Publications by authors named "Louis Katz"

56 Publications

Impact of the early COVID-19 pandemic on blood utilization in the United States: a time-series analysis of data reported to the National Healthcare Safety Network Hemovigilance Module.

Transfusion 2021 May 14. Epub 2021 May 14.

Division of Healthcare Quality Promotion, Centers for Disease Control and Prevention.

Introduction: The coronavirus disease 2019 (COVID-19) pandemic has disrupted healthcare services worldwide. However, little has been reported regarding the impact on blood utilization. We quantified the impact of COVID-19 on blood utilization and discards among facilities reporting to the National Healthcare Safety Network Hemovigilance Module.

Methods: Facilities continuously reporting data, during January 2016-June 2020, on transfused and discarded blood components, stratified by component type (red blood cells [RBC], platelets and plasma), were included. Interrupted time-series analysis with generalized estimating equations, adjusting for facility surgical volume and seasonality, was used to quantify changes in blood utilization and discards relative to a Centers for Medicare & Medicaid Services notification delaying non-essential medical procedures (March 2020).

Results: Seventy-two facilities included in the analyses, on average, transfused 44,548 and discarded 2202 blood components monthly. Following the March 2020 notification and after multivariable adjustment, RBC and platelet utilization declined, -14.8% (p < 0.001) and - 16.6% (p = 0.017) respectively. Discards increased for RBCs (49.0%, p = 0.013) and platelets (60.4%, p = 0.002). No statistically significant change in plasma was found. Following these abrupt changes, blood utilization and discards rebounded towards baseline with RBC use increasing by 5.7% (p < 0.001), and platelet and RBC discards decreasing -16.4% (<0.001) and - 12.7 (p = 0.001), respectively.

Conclusion: Following notification delaying elective surgical procedures, blood utilization declined substantially while blood discards increased, resulting in substantial wastage of blood products. Ongoing and future pandemic response efforts should consider the impact of interventions on blood supply and demand to ensure blood availability. This article is protected by copyright. All rights reserved.
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http://dx.doi.org/10.1111/trf.16451DOI Listing
May 2021

(A Little) Clarity on Convalescent Plasma for Covid-19.

Authors:
Louis M Katz

N Engl J Med 2021 02 13;384(7):666-668. Epub 2021 Jan 13.

From the Mississippi Valley Regional Blood Center, Davenport, IA.

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http://dx.doi.org/10.1056/NEJMe2035678DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7821982PMC
February 2021

Buffy coat platelets coming to America: Are we ready?

Transfusion 2021 Feb 10;61(2):627-633. Epub 2020 Nov 10.

Macopharma USA, Duluth, Georgia.

Background: Buffy coat (BC) platelets (PLTs) have been used globally for many years. In 2004 Canadian Blood Services (CBS) made the decision to transition from PLT-rich plasma (PRP) to BC PLTs. We reviewed the benefits and manufacture process of BC and the implementation challenges involved.

Study Design And Methods: A literature review was performed in the following areas: BC efficacy, donor population shifts, production and good stewardship of PLTs, logistic considerations with overnight holds, advantages of the overnight hold, the CBS experience, licensure and standards, and changes needed to produce BC PLTs in the United States. The aim was to analyze current practice and identify possible actions for blood centers and hospitals.

Results: Implementation of BC would offer an additional source of PLTs to address the growing elderly population and the declining apheresis donor base. Substantial logistic, operational, and financial benefits were seen when CBS transitioned to BC with overnight hold.

Conclusions: Buffy coat blood products are widely used throughout the world. Recent conversion from PRP to BC by CBS showed that conversion can be accomplished with planning, communication, and partnership from all stakeholders. In conclusion, BC PLTs are worth serious consideration in the United States, but regulatory barriers in the United States will need to be addressed.
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http://dx.doi.org/10.1111/trf.16184DOI Listing
February 2021

Comparative changes of pre-operative autologous transfusions and peri-operative cell salvage in the United States.

Transfusion 2020 Oct 31;60(10):2260-2271. Epub 2020 Aug 31.

Department of Pathology, Johns Hopkins Hospital, Baltimore, Maryland, USA.

Background: With improved safety of allogeneic blood supply, the use of preoperative autologous donations (PADs) and perioperative autologous cell salvage (PACS) has evolved. This study evaluated temporal trends in PAD and PACS use in the United States.

Methods: The National Inpatient Sample database, a stratified probability sample of 20% of hospitalizations in the United States, was used to compare temporal trends in hospitalizations reporting use of PADs and PACS from 1995 to 2015. Factors associated with their use were examined between 2012 and 2015 with use of multivariable Poisson regression. Sampling weights were applied to generate nationally representative estimates.

Results: There was a steady decrease in hospitalizations reporting PAD transfusions from 27.90 per 100 000 in 1995 to 1.48 per 100 000 hospitalizations in 2015 (P-trend <.001). In contrast, PACS increased from a rate of 1.16 per 100 000 in 1995 to peak of 20.51 per 100 000 hospitalizations in 2008 and then steadily declined (P-trend<.001). Higher odds of PACS and PADs were observed in older patients, elective procedures (vs urgent), and urban teaching/nonteaching hospitals (vs rural hospitals) (P < .001). PACS was more common in hospitalizations in patients with higher levels of severity of illness as compared to those with minor severity (adjusted prevalence ratio [adjPR], 2.39; 95% confidence interval [CI], 2.08-2.73; P<.001), while PADs were performed less often in patients with higher underlying severity of illness (All Patient Refined Diagnosis Related Groups, 4 vs 1, adjPR, 0.61; 95% CI, [0.39-0.95]; P = .028).

Conclusions: There was a significant decrease in PAD red blood cell transfusions, while PACS has increased and subsequently decreased; PACS plays an important role in surgical blood conservation. The subsequent decline in PACS likely reflects further optimization of transfusion practice through patient blood management programs and improvement of surgical interventions.
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http://dx.doi.org/10.1111/trf.15949DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7902373PMC
October 2020

Rapid establishment of a COVID-19 convalescent plasma program in a regional health care delivery network.

Transfusion 2020 10 21;60(10):2203-2209. Epub 2020 Aug 21.

Mississippi Valley Regional Blood Center, Springfield, Illinois, USA.

Background: COVID-19 convalescent plasma (CCP) represents an appealing approach to the treatment of patients with infections due to SARS-CoV-2. We endeavored to quickly establish a sustainable CCP transfusion program for a regional network of health care facilities.

Study Design And Methods: A regional collaborative group was activated to address the issues necessary to implementing a CCP transfusion program and making the program sustainable. A wide range of health care providers including physicians (critical care, infectious disease, transfusion medicine), nurses, pharmacists, laboratorians, and information technology (IT) specialists were required to make the program a success.

Results: The CCP implementation team initially consisted of four members but quickly grew to a group of nearly 20 participants based on different issues related to program implementation. Overall, six major implementation "themes" were addressed: (a) registration of individual hospitals and principal investigators with a national investigational new drug research protocol; (b) collaboration with a regional blood donor center; (c) targeted recruitment of convalesced donors; (d) IT issues related to all aspects of CCP ordering, distribution, and transfusion; (e) prioritization of patients to receive CCP; and (f) evaluation of CCP products including antibody characteristics and patient response to therapy.

Conclusion: Within 4 weeks of initiation, CCP was successfully transfused at multiple hospitals in our regional health care delivery system. A program infrastructure was established that will make this program sustainable into the future. This approach has broader implications for the success of multi-institutional programs requiring rapid implementation.
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http://dx.doi.org/10.1111/trf.16026DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7436587PMC
October 2020

Evaluation of donor informed consents and associated predonation educational materials in the United States and Canada: variability in elements of consent and measures of readability and reading burden.

Transfusion 2020 08 4;60(8):1747-1755. Epub 2020 Jul 4.

Mississippi Valley Regional Blood Center, Davenport, Iowa, USA.

Background: Every day, approximately 30,000 donors present to blood collection establishments in the United States or Canada, where they are provided information about donation and asked to sign a consent before donating. We evaluated elements of informational and consent documents and measures of readability that may influence their comprehension.

Materials And Methods: Consents for whole blood (WB) and automated collections and predonation reading materials (PRMs) representing over 93% of WB collections in the United States and Canada were evaluated. Elements, including risks of donation, were cataloged. Word count, Flesch-Kinkaid (F-K) reading ease/grade level scores, Simple Measure of Gobbledygook grade, and percentage of complex words were measured.

Results: F-K grade levels ranged from 9.2 to 16.9 for WB consents, 7.8 to 16.0 for apheresis consents, and 6.7 to 10.9 for PRMs, above the recommended level of eighth grade or lower for general audiences. F-K reading ease scores were below the cutoff of 60 for readability. Reading burden was substantial, with word count ranging from 131 to 885, 131 to 996, and 649 to 2743 for WB and apheresis consents and PRMs, respectively. Use of jargon and the absence of consent elements such as confidentiality, voluntariness, ability to withdraw consent, and risks of deferral were common.

Conclusions: Donor consent documents and associated materials vary widely, are written at challenging grade levels, present considerable reading burden, contain substantial jargon, and are missing key elements of consent. The authors recommend an organized effort, including blood donors, legal experts, and blood collection experts, to reach consensus on the minimal requirements for standardized clear and concise consent documents in an optimized format.
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http://dx.doi.org/10.1111/trf.15867DOI Listing
August 2020

Individual- and hospital-level correlates of red blood cell, platelet, and plasma transfusions among hospitalized children and neonates: a nationally representative study in the United States.

Transfusion 2020 08 26;60(8):1700-1712. Epub 2020 Jun 26.

Department of Pathology, Johns Hopkins Hospital, Baltimore, Maryland, USA.

Background: Factors associated with red blood cell (RBC), plasma, and platelet transfusions in hospitalized neonates and children across the United States have not been well characterized.

Methods: Data from the Kids' Inpatient Database (KID) 2016 were analyzed. KID is a random sample of 10% of all uncomplicated in-hospital births and 80% of remaining pediatric discharges from approximately 4200 US hospitals. Sampling weights were applied to generate nationally representative estimates. Primary outcome was one or more RBC transfusion procedures; plasma and platelet transfusions were assessed as secondary outcomes. Analysis was stratified by age: neonates (NEO; ≤28 d), and nonneonates (PED; >28 d and <18 y). Multivariable logistic regression was used to estimate adjusted odds ratios (aORs) and 95% confidence intervals (95% CIs).

Results: Among 5,604,984 total hospitalizations, overall prevalence of transfusions was 1.07% (95% CI, 0.94%-1.22%) for RBCs, 0.17% (95% CIs, 0.15%-0.21%) for plasma and 0.35% (95% CI, 0.30%-0.40%) for platelet transfusions. RBC transfusions occurred among 0.43% NEO admissions and 2.63% PED admissions. For NEO admissions, RBC transfusion was positively associated with nonwhite race, longer length of hospitalization, highest risk of mortality (aOR, 86.58; 95% CI, 64.77-115.73) and urban teaching hospital location. In addition to the above factors, among PED admissions, RBC transfusion was positively associated with older age, female sex (aOR, 1.10; 95% CI, 1.07-1.13), and elective admission status (aOR, 1.62; 95% CI, 1.46-1.80). Factors associated with plasma and platelet transfusions were largely similar to those associated with RBC transfusion, except older age groups had lower odds of plasma transfusion among PED admissions.

Conclusions: While there is substantial variability in the proportion of neonates and nonneonatal children transfused nationally, there are several similar, yet unique, nonlaboratory predictors of transfusion identified in these age groups.
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http://dx.doi.org/10.1111/trf.15855DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7951993PMC
August 2020

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

Transfusion 2020 08 20;60(8):1756-1764. Epub 2020 Jun 20.

Mississippi Valley Regional Blood Center, Davenport, Iowa, USA.

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.
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http://dx.doi.org/10.1111/trf.15866DOI Listing
August 2020

Is SARS-CoV-2 transfusion transmitted?

Authors:
Louis M Katz

Transfusion 2020 06;60(6):1111-1114

Mississippi Valley Regional Blood Center, Davenport, IA, USA.

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http://dx.doi.org/10.1111/trf.15831DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7323094PMC
June 2020

Financial analysis of large-volume delayed sampling to reduce bacterial contamination of platelets.

Transfusion 2020 05 10;60(5):997-1002. Epub 2020 Apr 10.

Transfusion Medicine Division, Department of Pathology, Johns Hopkins University, Baltimore, Maryland, USA.

Background: Effective and financially viable mitigation approaches are needed to reduce bacterial contamination of platelets in the US. Expected costs of large-volume delayed sampling (LVDS), which would be performed by a blood center prior to shipment to a hospital, were compared to those of pathogen reduction (PR), point-of-release testing (PORt), and secondary bacterial culture (SBC).

Methods: Using a Markov-based decision-tree model, the financial and clinical impact of implementing all variants of LVDS, PR, PORt, and SBC described in FDA guidance were evaluated from a hospital perspective. Hospitals were assumed to acquire leukoreduced apheresis platelets, with LVDS adding $30 per unit. Monte Carlo simulations were run to estimate the direct medical costs for platelet acquisition, testing, transfusion, and possible complications associated with each approach. Input parameters, including test sensitivity and specificity, were drawn from existing literature and costs (2018US$) were based on a hospital perspective. A one-way sensitivity analysis varied the assumed additional cost of LVDS.

Results: Under an approach of LVDS (7-day), the total cost per transfused unit is $735.78, which falls between estimates for SBC (7-day) and PORt. Assuming 20,000 transfusions each year, LVDS would cost $14.72 million annually. Per-unit LVDS costs would need to be less than $22.32 to be cheaper per transfusion than all other strategies, less than $32.02 to be cheaper than SBC (7-day), and less than $196.19 to be cheaper than PR (5-day).

Conclusions: LVDS is an effective and cost-competitive approach, assuming additional costs to blood centers and associated charges to hospitals are modest.
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http://dx.doi.org/10.1111/trf.15773DOI Listing
May 2020

Deployment of convalescent plasma for the prevention and treatment of COVID-19.

J Clin Invest 2020 06;130(6):2757-2765

Division of Transfusion Medicine, Department of Pathology.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the cause of coronavirus disease 2019 (COVID-19), has spurred a global health crisis. To date, there are no proven options for prophylaxis for those who have been exposed to SARS-CoV-2, nor therapy for those who develop COVID-19. Immune (i.e., "convalescent") plasma refers to plasma that is collected from individuals following resolution of infection and development of antibodies. Passive antibody administration through transfusion of convalescent plasma may offer the only short-term strategy for conferring immediate immunity to susceptible individuals. There are numerous examples in which convalescent plasma has been used successfully as postexposure prophylaxis and/or treatment of infectious diseases, including other outbreaks of coronaviruses (e.g., SARS-1, Middle East respiratory syndrome [MERS]). Convalescent plasma has also been used in the COVID-19 pandemic; limited data from China suggest clinical benefit, including radiological resolution, reduction in viral loads, and improved survival. Globally, blood centers have robust infrastructure for undertaking collections and constructing inventories of convalescent plasma to meet the growing demand. Nonetheless, there are nuanced challenges, both regulatory and logistical, spanning donor eligibility, donor recruitment, collections, and transfusion itself. Data from rigorously controlled clinical trials of convalescent plasma are also few, underscoring the need to evaluate its use objectively for a range of indications (e.g., prevention vs. treatment) and patient populations (e.g., age, comorbid disease). We provide an overview of convalescent plasma, including evidence of benefit, regulatory considerations, logistical work flow, and proposed clinical trials, as scale-up is brought underway to mobilize this critical resource.
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http://dx.doi.org/10.1172/JCI138745DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7259988PMC
June 2020

It's time to phase out "serologic weak D phenotype" and resolve D types with RHD genotyping including weak D type 4.

Transfusion 2020 04 12;60(4):855-859. Epub 2020 Mar 12.

Department of Pathology and Laboratory Medicine, MedStar Georgetown University Hospital, Washington, DC, USA.

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http://dx.doi.org/10.1111/trf.15741DOI Listing
April 2020

Frequent blood donation and offspring birth weight-a next-generation association?

Transfusion 2019 03 5;59(3):995-1001. Epub 2018 Dec 5.

Department of Clinical Immunology, Copenhagen University Hospital, Copenhagen, Denmark.

Background: The prevalence of iron depletion is high among premenopausal women who donate blood frequently. Studies in nondonor populations indicate that iron deficiency anemia is associated with an increased risk of low birth weight. This prompts concerns that iron deficiency induced by frequent blood donation might impair subsequent fetal development.

Study Design And Methods: The aim of this study was to assess whether prepregnancy donation intensity affects the birth weight of singletons born at term (gestational week 38 or later) to nulliparous female donors in Denmark. We identified 293,897 first live singleton births to Danish women between 1997 and 2012 with complete information on gestational age, birth weight, child sex, parental age, maternal smoking status during pregnancy, and parental education length and annual income. Linear regression analysis was applied, with birth weight as outcome, number of donations within the 3 years before pregnancy as the explanatory variable, and confounding variables as described.

Results: Birth weight among children of low-intensity donors (n = 22,120) was 12.6 g (95% confidence interval, 6.7-18.6) higher than nondonors (n = 268,253) after controlling for the above-mentioned factors. The higher birth weight among low-intensity donors can be explained by the healthy donor effect. In fully adjusted analyses, birth weight among children of high-intensity donors (n = 3,524) was 20.2 g (95% confidence interval, 5.1-35.3 g) lower compared with low-intensity donors. This reduced birth weight among high-intensity donors compared to low-intensity donors may reflect blood donation-induced iron deficiency.

Conclusions: Our results show that high prepregnancy donation intensity is inversely associated with birth weight of singletons born at term to nulliparous women.
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http://dx.doi.org/10.1111/trf.15072DOI Listing
March 2019

Report of a workshop on ensuring sustainable access to safe blood in developing countries: International Blood Safety Forum, March 24, 2017.

Transfusion 2018 05 14;58(5):1299-1306. Epub 2018 Mar 14.

American Association of Blood Banks, Division of Consulting and Global Services, Washington, DC.

On March 24, 2017, more than 90 experts in blood safety and international development from blood centers, industry, government, and international and nongovernmental organizations gathered in Arlington, Virginia, for the Third International Blood Safety Forum, cosponsored by America's Blood Centers and Global Healing. This report summarizes presentations and major conclusions. The meeting explored ways to increase access to affordable, safe blood for low- and lower-middle-income countries (LMICs) in an era when funding from the US President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund has been redirected from preventing the spread of human immunodeficiency virus (HIV) to diagnosing and treating the 25 million-plus people living with HIV in LMICs. More effective management systems must be developed to improve cost recovery for blood. While blood systems become more sustainable, continued investment is required to keep them operating. The traditional model of large grants from bilateral and multilateral donors will need to be supplemented (or replaced) with public-private partnerships and nongovernmental investment. A continued emphasis on quality is fundamental. Blood systems must build quality programs, based on accepted standards, including hospitals, clinics, and rural health care providers to ensure proper and safe use of blood. Proposals to resolve health care inequities between LMICs and high-income countries (HICs) must include helping LMICs to define sustainable national policies and practices for blood availability and utilization to suit local contexts. The blood safety lexicon should be revised to include availability, accessibility, and affordability of safe blood and blood products as the goal of all blood safety initiatives.
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http://dx.doi.org/10.1111/trf.14591DOI Listing
May 2018

The cobas® 6800/8800 System: a new era of automation in molecular diagnostics.

Expert Rev Mol Diagn 2017 02;17(2):167-180

a Roche Molecular Systems Inc ., Pleasanton , CA , USA.

Introduction: Molecular diagnostics is a key component of laboratory medicine. Here, the authors review key triggers of ever-increasing automation in nucleic acid amplification testing (NAAT) with a focus on specific automated Polymerase Chain Reaction (PCR) testing and platforms such as the recently launched cobas® 6800 and cobas® 8800 Systems. The benefits of such automation for different stakeholders including patients, clinicians, laboratory personnel, hospital administrators, payers, and manufacturers are described. Areas Covered: The authors describe how molecular diagnostics has achieved total laboratory automation over time, rivaling clinical chemistry to significantly improve testing efficiency. Finally, the authors discuss how advances in automation decrease the development time for new tests enabling clinicians to more readily provide test results. Expert Commentary: The advancements described enable complete diagnostic solutions whereby specific test results can be combined with relevant patient data sets to allow healthcare providers to deliver comprehensive clinical recommendations in multiple fields ranging from infectious disease to outbreak management and blood safety solutions.
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http://dx.doi.org/10.1080/14737159.2017.1275962DOI Listing
February 2017

Zika and the Blood Supply: A Work in Progress.

Arch Pathol Lab Med 2017 Jan 27;141(1):85-92. Epub 2016 Oct 27.

From America's Blood Centers, Washington DC, and the Department of Medicine, Division of Infectious Diseases, Roy J. and Lucille A. Carver College of Medicine, Iowa City, Iowa (Dr Katz); and the Gulf Coast Regional Blood Center, Houston, Texas (Dr Rossmann).

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.
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http://dx.doi.org/10.5858/arpa.2016-0430-RADOI Listing
January 2017

Clinical Practice Guidelines From the AABB: Red Blood Cell Transfusion Thresholds and Storage.

JAMA 2016 Nov;316(19):2025-2035

Department of Pathology, Johns Hopkins University School of Medicine, Baltimore, Maryland.

Importance: More than 100 million units of blood are collected worldwide each year, yet the indication for red blood cell (RBC) transfusion and the optimal length of RBC storage prior to transfusion are uncertain.

Objective: To provide recommendations for the target hemoglobin level for RBC transfusion among hospitalized adult patients who are hemodynamically stable and the length of time RBCs should be stored prior to transfusion.

Evidence Review: Reference librarians conducted a literature search for randomized clinical trials (RCTs) evaluating hemoglobin thresholds for RBC transfusion (1950-May 2016) and RBC storage duration (1948-May 2016) without language restrictions. The results were summarized using the Grading of Recommendations Assessment, Development and Evaluation method. For RBC transfusion thresholds, 31 RCTs included 12 587 participants and compared restrictive thresholds (transfusion not indicated until the hemoglobin level is 7-8 g/dL) with liberal thresholds (transfusion not indicated until the hemoglobin level is 9-10 g/dL). The summary estimates across trials demonstrated that restrictive RBC transfusion thresholds were not associated with higher rates of adverse clinical outcomes, including 30-day mortality, myocardial infarction, cerebrovascular accident, rebleeding, pneumonia, or thromboembolism. For RBC storage duration, 13 RCTs included 5515 participants randomly allocated to receive fresher blood or standard-issue blood. These RCTs demonstrated that fresher blood did not improve clinical outcomes.

Findings: It is good practice to consider the hemoglobin level, the overall clinical context, patient preferences, and alternative therapies when making transfusion decisions regarding an individual patient. Recommendation 1: a restrictive RBC transfusion threshold in which the transfusion is not indicated until the hemoglobin level is 7 g/dL is recommended for hospitalized adult patients who are hemodynamically stable, including critically ill patients, rather than when the hemoglobin level is 10 g/dL (strong recommendation, moderate quality evidence). A restrictive RBC transfusion threshold of 8 g/dL is recommended for patients undergoing orthopedic surgery, cardiac surgery, and those with preexisting cardiovascular disease (strong recommendation, moderate quality evidence). The restrictive transfusion threshold of 7 g/dL is likely comparable with 8 g/dL, but RCT evidence is not available for all patient categories. These recommendations do not apply to patients with acute coronary syndrome, severe thrombocytopenia (patients treated for hematological or oncological reasons who are at risk of bleeding), and chronic transfusion-dependent anemia (not recommended due to insufficient evidence). Recommendation 2: patients, including neonates, should receive RBC units selected at any point within their licensed dating period (standard issue) rather than limiting patients to transfusion of only fresh (storage length: <10 days) RBC units (strong recommendation, moderate quality evidence).

Conclusions And Relevance: Research in RBC transfusion medicine has significantly advanced the science in recent years and provides high-quality evidence to inform guidelines. A restrictive transfusion threshold is safe in most clinical settings and the current blood banking practices of using standard-issue blood should be continued.
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http://dx.doi.org/10.1001/jama.2016.9185DOI Listing
November 2016

The association between frequency of blood donation and the occurrence of low birthweight, preterm delivery, and stillbirth: a retrospective cohort study.

Transfusion 2016 11 11;56(11):2760-2767. Epub 2016 Aug 11.

Medical Affairs, Héma-Québec, Montréal, Québec, Canada.

Background: Women who donate blood on a regular basis are at high risk of becoming iron depleted. Iron deficiency anemia has been shown to increase the risk of low birthweight and possibly preterm birth. Therefore, there is a concern that regular blood donation by female donors might adversely impact the well-being of their offspring. This retrospective cohort study examined the association between blood donation and the occurrence of adverse pregnancy outcomes.

Study Design And Methods: The study sample included 18,483 female blood donors in their childbearing years (age 18 to 45 years) who delivered during the period 2001 to 2011 in the province of Québec (Canada). The occurrence of low birthweight (<2500 g), preterm delivery (<37 weeks of gestation), and stillbirth was ascertained by linking the donor information with provincial birth and stillbirth registries.

Results: There was no association between the frequency of donation in the 2-year period before pregnancy and adverse pregnancy outcomes; compared to women who did not donate during that period, those who donated three or more donations (mean, 3.9 donations) had a relative risk of 0.83 (95% confidence interval [CI], 0.65-1.06) for low birthweight, 0.91 (95% CI, 0.75-1.11) for preterm birth, and 0.62 (95% CI, 0.18-2.12) for stillbirth. These associations remained unchanged after adjusting for baseline characteristics.

Conclusion: Women who donate blood on a regular but moderate basis do not appear to be at higher risk of adverse pregnancy outcomes. These findings, while reassuring, will need to be replicated in different settings.
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http://dx.doi.org/10.1111/trf.13762DOI Listing
November 2016

Qui custodiet ipsos custodes?

Transfusion 2015 Apr 11;55(4):693-5. Epub 2015 Feb 11.

America's Blood Centers, Washington, DC.

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http://dx.doi.org/10.1111/trf.13023DOI Listing
April 2015

Ebola virus disease, transmission risk to laboratory personnel, and pretransfusion testing.

Transfusion 2014 Dec 18;54(12):3247-51. Epub 2014 Nov 18.

America's Blood Centers, Washington, DC; Internal Medicine, Infectious Diseases, Carver College of Medicine, University of Iowa, Iowa City, IA.

As Ebola virus has infected thousands of individuals in West Africa, there is growing concern about the appropriate response of hospitals in developed nations caring for patients and handling laboratory specimens for patients suspected of Ebola virus disease (EVD). Guidelines for caring for EVD patients are proliferating rapidly from national and state public health authorities, professional societies, and individual hospitals. It is no surprise that they differ from one another, and some very conservative recommendations call for suspension of routine laboratory testing, including pretransfusion testing. EVD is transmitted by direct contact with blood, secretions, organs, and other body fluids and not by airborne routes. Based on experimental and observational data, the US Centers for Disease Control and Prevention (CDC) recommends that clinicians follow contact and droplet precautions. Laboratory personnel are required to follow the blood-borne pathogen standard, especially the use of appropriate barriers consisting of gloves, gown, goggles, mask to cover nose and mouth, and plexiglass shield, where splashes of potentially infectious materials may be generated. Their recommendations are permissive of clinically appropriate laboratory testing, including pretransfusion testing, using barrier isolation precautions. Most individuals with suspected EVD will have a fever of another etiology, such as Plasmodium falciparum malaria. We believe that forgoing all routine pretransfusion laboratory testing may result in a greater increase in poor clinical outcomes than any diminution in the risks to laboratory personnel will justify. It is imperative for all laboratory directors, working with institutional infection control and safety personnel, to evaluate their hospital policies for potentially infectious patients and provide a safe environment for their patients and employees.
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http://dx.doi.org/10.1111/trf.12913DOI Listing
December 2014

Screening for babesiosis: where is the policy?

Transfusion 2014 Sep;54(9):2154-6

America's Blood Centers, Washington DC; Carver College of Medicine Division of Infectious Diseases Iowa City, IA.

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http://dx.doi.org/10.1111/trf.12807DOI Listing
September 2014

Emerging microbial threats to the United States blood supply.

Authors:
Louis M Katz

Curr Opin Hematol 2014 Nov;21(6):509-14

America's Blood Centers, Washington, DC, USA.

Purpose Of Review: In this short review, several emerging agents are described to demonstrate potential responses of the blood community to emerging and potentially emerging infections.

Recent Findings: Critical questions are raised as we consider appropriate approaches to these agents. Can we identify risk thresholds below which interventions are not required, that is, are there tolerable infectious risks of transfusion? Who are the stakeholders responsible for that determination? What is the role of health economic analysis for informing those decisions? If we decide that cost-utility thresholds for transfusion medicine are appropriately several fold higher than for the rest of clinical medicine, who has responsibility for being certain whether those priorities are funded?

Summary: Four agents will be discussed to highlight the evolving considerations in response to these considerations.
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http://dx.doi.org/10.1097/MOH.0000000000000089DOI Listing
November 2014

How safe is safe enough, who decides and how? From a zero-risk paradigm to risk-based decision making.

Transfusion 2014 Mar;54(3 Pt 2):753-7

Community Blood Center (Kansas City), Kansas City, Missouri.

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http://dx.doi.org/10.1111/trf.12569DOI Listing
March 2014

Survey of methods used to detect bacterial contamination of platelet products in the United States in 2011.

Transfusion 2013 Apr 5;53(4):911-8. Epub 2013 Mar 5.

Laboratory Corporation of America, Burlington, North Carolina; Case Western Reserve University, Cleveland, Ohio, USA.

Background: Testing of platelets (PLTs) for bacterial contamination is required by the AABB Standards but is not fully standardized. On January 31, 2011, a new AABB Standard, 5.1.5.1.1, specified that bacterial detection methods for PLT components shall use assays either approved by the Food and Drug Administration (FDA) or validated to provide sensitivity equivalent to these FDA-approved methods.

Methods: An Internet-based survey of AABB member institutions was conducted from May to June 2012, to document current practices used in 2011 for bacterial detection in different PLT products and to assess the impact of the new standard.

Results: Of 1053 AABB member institutions surveyed, 40 of 99 blood centers (40.4%) and 184 of 954 hospital blood banks or transfusion services (19.3%) responded. Sixty-four respondents manufactured PLTs. Apheresis PLTs (APs) were predominantly screened with the BacT/ALERT system (89.5%); the majority (95.2%) were cultured with at least 8 mL of product. There was substantial variation in the minimum incubation time of cultures before release of PLTs (range, 0 to >24 hr). Recalls of released AP for possible bacterial contamination were largely successful (67.3%); successful interdiction before transfusion was associated with incubation for more than 12 hours before release (p < 0.01). After Standard 5.1.5.1.1 took effect, there was a decrease in production of whole blood-derived PLT concentrates (WBPCs). Point-of-issue ("rapid") immunoassays were used to screen a substantial proportion of WBPC PLTs, but were rarely used as secondary tests for previously cultured APs.

Conclusion: The survey identified variability in culture methods and release times with AP, while use of WBPC decreased after AABB Standard 5.1.5.1.1 became effective.
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http://dx.doi.org/10.1111/trf.12148DOI Listing
April 2013

Red blood cell transfusion: a clinical practice guideline from the AABB*.

Ann Intern Med 2012 Jul;157(1):49-58

MD, Division of General Internal Medicine, UMDNJ–Robert Wood Johnson Medical School, 125 Paterson Street, New Brunswick, NJ 08903, USA.

Description: Although approximately 85 million units of red blood cells (RBCs) are transfused annually worldwide, transfusion practices vary widely. The AABB (formerly, the American Association of Blood Banks) developed this guideline to provide clinical recommendations about hemoglobin concentration thresholds and other clinical variables that trigger RBC transfusions in hemodynamically stable adults and children.

Methods: These guidelines are based on a systematic review of randomized clinical trials evaluating transfusion thresholds. We performed a literature search from 1950 to February 2011 with no language restrictions. We examined the proportion of patients who received any RBC transfusion and the number of RBC units transfused to describe the effect of restrictive transfusion strategies on RBC use. To determine the clinical consequences of restrictive transfusion strategies, we examined overall mortality, nonfatal myocardial infarction, cardiac events, pulmonary edema, stroke, thromboembolism, renal failure, infection, hemorrhage, mental confusion, functional recovery, and length of hospital stay. RECOMMENDATION 1: The AABB recommends adhering to a restrictive transfusion strategy (7 to 8 g/dL) in hospitalized, stable patients (Grade: strong recommendation; high-quality evidence). RECOMMENDATION 2: The AABB suggests adhering to a restrictive strategy in hospitalized patients with preexisting cardiovascular disease and considering transfusion for patients with symptoms or a hemoglobin level of 8 g/dL or less (Grade: weak recommendation; moderate-quality evidence). RECOMMENDATION 3: The AABB cannot recommend for or against a liberal or restrictive transfusion threshold for hospitalized, hemodynamically stable patients with the acute coronary syndrome (Grade: uncertain recommendation; very low-quality evidence). RECOMMENDATION 4: The AABB suggests that transfusion decisions be influenced by symptoms as well as hemoglobin concentration (Grade: weak recommendation; low-quality evidence).
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http://dx.doi.org/10.7326/0003-4819-157-1-201206190-00429DOI Listing
July 2012

Emerging infectious agents and the nation's blood supply: responding to potential threats in the 21st century.

Transfusion 2013 Feb 13;53(2):438-54. Epub 2012 Jun 13.

Transfusion Medicine and Cellular Therapeutics Branch, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, Maryland 20892, USA.

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http://dx.doi.org/10.1111/j.1537-2995.2012.03742.xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3644861PMC
February 2013