Opportunities to improve feedback to reduce blood component wastage: Results of a national scheme evaluation.

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.

Australian fresh frozen plasma audit: A National Blood Transfusion Committee and Blood Matters collaboration.

BACKGROUND: There is a paucity of high-quality data to guide appropriate fresh frozen plasma transfusion with current recommendations based on consensus opinion. The limitations of the product and testing modalities are poorly understood with the rare but potentially serious side effects underappreciated. Combined this has resulted in the widespread misuse of FFP. STUDY DESIGN AND METHODS: Retrospective data capturing FFP transfusion within the 12-month period of April 1, 2022 and March 31, 2023 was entered by Australian health care providers. Appropriate transfusion was assessed by the adjudicators and defined as one in keeping with current recommendations. Descriptive and comparative analyses were performed using SAS Studio version 9.4. RESULTS: During the study period, 935 FFP transfusion episodes were captured. The most frequent indications for FFP were massive hemorrhage 344 (37%), bleeding 141 (15%), and preoperative use 90 (10%). Males received 534 (60%) transfusions. Critical care specialists were the largest users of FFP, prescribing 568 (63%) of transfusions. FFP was used appropriately in 546 (61%) transfusions. However, when massive hemorrhage was excluded only 202 (37%) transfusions were appropriate. Patients with an INR <1.5 received 37% of transfusions. Transfusion associated adverse events were reported in 2% (15) of transfusions including two non-fatal anaphylactic reactions. DISCUSSION: This audit assesses the appropriate use of FFP across all major clinical indications and provides the largest body of evidence of Australian plasma transfusion practices. It highlights the widespread misuse of FFP, which is predominantly guided by consensus recommendations due to a lack of high-quality data.

Characterization of transfusion-relevant bacteria reference strains in a lyophilized format.

BACKGROUND AND OBJECTIVES: Blood safety measures used by blood establishments to increase blood component safety can be validated using Transfusion-Relevant Bacterial Reference Strains (TRBRS). Ultra-cold storage conditions and manual preparation of the current TRBRS may restrict their practical use. To address this issue, the ISBT Transfusion-Transmitted Infectious Diseases Working Party's Bacterial Subgroup organized an international study to validate TRBRS in a user-friendly, lyophilised format. MATERIALS AND METHODS: Two bacterial strains Klebsiella pneumoniae PEI-B-P-08 and Staphylococcus aureus PEI-B-P-63 were manufactured as lyophilised material. The lyophilised bacteria were distributed to 11 different labs worldwide to assess the robustness for enumeration, identification and determination of growth kinetics in platelet concentrates (PCs). RESULTS: Production of lyophilised TRBRS had no impact on the growth properties compared with the traditional format. The new format allows a direct low-quantity spiking of approximately 30 bacteria in PCs for transfusion-relevant experiments. In addition, the lyophilised bacteria exhibit long-term stability across a broad temperature range and can even be directly rehydrated in PCs without losing viability. Interlaboratory comparative study demonstrated the robustness of the new format as 100% of spiked PC exhibited growth. CONCLUSION: Lyophilised TRBRS provide a user-friendly material for transfusion-related studies. TRBRS in the new format have improved features that may lead to a more frequent use in the quality control of transfusion-related safety measures in the future.

A national surveillance system for continuous monitoring of blood transfusion safety: German haemovigilance data.

BACKGROUND AND OBJECTIVES: Haemovigilance (HV) systems aim to improve transfusion outcomes in patients and donor safety. An important question for blood regulators is how to ensure an effective HV system. MATERIALS AND METHODS: We retrospectively analysed the HV reports submitted to Paul-Ehrlich-Institut over the last two decades. RESULTS: Between 2011 and 2020, 50.86 million units of blood components were used, and 8931 suspected serious donor and recipient adverse reactions (SARs), 874 serious adverse events (SAEs) and 12,073 donor look-backs were reported. Following implementation of specific risk-minimization measures (RMMs) between 2000 and 2010, SAR reporting rates decreased for transfusion-transmitted viral infections (TTVIs), transfusion-related acute lung injury (TRALI) and transfusion-transmitted bacterial infections (TTBIs), while increasing for other serious adverse transfusion reactions. Within this decade, the overall blood component use decreased. CONCLUSION: Long-term data collection forms the basis to establish trends and changes in reporting and to evaluate the effect of RMM. Standardized criteria for reaction types, seriousness and imputability assessments and availability of a denominator are important elements. Central data collection and independent assessment allow for monitoring HV data in a nationwide context over time. Stakeholder involvement and transparent feedback on the benefit of RMM will help to achieve the objectives of HV.

Hospital variation in quality indicators for patient blood management in total knee and hip arthroplasty: a retrospective cohort study.

BACKGROUND: Anaemia, blood loss, and blood transfusion are critical aspects of patient care in major orthopaedic surgery. We assessed hospital adherence to guideline-recommended Patient Blood Management (PBM) care, analysed variations between hospitals, and validated two composite indicators of hospital PBM performance in patients undergoing total knee arthroplasty (TKA) or total hip arthroplasty (THA). METHODS: This retrospective cohort study included all primary TKA and THA procedures performed during 2021 across 39 hospitals in Spain. We assessed hospital adherence to key guideline-recommended PBM interventions using nine individual quality indicators and two types of composite quality indicators (cQIs): opportunity-based (cQI1) and all-or-none (cQI2). We validated these cQIs by analysing their associations with the adjusted total transfusion index using linear regression. RESULTS: We included 8561 patient episodes from 33 hospitals in the analysis. Delivery of PBM care was similar for TKA and THA. Patients received 62% of the analysed PBM interventions and only 12% of patients underwent the full PBM pathway. Higher hospital cQIs scores were associated with a lower adjusted total transfusion index, both in TKA and THA. The greatest association was found for cQI1 in THA patients (ß=-1.18 [95% confidence interval -2.00 to -0.36]; P=0.007). CONCLUSIONS: Hospital adherence to guideline-recommended patient blood management care in total hip and knee arthroplasty was suboptimal and varied across centres. Using data that are widely available in hospitals, quality indicators and composite scores could become valuable tools for patient blood management monitoring and comparisons between healthcare organisations.

Establishment and discussion of autoverification rules for transfusion compatibility testing.

OBJECTIVES: To develop an automated verification workflow for transfusion compatibility testing (TCT) based on the AUTO10-A guidelines and blood group serology characteristics and to conduct a simulated validation of the test and subtest results by assessing the appropriateness of the autoverification rules. BACKGROUND: The accuracy of TCT results is a fundamental prerequisite for ensuring the safety of blood transfusions. However, the verification of these results still requires manual intervention. MATERIALS AND METHODS: Five autoverification rules and their standards were determined: agglutination intensity, normal results, logical relationships, delta checks and interlaboratory test comparisons. The established categories and standards for the five rules were retrospectively validated using 13 506 samples (requests) that had been manually verified in our laboratory from January 2020 to June 2023. RESULTS: A total of 66 638 test items were involved in the autoverification, with 3844 items violating the verification rules, resulting in a pass rate of 96.10%. Considering individual test items, four tests had a pass rate of more than 90% in both the test item result table and the test subitem result table. However, there were significant differences in the pass rates between different tests. The same conclusion can be drawn when the unit is requests. The different standards set for the agglutination intensity and the delta check in the ABO typing testing subitems showed significant differences in pass rates. DISCUSSION: The incorporation of manually verified results into the automated verification simulation indicated that the five rules established in this study have good applicability, and appropriate standards can lead to reasonable pass rates.

Prophylactic Transfusion Strategies in Children Supported by Extracorporeal Membrane Oxygenation: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE Consensus Conference.

OBJECTIVES: To derive systematic-review informed, modified Delphi consensus regarding prophylactic transfusions in neonates and children supported with extracorporeal membrane oxygenation (ECMO) from the Pediatric ECMO Anticoagulation CollaborativE. DATA SOURCES: A structured literature search was performed using PubMed, EMBASE, and Cochrane Library (CENTRAL) databases from January 1988 to May 2020, with an update in May 2021. STUDY SELECTION: Included studies assessed use of prophylactic blood product transfusion in pediatric ECMO. DATA EXTRACTION: Two authors reviewed all citations independently, with a third independent reviewer resolving conflicts. Thirty-three references were used for data extraction and informed recommendations. Evidence tables were constructed using a standardized data extraction form. MEASUREMENTS AND MAIN RESULTS: The evidence was evaluated using the Grading of Recommendations Assessment, Development and Evaluation system. Forty-eight experts met over 2 years to develop evidence-informed recommendations and, when evidence was lacking, expert-based consensus statements or good practice statements for prophylactic transfusion strategies for children supported with ECMO. A web-based modified Delphi process was used to build consensus via the Research And Development/University of California Appropriateness Method. Consensus was based on a modified Delphi process with agreement defined as greater than 80%. We developed two good practice statements, 4 weak recommendations, and three expert consensus statements. CONCLUSIONS: Despite the frequency with which pediatric ECMO patients are transfused, there is insufficient evidence to formulate evidence-based prophylactic transfusion strategies.

Comparison of the Quantra QPlus and ROTEM Goal-Directed Transfusion Protocols in Cardiothoracic Surgery Patients: A Prospective Observational Study.

OBJECTIVES: To compare the designed treatment protocols for the Quantra QPlus and rotational thromboelastometry (ROTEM) with regard to transfusion advice. DESIGN: Prospective observational study. SETTING: Maastricht University Medical Center, The Netherlands. PARTICIPANTS: Adults with elective cardiopulmonary bypass surgery with a ROTEM test. INTERVENTIONS: ROTEM tests were performed postoperatively for standard monitoring of coagulation status and clinical decision making. Simultaneously, a concurrent sample was analyzed for the Quantra QPlus. MEASUREMENTS AND MAIN RESULTS: A total of 100 samples were analyzed using both the ROTEM and Quantra QPlus. Agreement between the transfusion advice for the ROTEM and Quantra QPlus protocols were compared using Cohen κ values for i.a. fibrinogen, platelet concentrates, and fresh frozen plasma (FFP). The agreement between ROTEM and Quantra QPlus was poor for overall transfusion (0.174) and fibrinogen transfusion (0.300). The agreement of cutoff values for fibrinogen clot stiffness for the Quantra QPlus and EXTEM A10 for the ROTEM was poor (0.160). The fibrinogen clot stiffness and FIBTEM A10 had a moderate agreement (0.731). A Cohen κ could not be calculated for the agreement of protamine, thrombocytes, FFP or cutoff values for these transfusions since frequencies included zero in these cases. The Quantra QPlus transfusion protocol advises transfusion in many non-bleeders, adjustments appear to be necessary. In a small group of cases in which clinically relevant blood loss was observed, the Quantra QPlus advised administration of transfusion products, whereas the ROTEM tests did not. CONCLUSION: ROTEM-guided and Quantra-guided transfusion did not correspond in this patient group, and agreement was moderate at best. Specificity and sensitivity for transfusion within protocols were heterogeneous between the methods. More clinical research in high-bleeding risk populations is needed to determine the clinical impact of the different protocols.

A Contemporary Review of Blood Transfusion in Critically Ill Patients.

Blood transfusion is a common therapeutic intervention in hospitalized patients. There are numerous indications for transfusion, including anemia and coagulopathy with deficiency of single or multiple coagulation components such as platelets or coagulation factors. Nevertheless, the practice of transfusion in critically ill patients has been controversial mainly due to a lack of evidence and the need to consider the appropriate clinical context for transfusion. Further, transfusion carries many risk factors that must be balanced with benefits. Therefore, transfusion practice in ICU patients has constantly evolved, and we endeavor to present a contemporary review of transfusion practices in this population guided by clinical trials and expert guidelines.

Migration of di(2-ethylhexyl) phthalate, diisononylcyclohexane-1,2-dicarboxylate and di(2-ethylhexyl) terephthalate from transfusion medical devices in labile blood products: A comparative study.

BACKGROUND AND OBJECTIVES: Polyvinyl chloride (PVC) plasticized with di(2-ethylhexyl) phthalate (DEHP) is a widely used material for medical transfusion devices. Not covalently bound to PVC, DEHP can migrate into blood products during storage. Recognized as an endocrine disruptor and raising concerns about its potential carcinogenicity and reprotoxicity, DEHP is gradually being withdrawn from the medical device market. Therefore, the use of alternative plasticizers, such as diisononylcyclohexane-1,2-dicarboxylate (DINCH) and di(2-ethylhexyl) terephthalate (DEHT), as potential candidates for the replacement of DEHP in medical transfusion devices has been investigated. The purpose of this study was to evaluate the quantity of PVC-plasticizers in the blood components according to their preparation, storage conditions and in function of the plasticizer. MATERIALS AND METHODS: Whole blood was collected, and labile blood products (LBPs) were prepared by the buffy-coat method with a PVC blood bag plasticized either with DEHP, DINCH or DEHT. DINCH and DEHT equivalent concentrations were quantified in LBPs by liquid chromatography-tandem mass spectrometry or coupled with UV and compared to DEHP equivalent concentrations. RESULTS: The plasticizer equivalent concentration to which a patient is exposed during a transfusion depends on the preparation of LBPs as well as their storage conditions, that is, temperature and storage time. At day 1, for all LBPs, the migration of DEHP is 5.0 and 8.5 times greater than DINCH and DEHT, respectively. At the end of the 49 days storage period, the DEHP equivalent concentration in red blood cells concentrate is statistically higher when compared to DINCH and DEHT, with maximal values of 1.85, 1.13 and 0.86 µg/dm2 /mL, respectively. CONCLUSION: In addition to lower toxicity, transfused patients using PVC-DEHT or PVC-DINCH blood bags are less exposed to plasticizers than using PVC-DEHP bags with a ranging exposure reduction from 38.9% to 87.3%, due to lower leachability into blood components.

Risk of transfusion-transmitted hepatitis E virus infection from pool-tested platelets and plasma.

BACKGROUND AND AIMS: Immunocompromised patients are at risk of chronic hepatitis E which can be acquired by blood transfusions. Currently, screening of blood donors (BDs) for HEV RNA with a limit of detection (LOD) of 2,000 IU/ml is required in Germany. However, this may result in up to 440,000 IU of HEV RNA in blood products depending on their plasma volume. We studied the residual risk of transfusion-transmitted (tt) HEV infection when an LOD of 2,000 IU/ml is applied. METHODS: Highly sensitive individual donor testing for HEV RNA on the Grifols Procleix Panther system (LOD 7.89 IU/ml) was performed. HEV loads were quantified by real-time PCR. RESULTS: Of 16,236 donors, 31 (0.19%) were HEV RNA positive. Three BDs had viral loads between 710 and 2,000 IU/ml, which pose a significant risk of tt hepatitis E with any type of blood product. Eight BDs had viral loads of >32 to 710 IU/ml, which pose a risk of tt hepatitis E with platelet or plasma transfusions because of their higher plasma volume compared to red blood cell concentrates. Eight of these 11 potentially infectious BDs were seronegative for HEV, indicating a recent infection. Only 8 of 31 donors had viral loads >2,000 IU/ml that would also have been detected by the required screening procedure and 12 had very low HEV loads (<32 IU/ml). CONCLUSIONS: Screening of BDs with an LOD of 2,000 IU/ml reduced the risk of tt HEV infection by about 73% for red blood cell concentrates but by just 42% for platelet and fresh frozen plasma transfusions. Single donor screening (LOD <32 IU/ml) should lead to an almost 100% risk reduction. LAY SUMMARY: Immunocompromised patients, such as solid organ or hematopoietic stem cell recipients, are at risk of chronic hepatitis E, which can be acquired via blood transfusions. The risk of transfusion-transmitted hepatitis E in these patients may not be sufficiently controlled by (mini-)pool hepatitis E virus RNA screening of blood donors. Single donor screening should be considered to improve the safety of blood products.

Economic Evaluation of National Patient Blood Management Clinical Guidelines in Cardiac Surgery.

OBJECTIVES: To the best of our knowledge, no published clinical guidelines have ever undergone an economic evaluation to determine whether their implementation represented an efficient allocation of resources. Here, we perform an economic evaluation of national clinical guidelines designed to reduce unnecessary blood transfusions before, during, and after surgery published in 2012 by Australia's sole public blood provider, the National Blood Authority (NBA). METHODS: We performed a cost analysis from the government perspective, comparing the NBA's cost of implementing their perioperative patient blood management guidelines with the estimated resource savings in the years after publication. The impact on blood products, patient outcomes, and medication use were estimated for cardiac surgeries only using a large national registry. We adopted conservative counterfactual positions over a base-case 3-year time horizon with outcomes predicted from an interrupted time-series model controlling for differences in patient characteristics and hospitals. RESULTS: The estimated indexed cost of implementing the guidelines of A$1.5 million (2018-2019 financial year prices) was outweighed by the predicted blood products resource saving alone of A$5.1 million (95% confidence interval A$1.4 million-A$8.8 million) including savings of A$2.4 million, A$1.6 million, and A$1.2 million from reduced red blood cell, platelet, and fresh frozen plasma use, respectively. Estimated differences in patient outcomes were highly uncertain and estimated differences in medication were financially insignificant. CONCLUSIONS: Insofar as they led to a reduction in red blood cell, platelet, and fresh frozen plasma use during cardiac surgery, implementing the perioperative patient blood management guidelines represented an efficient use of the NBA's resources.

Pro-Con Debate: Viscoelastic Hemostatic Assays Should Replace Fixed Ratio Massive Transfusion Protocols in Trauma.

Major trauma patients at risk of traumatic coagulopathy are commonly treated with early clotting factor replacement to maintain hemostasis and prevent microvascular bleeding. In the United States, trauma transfusions are often dosed by empiric, low-ratio massive transfusion protocols, which pair plasma and platelets in some ratio relative to the red cells, such as the "1:1:1" combination of 1 units of red cells, 1 unit of plasma, and 1 donor's worth of pooled platelets. Empiric transfusion increases the rate of overtransfusion when unnecessary blood products are administered based on a formula and not on at patient's hemostatic profile. Viscoelastic hemostatic assays (VHAs) are point-of-care hemostatic assays that provided detailed information about abnormal clotting pathways. VHAs are used at many centers to better target hemostatic therapies in trauma. This Pro/Con section will address whether VHA guidance should replace empiric fixed ratio protocols in major trauma.

Improved stenosis outcome in stroke-free sickle cell anemia children after transplantation compared to chronic transfusion.

We report here the 3-year stenosis outcome in 60 stroke-free children with sickle cell anaemia (SCA) and an abnormal transcranial Doppler history, enrolled in the DREPAGREFFE trial, which compared stem cell transplantation (SCT) with standard-care (chronic transfusion for 1-year minimum). Twenty-eight patients with matched sibling donors were transplanted, while 32 remained on standard-care. Stenosis scores were calculated after performing cerebral/cervical 3D time-of-flight magnetic resonance angiography. Fourteen patients had stenosis at enrollment, but only five SCT versus 10 standard-care patients still had stenosis at 3 years. Stenosis scores remained stable on standard-care, but significantly improved after SCT (P = 0·006). No patient developed stenosis after SCT, while two on standard-care did, indicating better stenosis prevention and improved outcome after SCT.

Viral reduction of human blood by ultraviolet A-photosensitized vitamin K5.

Blood product transfusion can transmit viral pathogens. Pathogen reduction methods for blood products have been developed but, so far, are not available for whole blood. We evaluated if vitamin K5 (VK5) and ultraviolet A (UVA) irradiation could be used for virus inactivation in plasma and whole blood. Undiluted human plasma and whole blood diluted to 20% were spiked with high levels of vaccinia or Zika viruses. Infectious titers were measured by standard TCID50 assay before and after VK5/UVA treatments. Up to 3.6 log of vaccinia and 3.2 log of Zika were reduced in plasma by the combination of 500 µM VK5 and 3 J/cm2 UVA, and 3.1 log of vaccinia and 2.9 log of Zika were reduced in diluted human blood (20%) by the combination of 500 µM VK5 and 70 J/cm2 UVA. At end of whole blood treatment, hemolysis increased from 0.18% to 0.41% but remained below 1% hemolysis, which is acceptable to the Food and Drug Administration for red cell transfusion products. No significant alteration of biochemical parameters of red blood cells occurred with treatment. Our results provide proof of the concept that a viral pathogen reduction method based on VK5/UVA may be developed for whole blood.

Risk analysis of transfusion of cryoprecipitate without consideration of ABO group.

BACKGROUND: Transfusion medicine standards in Canada state that adult recipients can be transfused with cryoprecipitate of any ABO group, however, not all hospitals follow this guideline. There is a paucity of data on cryoprecipitate anti-A/B levels to reinforce standards. STUDY DESIGN AND METHODS: Manual tube antibody titration was performed on 7 units of group O plasma and the corresponding cryosupernatant plasma and cryoprecipitate. IgG/IgM levels were determined by nephelometry. Additionally, 10 cryoprecipitate each from groups A, B, and O were similarly assessed. From the antibody titer distribution among these samples, the probability of making a pool of cryoprecipitate with a titer ≥1:100 was calculated using bootstrap analysis. RESULTS: Anti-A/B titers in cryoprecipitate were equivalent to those in corresponding plasma; partitioning of anti-A/B activity into cryoprecipitate was not observed. Average IgM concentration was higher in cryoprecipitate than in plasma (P < .01). However, no correlation between IgM levels and anti-A/B titers was established. Among 30 cryoprecipitates from routine blood bank inventory, the median antibody titer and mode were 1:32 and 1:16, respectively. Of the samples tested, 4 of 30 and 9 of 30 had titers above 1:100 and 1:50, respectively. The probability of transfusing an adult dose of cryoprecipitate (pool of 10 cryoprecipitate) with a titer higher than 1:100 was calculated to be less than 1 in 3 million. CONCLUSIONS: This study provides strong evidence to support current Canadian transfusion medicine standards on the safety of transfusion of cryoprecipitate without the need for blood group matching in adult recipients.

HIV transmission network analysis allows identifying unreported risk factors in HIV-positive blood donors in France.

OBJECTIVES: As sex between men is a major route of human immunodeficiency virus (HIV) infection in most western countries, restrictive deferral rules for blood donation have largely been implemented regarding men having sex with men (MSM). Here, we sought here to assign unreported HIV risk factors in blood donors (BDs) and reevaluated the MSM-associated fraction of HIV transfusion residual risk (%RRMSM ). METHODS: We applied a genetic distance-based approach to infer an HIV transmission network for 384 HIV sequences from French BDs and 1337 HIV sequences from individuals with known risk factors (ANRS PRIMO primary HIV infection cohort). We validated the possibility of assigning a risk factor according to clustering using assortative mixing. Finally, we recalculated the %RRMSM . RESULTS: A total of 81 of 284 (28.5%) male and 5 of 100 (5%) female BDs belonged to a cluster; 72 (88.9%) of the 81 male BDs belonged to MSM clusters. After cluster correction, 8 of 67 (11.9%), 4 of 21 (19.0%), and 19 of 88 (21.6%) HIV-positive (HIV+) male BDs with heterosexual, other, or unknown risk factors could be reclassified as MSM, accounting for 10.9% of the total HIV+ male BDs. Overall, 139 of 284 HIV+ male donors (48.9%) could be considered MSM between 2000 and 2016 in France. Between 2005 and 2016, the %RRMSM increase varied from 0 to 19%, without differing significantly from the %RRMSM before reclassification. CONCLUSION: Network inference can be used to complement declaration data on risk factors for HIV infection in BDs. This approach, complementary to behavioral studies, is a valuable tool to evaluate the effect of changes in deferral criteria on BD compliance.

New HIV infections from blood transfusions averted in 28 countries supported by PEPFAR blood safety programs, 2004-2015.

BACKGROUND: To quantify the impact of the US President's Emergency Plan for AIDS Relief (PEPFAR) on the risk of HIV transmission through infected blood donations in countries supported by PEPFAR blood safety programs. METHODS: Data reported to the World Health Organization Global Database on Blood Safety were analyzed from 28 countries in sub-Saharan Africa (SSA), Asia, and the Caribbean during 2004-2015. We used the Goals model of Spectrum Spectrum System Software, version 5.53, to perform the modeling, assuming laboratory quality for HIV testing had 91.9% sensitivity and 97.7% specificity irrespective of testing method based on results of two external quality assurance and proficiency testing studies of transfusion screening for HIV in SSA blood centers. We calculated the number of new HIV infections from the number of transfusions and the prevalence of HIV infection acquired from blood transfusions with infected blood donations. We determined the impact of laboratory testing programs by estimating the number of new HIV infections averted since PEPFAR implementation. RESULTS: Assuming that HIV testing would not be performed in any of these countries without PEPFAR funding, the number of new HIV infections acquired from blood transfusions averted by laboratory testing increased over time in all 28 countries. The total number of HIV infections averted was estimated at 229 278 out of 20 428 373 blood transfusions during 2004-2015. CONCLUSION: Our mathematical modeling suggests a positive impact achieved over 12 years of PEPFAR support for blood safety. Standardized HIV testing of donated blood has reduced the risk of HIV transmission through blood transfusions in SSA, Asia, and the Caribbean.

Blood Donation and COVID-19: Reconsidering the 3-Month Deferral Policy for Gay, Bisexual, Transgender, and Other Men Who Have Sex With Men.

In April 2020, in light of COVID-19-related blood shortages, the US Food and Drug Administration (FDA) reduced the deferral period for men who have sex with men (MSM) from its previous duration of 1 year to 3 months.Although originally born out of necessity, the decades-old restrictions on MSM donors have been mitigated by significant advancements in HIV screening, treatment, and public education. The severity of the ongoing COVID-19 pandemic-and the urgent need for safe blood products to respond to such crises-demands an immediate reconsideration of the 3-month deferral policy for MSM.We review historical HIV testing and transmission evidence, discuss the ethical ramifications of the current deferral period, and examine the issue of noncompliance with donor deferral rules. We also propose an eligibility screening format that involves an individual risk-based screening protocol and, unlike current FDA guidelines, does not effectively exclude donors on the basis of gender identity or sexual orientation. Our policy proposal would allow historically marginalized community members to participate with dignity in the blood donation process without compromising blood donation and transfusion safety outcomes.