Radiofrequency identification tracking system (RFID) significantly improves blood bank inventory management and decreases staff work effort.

BACKGROUND: Before implementation of the radio frequency identification (RFID) system, there was a high loss rate of 4.0%-4.3% of red blood cell (RBC) units every year expiring on the shelf in our transfusion service laboratory. We introduced RFID technology to improve inventory management and the burden of work on the staff. The goal of this study was to evaluate the impact of RFID technology on the inventory management of RBC units and the staff workload in a transfusion service laboratory. STUDY DESIGN AND METHODS: Using an RFID system involves encoding RBC units with an RFID tag capturing information such as donor identification number, product code, blood type, expiration date, product volume, and negative antigen(s). Tag information is collected through retrofitted storage shelves linked to the RFID server. The study analyzed RBC usage by unit and by volume (mL) and staff work effort to carry out inventory management tasks before and after the implementation of the RFID system. RESULTS: Implementation of the RFID technology reduced the loss, or discard, of RBC units to less than 1% annually (a statistically significant change, p < .001). The RFID computer dashboard provides a constant visual update of the inventory, allowing technologists to have accurate product counts and reducing their work burden. DISCUSSION: Implementation of RFID technology substantially reduced RBC product loss, improved inventory management, and lessened staff work burden.

Medication Deferrals in Blood Donors.

Medication use is extremely common in blood donors. Blood centers use various methods to obtain a history of medication use, all of which have strengths and weaknesses. Some data are available to develop policies for medications that impact product quality, transmissible disease testing, and infectious risks. Many blood centers defer donors for use of a small number of highly teratogenic medications, as a precautionary measure. Others also defer for possible harms related to the pharmacologic effects of medications. However, a single exposure to a blood component containing medication, with immediate dilution in the recipient's blood stream, is a very different situation from ongoing use of medication in a patient, with steady state concentrations achieved over time. It is therefore highly unlikely that these effects are relevant for recipient safety.

Modifications to therapeutic plasma exchange to achieve rapid exchange on cardiopulmonary bypass prior to pediatric cardiac transplant.

BACKGROUND: Cardiac transplants increasingly occur following placement of ventricular assist devices (VADs). A strong association exists between human leukocyte antigen (HLA) sensitization and VAD placement; however, desensitization protocols that utilize therapeutic plasma exchange (TPE) are fraught with technical challenges and are at increased risk of adverse events. In response to increased VAD utilization in our pre-transplant population, we developed a new institutional standard for TPE in the operating room. METHODS: Through a multidisciplinary effort, we developed an institutional protocol for intraoperative TPE immediately prior to cardiac transplantation after cannulation onto cardiopulmonary bypass (CPB). All procedures used the standard TPE protocol on the Terumo Optia (Terumo BCT, Lakewood, CO, USA), but incorporated multiple modifications to limit patients' bypass times, and to coordinate with the surgical teams. These modifications included deliberate misidentification of replacement fluid and maximization of the citrate infusion rate. RESULTS: These adjustments allowed the machine to run at maximal inlet speeds, minimizing duration of TPE. To date, 11 patients have been treated with this protocol. All survived their cardiac transplantation operation. Hypocalcemia and hypotension were noted; however, none of these adverse events appeared to have clinical impact. Technical complications included unexpected fibrin deposition in the TPE circuit and air in the inlet line due to surgical manipulation of the CPB cannula. No thromboembolic complications occurred in any patient. CONCLUSION: We feel that this procedure can be rapidly and safely performed in HLA sensitized pediatric patients on CPB to limit the risk of antibody mediated rejection of their heart transplant.

Multi-institutional experience with COVID-19 convalescent plasma in children.

BACKGROUND AND OBJECTIVES: Convalescent COVID-19 plasma (CCP) was developed and used worldwide as a treatment option by supplying passive immunity. Adult studies suggest administering high-titer CCP early in the disease course of patients who are expected to be antibody-negative; however, pediatric experience is limited. We created a multi-institutional registry to characterize pediatric patients (<18 years) who received CCP and to assess the safety of this intervention. METHODS: A REDCap survey was distributed. The registry collected de-identified data including demographic information (age, gender, and underlying conditions), COVID-19 disease features and concurrent treatments, CCP transfusion and safety events, and therapy response. RESULTS: Ninety-five children received CCP: 90 inpatients and 5 outpatients, with a median age of 10.2 years (range 0-17.9). They were predominantly Latino/Hispanic and White. The most frequent underlying medical conditions were chronic respiratory disease, immunosuppression, obesity, and genetic syndromes. CCP was primarily given as a treatment (95%) rather than prophylaxis (5%). Median total plasma dose administered and transfusion rates were 5.0 ml/kg and 2.6 ml/kg/h, respectively. The transfusions were well-tolerated, with 3 in 115 transfusions reporting mild reactions. No serious adverse events were reported. Severity scores decreased significantly 7 days after CCP transfusion or at discharge. Eighty-five patients (94.4%) survived to hospital discharge. All five outpatients survived to 60 days. CONCLUSIONS: CCP was found to be safe and well-tolerated in children. CCP was frequently given concurrently with other COVID-19-directed treatments with improvement in clinical severity scores ≥7 days after CCP, but efficacy could not be evaluated in this study.

Optimising the screening for haemoglobinopathies in pregnancy planning.

Haemoglobinopathies are among the most common inherited disorders around the world. In the United States the diagnosis of haemoglobinopathy or a carrier state is made by universal newborn screening. However, many individuals of childbearing age do not know they are a haemoglobinopathy carrier. Screening for common haemoglobinopathies is generally offered as a part of pregnancy planning so that prospective parents can be counselled regarding the risk of having a child with a haemoglobinopathy. Multiple tests exist to screen patients for presence of haemoglobinopathy carrier or disease state; however, it is crucial to order and interpret the results correctly to appropriately counsel couples. In this case series, we describe clinical scenarios where prospective parents were surprised to unexpectedly have a child with sickle cell disease, a haemoglobinopathy that causes severe clinical complications. Through these cases we demonstrate that deficiencies in testing can occur at different levels which may lead to incorrect estimation of the risk of having a child affected by a haemoglobinopathy. Consultation with a haematologist, laboratory medicine specialist, or genetic counsellor should be considered to select the appropriate test and interpret its results.

Using trends and outliers in managing delayed transfusions.

OBJECTIVES: To investigate if time to initiate a blood transfusion after an informative laboratory test could feasibly be used by the transfusion medicine service as a metric to monitor for transfusion delays. BACKGROUND: Delayed transfusions may result in patient morbidity and mortality, but no standards for timely transfusion have been developed. Information technology tools could be implemented to identify gaps in provision of blood and to recognise areas of improvement. MATERIALS AND METHODS: Data obtained from a children's hospital's data science platform and time from the release of laboratory results to the initiation of transfusions were calculated and weekly medians were used for trend analyses. Outlier events were obtained using locally estimated scatterplot smoothing and generalised extreme studentized deviate test. RESULTS: Overall, the number of outlier events on the timing of transfusions based on patients' haemoglobin level and platelet count were small (n = 1 and n = 0 for 139 weeks, respectively). Investigation of these events for adverse clinical outcomes was non-significant. CONCLUSIONS: Herein, we propose that the trends and outlier events could be further investigated and used to make decisions and implement protocols to improve patient care.

Measuring the Impact of a Blood Supply Shortage Using Data Science.

BACKGROUND: Transfusion medicine is the only section of the clinical laboratory that performs diagnostic testing and dispenses a drug (blood) on the basis of those results. However, not all of the testing that informs the clinical decision to prescribe a blood transfusion is performed in the blood bank. To form a holistic assessment of blood bank responsiveness to clinical needs, it is important to be able to merge blood bank data with datapoints from the hematology laboratory and the electronic medical record. METHODS: We built an interactive visualization of the time from hemoglobin result availability to initiation of red blood cell (RBC) transfusion and monitored the result over a 2-year period that coincided with several severe blood shortages. The visualization runs entirely on free software and was designed to be feasibly deployed on a variety of hospital information technology platforms without the need for significant data science expertise. RESULTS: Patient factors, such as hemoglobin concentration, blood type, and presence of minor blood group antibodies influenced the time to initiation of transfusion. Time to transfusion initiation did not appear to be significantly affected by periods of blood shortage. CONCLUSION: Overall, we demonstrate a proof of concept that complex, but clinically important, blood bank quality metrics can be generated with the support of a free, user-friendly system that aggregates data from multiple sources.

Blood donor eligibility criteria for medical conditions: A BEST collaborative study.

BACKGROUND AND OBJECTIVES: Donor eligibility questions and criteria for medical conditions vary between blood centres, suggesting that they are based more on local regulations or experience, rather than on published data, which are limited. As the donor population ages, medical conditions become more common. We assessed donor health assessment criteria at blood centre members of the Biomedical Excellence for Safer Transfusion (BEST) Collaborative. Our aim was to compare eligibility criteria and determine their underlying basis. MATERIALS AND METHODS: A REDCap survey was sent to blood centre participants, based on medical conditions of greatest interest suggested by the Donor Studies Team of the BEST Collaborative. Participants were asked about current donor health assessment questions, deferral criteria and the basis for their deferral policy (donor risk, recipient risk or both) for 20 medical conditions. RESULTS: Complete responses were received from 26 blood donor centres (24 separate responses) representing a combination of hospital-based centres, large regional centres and community/national blood centres in 14 different countries. Most centres specifically ask about heart and lung conditions, whereas fewer than half inquire about kidney, gastrointestinal or neurological conditions. North American blood centres tended to be less restrictive, while regulatory restrictions are more prevalent in Europe. Most participants felt that the criteria were based on regulatory requirements or experience, rather than on published data. CONCLUSION: There is considerable variability in criteria by region. Ideally, criteria would be more evidence-based rather than based on regulatory requirements or experience. Deferral criteria must balance donor and recipient safety and maintain an adequate blood supply.

Current state and positive impact of hospital-based blood donor centers in the United States.

BACKGROUND: The COVID-19 pandemic has brought tremendous challenges to the United States blood supply. Decreased collections have caused blood product shortages. The number of hospital-based donor centers (HBDCs) has decreased in the past decades, but they provide important support to their hospital systems. MATERIALS/METHODS: We identified 79 active HBDCs through an information request to the FDA. These centers were invited to participate in a survey about their activities, blood product collections, and perceived value. RESULTS: Thirty-six centers responded (46% response rate). The centers represented a wide range of states and geographic settings. Whole blood collection was most common, but some respondents also prepared specialized products such as COVID-19 convalescent plasma and pathogen-reduced platelets. Positive impacts of HBDCs included inventory availability, cost-effectiveness/savings, community outreach, supporting special patient populations, and collecting specialty products. All respondents anticipate at least stable operations, if not growth, in the future. CONCLUSION: HBDCs continue to be valuable assets in addressing emerging patient transfusion needs. Their unique offerings are tailored to the populations their hospitals support, and demonstrate the value in having the collection infrastructure in place to rapidly respond to critical shortages. This survey provides benchmark data about a broad group of HBDCs including products prepared, inventory self-sufficiency levels, and reasons for positive impact.

Patterns of paediatric massive blood transfusion protocol use in trauma and non-trauma patients.

BACKGROUND: Massive blood transfusion is infrequently required by children but can be a lifesaving intervention for haemorrhage or coagulopathy. Product volumes and ratios administered during the initiation of paediatric massive blood transfusion protocol (MBTP) are highly variable and the optimal component ratio is unknown. METHODS/MATERIALS: We performed a single-centre retrospective chart review of patients (<20 years) who received MBTP activation from August 2012 through January 2018. Logistic regression was used to determine the association between MBTP use characteristics (including blood product type and volume transfused, extracorporeal membrane oxygenation [ECMO] support, and cardiac arrest occurrence) and 24-h mortality. "Low" product ratio was defined as a ratio of plasma or platelets to red blood cells (RBCs) of <1:2 and "high" as ≥1:2. RESULTS: Ninety-eight MBTPs were activated for 89 patients (range 1-4 per patient). The most common underlying diagnoses were congenital heart disease (CHD, n = 28, 31.5%), followed by cardiopulmonary disease, and trauma. CHD patients required the greatest volume of RBCs (226.3 ml/kg, 95%CI [160.0, 292.7], p = 0.002) and platelets (46.7 ml/kg, 95%CI [33.2, 60.2], p < 0.001). A "low" product ratio was more common for the MBTP, with its incidence similar among the underlying diagnoses. CONCLUSION: An MBTP developed for trauma patients can be applied to non-trauma patients but standard MBTP components may not be optimal for all children. These findings show that underlying patient diagnoses may be a factor when designing an MBTP for a heterogeneous paediatric population.

Screening for new red blood cell alloantibodies after transfusion in patients with sickle cell disease.

BACKGROUND: Patients with sickle cell disease (SCD) are frequent recipients of red blood cell (RBC) transfusions and are at risk for RBC alloimmunization. RBC alloimmunization is diagnosed by identifying RBC alloantibodies as part of pre-transfusion testing, but this testing fails to detect alloantibodies that have evanesced. It may be beneficial to screen for new RBC alloantibody development after transfusion before possible antibody evanescence. STUDY DESIGN AND METHODS: Our institution started a new initiative for episodically transfused patients with SCD to obtain at least one antibody screen 2-6 months after transfusion as part of their clinical care. A database was created to prospectively track all transfused patients for 1 year and their post-transfusion antibody screen results. Patients received prophylactically CEK-matched RBC units. RESULTS: During the study year, 138 patients with SCD received a total of 242 RBC transfusions. Patients with a history of an RBC alloantibody (n = 13, 9.4%) had previously received more RBC units than non alloimmunized patients (median 11 vs. 2 RBC units, p = .0002). A total of 337 post-transfusion antibody screens were obtained in 127 patients (92.0%) with 110 patients (79.7%) having at least one antibody screen 2-6 months post-transfusion. With this prospective testing, two new RBC alloantibodies (anti-C and -M) were identified in two patients. CONCLUSION: It is feasible to test for new RBC alloantibody development in most episodically transfused patients with SCD as part of their routine care. The yield of this screening appears low with CEK matching, but it could still provide important information for individual patients.

Erythrocyte T-antigen activation in children: Patient characteristics and the hemolytic risk of transfusion.

BACKGROUND: T-antigen activation usually occurs upon red blood cell (RBC) membrane cryptantigen exposure due to bacterial enzymes. Although uncommon, the condition is probably underrecognized. There is concern about hemolysis after plasma and plasma-containing platelet transfusions due to naturally occurring anti-T antibody in healthy blood donors. However, experts have debated the extent and severity of clinical hemolysis due to anti-T. PROCEDURE: We retrospectively identified patients who tested positive for polyagglutination with Arachis hypogea and Glycine max lectins from 2008 to 2019. The records of the patients were reviewed to determine clinical symptoms, laboratory evidence of hemolysis, need for transfusion, and clinical outcomes. RESULTS: Ten patients were identified. At diagnosis, all were anemic and four had thrombocytopenia. Severe Streptococcus pneumoniae infection affected seven patients; one died. Seven of 10 patients (70%) had laboratory evidence of hemolysis. Peripheral blood smear findings in six patients included RBC agglutination and changes suggesting hemolysis (spherocytes and schistocytes), but three had unremarkable RBC morphology. Four patients required plasma or platelet transfusions; all survived to discharge. CONCLUSIONS: T-antigen activation is a rare entity. Most patients diagnosed at our hospital had hemolytic anemia and severe pneumococcal infection. Hemoglobin decreased after plasma and platelet transfusions in all patients assessed, but these transfusions were necessary to support treatment. RBCs were given to maintain appropriate hemoglobin levels.

Kinetics of Viral Clearance and Antibody Production Across Age Groups in Children with Severe Acute Respiratory Syndrome Coronavirus 2 Infection.

OBJECTIVES: To improve understanding of transition from viral infection to viral clearance, and antibody response in pediatric patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. STUDY DESIGN: This retrospective analysis of children tested for SARS-CoV-2 by reverse transcription (RT) polymerase chain reaction (PCR) and immunoglobulin G antibody at a quaternary-care, free-standing pediatric hospital between March 13, 2020, and June 21, 2020, included 6369 patients who underwent PCR testing and 215 patients who underwent antibody testing. During the initial study period, testing focused primarily on symptomatic children; the later study period included asymptomatic patients who underwent testing as preadmission or preprocedural screening. We report the proportion of positive and negative tests, time to viral clearance, and time to seropositivity. RESULTS: The rate of positivity varied over time due to viral circulation in the community and transition from targeted testing of symptomatic patients to more universal screening of hospitalized patients. Median duration of viral shedding (RT-PCR positivity) was 19.5 days and time from RT-PCR positivity to negativity was 25 days. Of note, patients aged 6 through 15 years demonstrated a longer time of RT-PCR positivity to negativity, compared with patients aged 16 through 22 years (median 32 vs 18 days, P = .015). Median time to seropositivity, by chemiluminescent testing, from RT-PCR positivity was 18 days, whereas median time to reach adequate levels of neutralizing antibodies (defined as comparable with 160 titer by plaque reduction neutralization testing) was 36 days. CONCLUSIONS: The majority of patients demonstrated a prolonged period of viral shedding after infection with SARS CoV-2. It is unknown whether this correlates with persistent infectivity. Only 17 of 33 patients demonstrated adequate neutralizing antibodies during the time frame of specimen collection. It remains unknown whether immunoglobulin G antibody against spike structured proteins correlates with immunity, and how long antibodies and potential protection persist.

Therapeutic plasma exchange for neuromyelitis optica spectrum disorder: A multicenter retrospective study by the ASFA neurologic diseases subcommittee.

IMPORTANCE: Neuromyelitis optica/neuromyelitis optica spectrum disorder patients' response to therapeutic plasma exchange (TPE) is currently incompletely characterized. OBJECTIVE: Our study aims to understand the clinical status improvement of neuromyelitis optica/neuromyelitis optica spectrum disorder patients treated with TPE. DESIGN, SETTING, AND PARTICIPANTS: This is a multicenter retrospective study conducted between 1 January 2003 and 31 July 2017 at 13 US hospitals performing apheresis procedures. Subjects studied were diagnosed with neuromyelitis optica/neuromyelitis optica spectrum disorder who received TPE during presentation with acute disease. MAIN OUTCOMES AND MEASURES: The primary outcome was clinical status improvement in patients treated with TPE. Secondary measures were procedural and patient characteristics associated with response to treatment. RESULTS: We evaluated 114 patients from 13 institutions. There was a female predilection. The largest ethnic group affected was non-Hispanic Caucasian. The average age of diagnosis was 43.1 years. The average time to diagnosis was 3.1 years. On average, five procedures were performed during each treatment series. The most commonly performed plasma volume exchange was 1.0 to 1.25 using 5% albumin as replacement fluid. Most patients (52%) did not require an additional course of TPE and noted "mild" to "moderate" clinical status improvement. Maximal symptom improvement appeared by the fourth or fifth TPE treatment. CONCLUSION AND RELEVANCE: TPE improved the clinical status of patients. Adults responded more favorably than children. Procedural characteristics, including number of TPEs, plasma volume exchanged, and replacement fluid used, were similar between institutions. TPE was well-tolerated and had a low severe adverse event profile.

New Approaches and Trials in Pediatric Transfusion Medicine.

Blood transfusions are frequently lifesaving, but there is growing awareness of their associated infectious and noninfectious adverse events. Patient blood management advocates for judicious use of transfusions and considerations of alternatives to correct anemia or achieve hemostasis. Several transfusion practices, either already implemented or under investigation, aim to further improve the safety of transfusions. An enduring challenge in pediatric and neonatal transfusion practice is that studies typically focus on adults, and findings are extrapolated to younger patients. This article aims to summarize some of the newer developments in transfusion medicine with a focus on the neonatal and pediatric population.

Identification of red blood cell antibodies in maternal breast milk implicated in prolonged hemolytic disease of the fetus and newborn.

BACKGROUND: Alloantibodies against more than 50 non-ABO blood group antigens have been implicated in hemolytic disease of the fetus and newborn (HDFN) and are expected to wane within weeks after delivery. Persistent anemia leads to the hypothesis of continued exposure to red blood cell (RBC) alloantibodies via breast milk, which has been shown in a murine model and suggested in rare case reports. CASE REPORT: We report three cases of prolonged HDFN in two neonates with anti-D HDFN and one with anti-Jka HDFN. Patient 1 demonstrated 4+ anti-D serologic testing beyond 2 months; therefore, antibody testing was performed on maternal breast milk. METHODS: Maternal serum samples were tested for the presence of unexpected antibodies using standard Ortho gel card and 37 °C 60 minutes with anti-human globulin (AHG) tube saline methods. Antibody titrations were performed using the standard 37 °C 60 minutes to AHG tube saline method. Fresh breast milk samples were tested using the standard 37 °C 60 minutes to AHG tube saline method for both unexpected antibodies and titration study. Fresh breast milk from an O-positive, antibody-negative donor was used as control for any reactivity that may have been due to milk solids or proteins alone. RESULTS: Using a known methodology applied in a novel way to test breast milk for RBC alloantibodies, antibodies against fetal RBCs were identified in the maternal breast milk of three patients. CONCLUSION: Maternal RBC alloantibodies are present in breast milk and may be clinically significant in patients with prolonged recovery from HDFN.