BACKGROUND:In May 2023, the Food and Drug Administration (FDA) released final guidance for blood donor eligibility that recommended the elimination of 3-month deferral for men who have sex with men (MSM) and the related deferral for women who have sex with MSM. In its place, FDA introduced an individual risk assessment policy of asking all presenting blood donors, regardless of sex or gender, if they have had a new partner or more than one sexual partner in the last 3 months and deferring those who also report anal sex (penile-anal intercourse) during this period. We modeled the possible impact of this policy on the US blood donor base. STUDY DESIGN AND METHODS:We developed a computational model to estimate the percentage of blood donors who would be deferred under a policy of individual HIV risk assessment. The model incorporated demographic information about donors and national survey data on HIV risk behaviors and included age and sex distributions and dependencies. RESULTS:Our model estimates that approximately 1.2% of US blood donors would be deferred under the individual HIV risk assessment paradigm. DISCUSSION:The model predicts a relatively minor effect of replacing the time-based deferral for MSM with individual risk-based deferral for sexual behavior. As US blood centers implement this new policy, the effect may be mitigated by donor gains, which warrant further study. The new policy is unlikely to adversely affect the availability of blood and blood components.

Background and ObjectivesMalaria risk deferral policies are important for mitigating the risk of transfusion-transmitted malaria and apply to all transfusable components, including plasma. While donors of plasma components are deferred for malaria risk in the United States, the viability of intraerythrocytic Plasmodium falciparum parasites present in human plasma components stored under different temperatures and durations has not been previously reported.Materials and MethodsWe spiked human plasma with a low level of ring-stage P. falciparum-infected red blood cells and then determined their viability in cultures after storage at room temperature (22 degrees C), refrigeration (4 degrees C) and frozen conditions at -20 and -80 degrees C.ResultsP. falciparum parasites spiked in human plasma remained viable after storage at 22 degrees C for a maximum of 7 days. When stored at 4 degrees C, parasites were viable after 1 and 3 days of storage and only for 1 day after storage at -20 degrees C. Storage at -80 degrees C had a cryopreserving effect and parasites remained viable for up to 176 days, the longest period tested.ConclusionP. falciparum parasites can survive for short durations in human plasma when stored at room temperature, or in refrigerated or frozen conditions at -20 degrees C. However, when stored at -80 degrees C, viable parasites were detected for up to 176 days, the maximum duration for which viability was assessed. In summary, Plasmodium parasites can survive in human plasma under different storage conditions and pose a risk of transfusion-transmitted infection.

Importance Blood donor selection policies should be evidence-based. Individual risk assessment allows potential donors to be evaluated based on their own behaviors.Objective The Assessing Donor Variability and New Concepts in Eligibility (ADVANCE) study examined behavioral and biomarkers of HIV risk in sexually active men who have sex with men (MSM) to estimate the proportion of the study population who would not be deferred for higher risk HIV sexual behaviors and might be eligible to donate.Design A cross-sectional assessment of sexually active MSM interested in blood donation. Setting: An 8-city study of MSM aged 18 – 39 years assigned male sex at birth.Interventions or Exposures Participants completed surveys during 2 study visits to define eligibility, self-reported sexual and HIV prevention behaviors. Blood was drawn at study visit 1 and tested for HIV and the presence of tenofovir, 1 of the drugs in oral HIV pre-exposure prophylaxis (PrEP).Main Outcomes and Measures Associations between HIV infection status or HIV PrEP use and self-reported HIV risk behaviors, including number of male sex partners, new partners, and anal sex.Results Among 1788 screened MSM, 1593 were eligible and 1566 completed the visit 1 HIV risk questionnaire and blood draw. A median of 22 days later, 1197 completed the visit 2 follow-up questionnaire. Four individuals tested HIV positive (0.25%). Among HIV-negative participants, 789 (50.4%) reported no PrEP use in the past 3 months. The number of sex partners in the past 3 months was significantly higher among PrEP users versus non-users, as was the number reporting a new male sex partner in the same period. Among HIV-negative, non-PrEP using participants, 66.2% reported only 1 sexual partner or no anal sex and 69% reported no new sexual partners or no anal sex with a new partner in the past 3 months.Conclusion and Relevance Among sexually active MSM, there are subgroups who self-report no new sexual partners and only 1 sexual partner within the past 3 months. These individuals are likely at lower risk of HIV infection than other MSM and would meet proposed individual risk assessment criteria for blood donation in the U.S.Question Can a set of blood donor screening questions based on individual behaviors identify a population of lower HIV risk men who have sex with men (MSM) who wish to donate blood?Findings In this cross-sectional study of 1566 enrolled MSM, among 1562 persons without HIV, 789 (50.4%) were not taking pre-exposure prophylaxis (PrEP). Of those not taking PrEP, 66.2% reported only 1 sexual partner or no anal sex and 69% reported no new sexual partners or no anal sex with a new partner in the past 3 months.Meaning Potential blood donor history questions were able to identify sexually active MSM with lower-risk sexual behaviors who may be eligible to donate blood.### Competing Interest StatementThe authors have declared no competing interest.### Funding StatementThis study was funded by the U.S. Food and Drug Administration### Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:The Advarra Institutional Review Board (Columbia, MD) gave ethical approval for this work under protocol number 00043278.I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.YesData from this study are not openly available. Authors should be contacted to discuss data availability.

TransfusionVolume 63, Issue S5 p. 16A-16A SUPPLEMENT ARTICLE OA4-AM23-SN-19 | Transfusion-Transmitted Babesiosis Reported to Food and Drug Administration Before and after Implementation of the Final Guidance, 2017–2022 A. Eder, A. Eder Office of Blood Research and Review, CBER, FDASearch for more papers by this authorS. O'Callaghan, S. O'Callaghan Office of Compliance and Biologics Quality, CBER, FDASearch for more papers by this authorS. Kumar, S. Kumar Office of Blood Research and Review, CBER, FDASearch for more papers by this author A. Eder, A. Eder Office of Blood Research and Review, CBER, FDASearch for more papers by this authorS. O'Callaghan, S. O'Callaghan Office of Compliance and Biologics Quality, CBER, FDASearch for more papers by this authorS. Kumar, S. Kumar Office of Blood Research and Review, CBER, FDASearch for more papers by this author First published: 12 October 2023 https://doi.org/10.1111/trf.8_17554Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume63, IssueS5October 2023Pages 16A-16A RelatedInformation

CONTEXT.—:Modern RHD genotyping can be used to determine when patients with serologic weak D phenotypes have RHD gene variants at risk for anti-D alloimmunization. However, serologic testing, RhD interpretations, and laboratory management of these patients are quite variable. OBJECTIVE.—:To obtain interlaboratory comparisons of serologic testing, RhD interpretations, Rh immune globulin (RhIG) management, fetomaternal hemorrhage testing, and RHD genotyping for weak D-reactive specimens. DESIGN.—:We devised an educational exercise in which 81 transfusion services supporting obstetrics performed tube-method RhD typing on 2 unknown red blood cell challenge specimens identified as (1) maternal and (2) newborn. Both specimens were from the same weak D-reactive donor. The exercise revealed how participants responded to these different clinical situations. RESULTS.—:Of reporting laboratories, 14% (11 of 80) obtained discrepant immediate-spin reactions on the 2 specimens. Nine different reporting terms were used to interpret weak D-reactive maternal RhD types to obstetricians. In laboratories obtaining negative maternal immediate-spin reactions, 28% (16 of 57) performed unwarranted antiglobulin testing, sometimes leading to recommendations against giving RhIG. To screen for excess fetomaternal hemorrhage after a weak D-reactive newborn, 47% (34 of 73) of reporting laboratories would have employed a contraindicated fetal rosette test, risking false-negative results and inadequate RhIG coverage. Sixty percent (44 of 73) of laboratories would obtain RHD genotyping in some or all cases. CONCLUSIONS.—:For obstetric and neonatal patients with serologic weak D phenotypes, we found several critical problems in transfusion service laboratory practices. We provide recommendations for appropriate testing, consistent immunohematologic terminology, and RHD genotype-guided management of Rh immune globulin therapy and RBC transfusions.

During May 2018‒December 2022, we reviewed transfusion-transmitted sepsis cases in the United States attributable to polymicrobial contaminated apheresis platelet components, including Acinetobacter calcoaceticus‒baumannii complex or Staphylococcus saprophyticus isolated from patients and components. Transfused platelet components underwent bacterial risk control strategies (primary culture, pathogen reduction or primary culture, and secondary rapid test) before transfusion. Environmental samples were collected from a platelet collection set manufacturing facility. Seven sepsis cases from 6 platelet donations from 6 different donors were identified in patients from 6 states; 3 patients died. Cultures identified Acinetobacter calcoaceticus‒baumannii complex in 6 patients and 6 transfused platelets, S. saprophyticus in 4 patients and 4 transfused platelets. Whole-genome sequencing showed environmental isolates from the manufacturer were closely related genetically to patient and platelet isolates, indicating the manufacturer was the most probable source of recurrent polymicrobial contamination. Clinicians should maintain awareness of possible transfusion-transmitted sepsis even when using bacterial risk control strategies.

BACKGROUND:Individual risk assessment allows donors to be evaluated based on their own behaviors. Study objectives were to assess human immunodeficiency virus (HIV) risk behaviors in men who have sex with men (MSM) and estimate the proportion of the study population who would not be deferred for higher risk HIV sexual behaviors. STUDY DESIGN AND METHODS:Cross-sectional survey and biomarker assessment were conducted in eight U.S. cities. Participants were sexually active MSM interested in blood donation aged 18-39 years, assigned male sex at birth. Participants completed surveys during two study visits to define eligibility, and self-reported sexual and HIV prevention behaviors. Blood was drawn at study visit 1 and tested for HIV and the presence of tenofovir, one of the drugs in oral HIV pre-exposure prophylaxis (PrEP). Associations were assessed between HIV infection status or HIV PrEP use and behaviors, including sex partners, new partners, and anal sex. RESULTS:A total of 1566 MSM completed the visit 1 questionnaire and blood draw and 1197 completed the visit 2 questionnaire. Among 1562 persons without HIV, 789 (50.4%) were not taking PrEP. Of those not taking PrEP, 66.2% reported one sexual partner or no anal sex and 69% reported no new sexual partners or no anal sex with a new partner in the past 3 months. CONCLUSION:The study found that questions were able to identify sexually active, HIV-negative MSM who report lower risk sexual behaviors. About a quarter of enrolled study participants would be potentially eligible blood donors using individual risk assessment questions.

Alpha-gal syndrome (AGS) is a potentially life-threatening acquired meat allergy associated with tick bites. The allergen Galactose-α-1,3-Galactose is antigenically similar to the B blood group antigen. B blood group status offers some protection against development of the allergy. Although not preferred practice, transfusion of plasma and platelets from group B donors is believed to be safe for group O recipients. Anaphylactic transfusion reactions were reported for three patients in two Washington DC hospitals from Nov 2022 to February 2023. A chart review was performed for all three patients. Patients or family members were interviewed, and IgE levels to alpha-gal were measured in two of the three patients. One reaction was acutely fatal. All reactions were to blood group B Plasma or Platelets in blood group O recipients. One patient had two prior anaphylactic reactions to group O RBCs and group B Plasma in a previous admission. All patients came from southern Maryland where AGS is an emerging problem. Two patients had histories of tick bites, previously unexplained gastrointestinal complaints, and abnormal elevated levels of IgE to alpha gal. Two patients had cat allergies. AGS is an emerging problem which may have implications for blood transfusion practice. Avoidance of blood group B antigen containing components may be prudent in non-blood group B patients with established AGS. Investigation for AGS should be considered in the evaluation of anaphylactic transfusion reactions.

TransfusionVolume 63, Issue S5 p. 141A-142A SUPPLEMENT ARTICLE P-BB-72 | Survival of Plasmodium Falciparum Parasites in Human Plasma Under Different Storage Temperatures A. Lavrentieva, A. Lavrentieva OBRR, CBER, FDASearch for more papers by this authorM. Oakley, M. Oakley OBRR, CBER, FDASearch for more papers by this authorV. Majam, V. Majam OBRR, CBER, FDASearch for more papers by this authorA. Eder, A. Eder Office of Blood Research and Review, CBER, FDASearch for more papers by this authorC. Villa, C. Villa OBRR, CBER, FDASearch for more papers by this authorS. Kumar, S. Kumar Office of Blood Research and Review, CBER, FDASearch for more papers by this author A. Lavrentieva, A. Lavrentieva OBRR, CBER, FDASearch for more papers by this authorM. Oakley, M. Oakley OBRR, CBER, FDASearch for more papers by this authorV. Majam, V. Majam OBRR, CBER, FDASearch for more papers by this authorA. Eder, A. Eder Office of Blood Research and Review, CBER, FDASearch for more papers by this authorC. Villa, C. Villa OBRR, CBER, FDASearch for more papers by this authorS. Kumar, S. Kumar Office of Blood Research and Review, CBER, FDASearch for more papers by this author First published: 12 October 2023 https://doi.org/10.1111/trf.176_17554Read the full textAboutPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onEmailFacebookTwitterLinkedInRedditWechat No abstract is available for this article. Volume63, IssueS5October 2023Pages 141A-142A RelatedInformation

Background: Blood donations are routinely screened for HIV to prevent an infectious unit from being released to the blood supply. Despite improvements to blood screening assays, donations from infected donors remain undetectable during the window period (WP), when the virus has not yet replicated above the lower limit of detection (LOD) of a screening assay. To aid in the quantitative risk assessments of WP donations, a dose–response model describing the probability of transfusion-transmission of HIV over a range of viral RNA copies was developed. Methods: An exponential model was chosen based on data fit and parsimony. A data set from a HIV challenge study using a nonhuman primate model and another data set from reported human blood transfusions associated with HIV infected donors were separately fit to the model to generate parameter estimates. A Bayesian framework using No-U-Turn Sampling (NUTS) and Monte Carlo simulations was performed to generate posterior distributions quantifying uncertainty in parameter estimation and model predictions. Results: The parameters of the exponential model for both nonhuman primate and human data were estimated with a mean (95% credible intervals) of 2.70 × 10−2 (7.74 × 10−3, 6.06 × 10−2) and 7.56 × 10−4 (3.68 × 10−4, 1.31 × 10−3), respectively. The predicted ID50 for the animal and human models was 26 (12, 90) and 918 (529, 1886) RNA copies transfused, respectively. Conclusion: This dose–response model can be used in a quantitative framework to estimate the probability of transfusion-transmission of HIV through WP donations. These models can be especially informative when assessing risk from blood components with low viral load.

Adverse reactions occur immediately or soon after a blood collection procedure or become apparent only over a longer period of time, after several blood donations. Most acute reactions that occur immediately or within a few hours after donating blood are mild or minor symptoms such as dizziness, lightheadedness, or phlebotomy-related bruises and hematomas that resolve promptly but are still unpleasant for the donor. Many studies have evaluated donor characteristics and other variables that influence the risk of immediate and delayed reactions after allogeneic blood donation. Phlebotomy-related nerve injuries are uncommon and typically resolve without sequelae within weeks, but in rare cases have longterm debilitating consequences. Citrate is used as an anticoagulant during apheresis procedures because it effectively chelates divalent cations such as calcium to transiently and immediately inhibit the coagulation cascade. Granulocyte collection poses unique risks to donors.

The efficacy of COVID-19 convalescent plasma (CCP) as a treatment for hospitalized patients with COVID-19 remains somewhat controversial; however, many studies have not evaluated CCP documented to have high neutralizing antibody titer by a highly accurate assay. To evaluate the correlation of the administration of CCP with titer determined by a live viral neutralization assay with 7- and 28-day death rates during hospitalization, a total of 23 118 patients receiving a single unit of CCP were stratified into two groups: those receiving high titer CCP (>250 50% inhibitory dilution, ID50; n = 13 636) or low titer CCP (≤250 ID50; n = 9482). Multivariable Cox regression was performed to assess risk factors. Non-intubated patients who were transfused with high titer CCP showed 1.1% and 1.7% absolute reductions in overall 7- and 28-day death rates, respectively, compared to those non-intubated patients receiving low titer CCP. No benefit of CCP was observed in intubated patients. The relative benefit of high titer CCP was confirmed in multivariable Cox regression. Administration of CCP with high titer antibody content determined by live viral neutralization assay to non-intubated patients is associated with modest clinical efficacy. Although shown to be only of modest clinical benefit, CCP may play a role in the future should viral variants develop that are not neutralized by other available therapeutics.

Background Human babesiosis is a mild-to-severe parasitic infection that poses health concerns especially in older and other at-risk populations. The study objective was to assess babesiosis occurrence among US Medicare beneficiaries, ages 65 and older, during 2006-2017. Methods Our retrospective claims-based study used Medicare databases. Babesiosis cases were identified using recorded diagnosis codes. The study estimated rates (per 100 000 beneficiary-years) overall, by year, diagnosis month, demographics, and state and county of residence. Results Nationwide, 19 469 beneficiaries had babesiosis recorded, at a rate of 6 per 100 000 person-years, ranging from 4 in 2006 to 9 in 2017 (P < .05). The highest babesiosis rates by state were in the following: Massachusetts (62), Rhode Island (61), Connecticut (51), New York (30), and New Jersey (19). The highest rates by county were in the following: Nantucket, Massachusetts (1089); Dukes, Massachusetts (236); Barnstable, Massachusetts (213); and Dutchess, New York (205). Increasing rates, from 2006 through 2017 (P < .05), were identified in multiple states, including states previously considered nonendemic. New Hampshire, Maine, Vermont, Pennsylvania, and Delaware saw rates increase by several times. Conclusions Our 12-year study shows substantially increasing babesiosis diagnosis trends, with highest rates in well established endemic states. It also suggests expansion of babesiosis infections in other states and highlights the utility of real-world evidence.

Background and objectivesWritten materials are commonly used for blood donor education. While pre‐donation materials are largely standardized across US blood collectors, the post‐donation instruction sheet (PDIS) is variable and few have been evaluated to assess their effectiveness in conveying information as reflected by donors’ attention, understanding and recall.MethodsAn online survey was sent to two independent randomly selected samples of repeat donors, before and after implementation of the enhanced PDIS.ResultsA total of 12 935 blood donors responded (33·4% response rate). Most donors did not read the entire PDIS ‐ 34·3% less than half and 18·1% none. Of the 10 593 donors who reported reading any of the PDIS, 97·8% recalled instructions about immediate post‐donation care (e.g. extra fluids/no exercise) and 88·0% to call with questions/problems. However, only 50·1% remembered reading about what to do if you felt dizzy/faint and 32·4% about care for bruises. Recall rates in every area were similar before and after revision; except after revision, more donors remembered seeing information about maintaining iron and fewer that you should call the centre back with additional health information (P < 0·0001).DiscussionBlood collectors rely heavily on written materials to convey instructions to donors. Most repeat donors do not read the entire PDIS, and many do not recall important information. More donors recalled seeing how to maintain iron with the enhanced PDIS, but recall deficits remained on how to care for adverse reactions. Written materials alone appear to be insufficient to educate some donors about new or updated topics.