to know the current outcomes data when counseling potential candidates. To provide this information, we evaluated 15,059 unrelated donor hematopoietic cell transplant recipients between 2000 and 2009. We compared outcomes before and after 2005 for 4 cohorts: age <18 years with malignant diseases (n = 1920), ages 18 to 59 years with malignant diseases (n = 9575), ages ≥ 60 years with malignant diseases (n = 2194), and nonmalignant diseases (n = 1370). Three-year overall survival in 2005 to 2009 was significantly better in all 4 cohorts (<18 years: 55% versus 45%, 18 to 59 years: 42% versus 35%, ≥ 60 years: 35% versus 25%, nonmalignant diseases: 69% versus 60%; P < .001 for all comparisons). Multivariate analyses in leukemia patients receiving HLA 7/8 to 8/8-matched transplants showed significant reduction in overall and nonrelapse mortality in the first year after HCT among patients who underwent transplantation in 2005 to 2009; however, risks for relapse did not change over time. Significant survival improvements after unrelated donor HCT have occurred over the recent decade and can be partly explained by better patient selection (eg, HCT earlier in the disease course and lower disease risk), improved donor selection (eg, more precise allele-level matched unrelated donors) and changes in transplantation practices.

Development of chagas cardiac manifestations among Texas blood donors.

Chagas disease, infection with the parasite Trypanosoma cruzi, has recently been identified as an important emerging parasitic disease in the United States. To describe the cardiac abnormalities in T. cruzi-positive blood donors in southeastern Texas, a pilot study of donors who had screened positive from 2007 to 2012 was performed. This one-time assessment included (1) a questionnaire to evaluate the source of infection, cardiac symptoms, and health co-morbidities; (2) electrocardiography; (3) echocardiography if electrocardiographic findings were abnormal; and (4) measurement of a high-sensitivity troponin T biomarker. Of those with confirmed infection, 41% (7 of 17) had electrocardiographic abnormalities consistent with Chagas cardiomyopathy. In addition, 36% (6 of 17) were suspected to be locally acquired cases. High-sensitivity troponin T serum levels increased with cardiac severity. In conclusion, cardiologists should consider Chagas disease in their differential diagnoses for patients who may have clinically compatible electrocardiographic changes or nonischemic cardiomyopathy, even if the patients have no histories of residing in Chagas-endemic countries.

Evidence of autochthonous Chagas disease in southeastern Texas.

Autochthonous transmission of Trypanosoma cruzi in the United States is rarely reported. Here, we describe five newly identified patients with autochthonously acquired infections from a small pilot study of positive blood donors in southeast Texas. Case-patients 1-4 were possibly infected near their residences, which were all in the same region ∼100 miles west of Houston. Case-patient 5 was a young male with considerable exposure from routine outdoor and camping activities associated with a youth civic organization. Only one of the five autochthonous case-patients received anti-parasitic treatment. Our findings suggest an unrecognized risk of human vector-borne transmission in southeast Texas. Education of physicians and public health officials is crucial for identifying the true disease burden and source of infection in Texas.