Last data update: Oct 28, 2024. (Total: 48004 publications since 2009)
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Query Trace: Sapiano MRP[original query] |
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Supplemental findings of the 2021 National Blood Collection and Utilization Survey
Kracalik I , Sapiano MRP , Wild RC , Chavez Ortiz J , Stewart P , Berger JJ , Basavaraju SV , Free RJ . Transfusion 2023 63 Suppl 4 S19-S42 BACKGROUND: The Department of Health and Human Services' National Blood Collection and Utilization Survey (NBCUS) has been conducted biennially since 1997. Data are used to estimate national blood collection and use. Supplemental data from the 2021 NBCUS not presented elsewhere are presented here. METHODS: Data on survey participation, donor characteristics, blood component cost, transfusion-associated adverse reactions, and implementation of blood safety measures, including pathogen-reduction of platelets, during 2021, were analyzed. Comparisons are made to 2019 survey data where available (2013-2019 for survey participation). RESULTS: During 2021, there were 11,507,000 successful blood donations in the United States, a 4.8% increase from 2019. Persons aged 45-64 years accounted for 42% of all successful blood donations. Donations by persons aged 65 years and older increased by 40.7%, while donations among minorities and donors aged <25 years decreased. From 2019 to 2021, the median price hospitals paid per unit of leukoreduced red blood cells, leukoreduced and pathogen-reduced apheresis platelets, and fresh frozen plasma increased. The largest increase in price per unit of blood component in 2021 was for leukoreduced apheresis platelets, which increased by ~$51. Between 2019 and 2021, the proportion of transfusing facilities reporting use of pathogen-reduced platelets increased, from 13% to 60%. Transfusion-related adverse reactions declined slightly between 2019 and 2021, although the rate of transfusion-transmitted bacterial infections remained unchanged. CONCLUSION: During 2021, blood donations increased nationally, although donations from those aged <25 years and minorities declined. The prices hospitals paid for most blood products increased, as did the use of pathogen-reduced platelets. |
Epidemiology of sepsis in US children and young adults
Magill SS , Sapiano MRP , Gokhale R , Nadle J , Johnston H , Brousseau G , Maloney M , Ray SM , Wilson LE , Perlmutter R , Lynfield R , DeSilva M , Sievers M , Irizarry L , Dumyati G , Pierce R , Zhang A , Kainer M , Fiore AE , Dantes R , Epstein L . Open Forum Infect Dis 2023 10 (5) ofad218 BACKGROUND: Most multicenter studies of US pediatric sepsis epidemiology use administrative data or focus on pediatric intensive care units. We conducted a detailed medical record review to describe sepsis epidemiology in children and young adults. METHODS: In a convenience sample of hospitals in 10 states, patients aged 30 days-21 years, discharged during 1 October 2014-30 September 2015, with explicit diagnosis codes for severe sepsis or septic shock, were included. Medical records were reviewed for patients with documentation of sepsis, septic shock, or similar terms. We analyzed overall and age group-specific patient characteristics. RESULTS: Of 736 patients in 26 hospitals, 442 (60.1%) had underlying conditions. Most patients (613 [83.3%]) had community-onset sepsis, although most community-onset sepsis was healthcare associated (344 [56.1%]). Two hundred forty-one patients (32.7%) had outpatient visits 1-7 days before sepsis hospitalization, of whom 125 (51.9%) received antimicrobials ≤30 days before sepsis hospitalization. Age group-related differences included common underlying conditions (<5 years: prematurity vs 5-12 years: chronic pulmonary disease vs 13-21 years: chronic immunocompromise); medical device presence ≤30 days before sepsis hospitalization (1-4 years: 46.9% vs 30 days-11 months: 23.3%); percentage with hospital-onset sepsis (<5 years: 19.6% vs ≥5 years: 12.0%); and percentage with sepsis-associated pathogens (30 days-11 months: 65.6% vs 13-21 years: 49.3%). CONCLUSIONS: Our data suggest potential opportunities to raise sepsis awareness among outpatient providers to facilitate prevention, early recognition, and intervention in some patients. Consideration of age-specific differences may be important as approaches are developed to improve sepsis prevention, risk prediction, recognition, and management. |
Impact of the COVID-19 pandemic on blood donation and transfusions in the United States in 2020
Basavaraju SV , Free RJ , Chavez Ortiz JL , Stewart P , Berger J , Sapiano MRP . Transfusion 2023 63 Suppl 4 S1-S7 INTRODUCTION: Reports have suggested the COVID-19 pandemic resulted in blood donation shortages and adverse impacts on the blood supply. Using data from the National Blood Collection and Utilization Survey (NBCUS), we quantified the pandemic's impact on red blood cell (RBC) and apheresis platelet collections and transfusions in the United States during year 2020. METHODS: The 2021 NBCUS survey instrument was modified to include certain blood collection and utilization variables for 2020. The survey was distributed to all US blood collection centers, all US hospitals performing ≥1000 surgeries annually, and a 40% random sample of hospitals performing 100-999 surgeries annually. Weighting and imputation were used to generate national estimates for whole blood and apheresis platelet donation; RBC and platelet transfusion; and convalescent plasma distribution. RESULTS: Whole blood collections were stable from 2019 (9,790,000 units; 95% CI: 9,320,000-10,261,000) to 2020 (9,738,000 units; 95% CI: 9,365,000-10,110,000). RBC transfusions decreased by 6.0%, from 10,852,000 units (95% CI: 10,444,000-11,259,000) in 2019 to 10,202,000 units (95% CI: 9,811,000-10,593,000) in 2020. Declines were steepest during March-April 2020, with transfusions subsequently rebounding. Apheresis platelet collections increased from 2,359,000 units (95% CI: 2,240,000-2,477,000) in 2019 to 2,408,000 units (95% CI: 2,288,000-2,528,000) in 2020. Apheresis platelet transfusions increased from 1,996,000 units (95% CI: 1,846,000-2,147,000) in 2019 to 2,057,000 units (95% CI: 1,902,000-2,211,000) in 2020. CONCLUSION: The COVID-19 pandemic resulted in reduced blood donations and transfusions in some months during 2020 but only a minimal annualized decline compared with 2019. |
Continued stabilization of blood collections and transfusions in the United States: Findings from the 2021 National Blood Collection and Utilization Survey
Free RJ , Sapiano MRP , Chavez Ortiz JL , Stewart P , Berger J , Basavaraju SV . Transfusion 2023 63 Suppl 4 S8-S18 BACKGROUND: National Blood Collection and Utilization Surveys (NBCUS) have reported decreases in U.S. blood collections and transfusions since 2008. The declines began to stabilize in 2015-2017, with a subsequent increase in transfusions in 2019. Data from the 2021 NBCUS were analyzed to understand the current dynamics of blood collection and use in the United States. METHODS: In March 2022, all community-based (53) and hospital-based (83) blood collection centers, a randomly selected 40% of transfusing hospitals performing 100-999 annual inpatient surgeries, and all transfusing hospitals performing ≥1000 annual inpatient surgeries were sent a 2021 NBCUS survey to ascertain blood collection and transfusion data. Responses were compiled, and national estimates were calculated for the number of units of blood and blood components collected, distributed, transfused, and outdated in 2021. Weighting and imputation were applied to account for non-responses and missing data, respectively. RESULTS: Survey response rates were 92.5% (49/53) for community-based blood centers, 74.7% (62/83) for hospital-based blood centers, and 76.3% (2102/2754) for transfusing hospitals. Overall, 11,784,000 (95% confidence interval [CI], 11,392,000-12,177,000) whole blood and apheresis red blood cell (RBC) units were collected in 2021, a 1.7% increase from 2019; 10,764,000 (95% CI, 10,357,000-11,171,000) whole blood-derived and apheresis RBC units were transfused, a 0.8% decrease. Total platelet units distributed increased by 0.8%; platelet units transfused decreased by 3.0%; plasma units distributed increased by 16.2%; and plasma units transfused increased by 1.4%. DISCUSSION: The 2021 NBCUS findings demonstrate a stabilization in U.S. blood collections and transfusions, suggesting a plateau has been reached for both. |
The Association Between State-Issued Mask Mandates and County COVID-19 Hospitalization Rates.
Dunphy C , Joo H , Sapiano MRP , Howard-Williams M , McCord R , Sunshine G , Kao SY , Guy GPJr , Weber R , Gakh M , Ekwueme DU . J Public Health Manag Pract 2022 28 (6) 712-719 CONTEXT: Mask mandates are one form of nonpharmaceutical intervention that has been utilized to combat the spread of SARS-CoV2, the virus that causes COVID-19. OBJECTIVE: This study examines the association between state-issued mask mandates and changes in county-level and hospital referral region (HRR)-level COVID-19 hospitalizations across the United States. DESIGN: Difference-in-difference and event study models were estimated to examine the association between state-issued mask mandates and COVID-19 hospitalization outcomes. PARTICIPANTS: All analyses were conducted with US county-level data. INTERVENTIONS: State-issued mask mandates. County-level data on the mandates were collected from executive orders identified on state government Web sites from April 1, 2020, to December 31, 2020. MAIN OUTCOME MEASURES: Daily county-level (and HRR-level) estimates of inpatient beds occupied by patients with confirmed or suspected COVID-19 were collected by the US Department of Health and Human Services. RESULTS: The state issuing of mask mandates was associated with an average of 3.6 fewer daily COVID-19 hospitalizations per 100 000 people (P < .05) and a 1.2-percentage-point decrease in the percentage of county beds occupied with COVID-19 patients (P < .05) within 70 days of taking effect. Event study results suggest that this association increased the longer mask mandates were in effect. In addition, the results were robust to analyses conducted at the HRR level. CONCLUSIONS: This study demonstrated that state-issued mask mandates were associated with reduction in COVID-19 hospitalizations across the United States during the earlier portion of the pandemic. As new variants of the virus cause spikes in COVID-19 cases, reimposing mask mandates in indoor and congested public areas, as part of a layered approach to community mitigation, may reduce the spread of COVID-19 and lessen the burden on our health care system. |
Supplemental findings of the 2019 National Blood Collection and Utilization Survey
Mowla SJ , Sapiano MRP , Jones JM , Berger JJ , Basavaraju SV . Transfusion 2021 61 Suppl 2 S11-S35 INTRODUCTION: Supplemental data from the 2019 National Blood Collection and Utilization Survey (NBCUS) are presented and include findings on donor characteristics, autologous and directed donations and transfusions, platelets (PLTs), plasma and granulocyte transfusions, pediatric transfusions, transfusion-associated adverse events, cost of blood units, hospital policies and practices, and implementation of blood safety measures, including pathogen reduction technology (PRT). METHODS: National estimates were produced using weighting and imputation methods for a number of donors, donations, donor deferrals, autologous and directed donations and transfusions, PLT and plasma collections and transfusions, a number of crossmatch procedures, a number of units irradiated and leukoreduced, pediatric transfusions, and transfusion-associated adverse events. RESULTS: Between 2017 and 2019, there was a slight decrease in successful donations by 1.1%. Donations by persons aged 16-18 decreased by 10.1% while donations among donors >65 years increased by 10.5%. From 2017 to 2019, the median price paid for blood components by hospitals for leukoreduced red blood cell units, leukoreduced apheresis PLT units, and for fresh frozen plasma units continued to decrease. The rate of life-threatening transfusion-related adverse reactions continued to decrease. Most whole blood/red blood cell units (97%) and PLT units (97%) were leukoreduced. CONCLUSION: Blood donations decreased between 2017 and 2019. Donations from younger donors continued to decline while donations among older donors have steadily increased. Prices paid for blood products by hospitals decreased. Implementation of PRT among blood centers and hospitals is slowly expanding. |
Hospital capacities and shortages of healthcare resources among US hospitals during the coronavirus disease 2019 (COVID-19) pandemic, National Healthcare Safety Network (NHSN), March 27-July 14, 2020.
Wu H , Soe MM , Konnor R , Dantes R , Haass K , Dudeck MA , Gross C , Leaptrot D , Sapiano MRP , Allen-Bridson K , Wattenmaker L , Peterson K , Lemoine K , Chernetsky Tejedor S , Edwards JR , Pollock D , Benin AL . Infect Control Hosp Epidemiol 2021 43 (10) 1-12 During March 27-July 14, 2020, the CDC's National Healthcare Safety Network extended its surveillance to hospital capacities responding to COVID-19 pandemic. The data showed wide variations across hospitals in case burden, bed occupancies, ventilator usage, and healthcare personnel and supply status. These data were used to inform emergency responses. |
Has the trend of declining blood transfusions in the United States ended Findings of the 2019 National Blood Collection and Utilization Survey
Jones JM , Sapiano MRP , Mowla S , Bota D , Berger JJ , Basavaraju SV . Transfusion 2021 61 Suppl 2 S1-S10 INTRODUCTION: Previous iterations of National Blood Collection and Utilization Survey (NBCUS) have demonstrated declines in blood collection and transfusion in the United States since 2008, including declines of 3.0% and 6.1% in red blood cell (RBC) collections and transfusions between 2015 and 2017, respectively. This study describes results of the 2019 NBCUS. METHODS: The survey was distributed to all US blood collection centers, all hospitals performing ≥1000 surgeries annually, and a 40% random sample of hospitals performing 100-999 surgeries annually. Weighting and imputation were used to generate national estimates for units of blood and components collected, distributed, transfused, and outdated. RESULTS: In 2019, 11,590,000 RBC units were collected (95% confidence interval [CI], 11,151,000-12,029,000 units), a 5.1% decrease compared with 2017, while 10,852,000 RBC units were transfused (95% CI, 10,444-11,259 units), a 2.5% increase from 2017. Between 2017 and 2019, platelet distributions (2,508,000 units; 95% CI, 2,375,000-2,641,000 units) decreased by 2.0%, and plasma distributions (2,679,000 units; 95% CI, 2,525,000-2,833,000 units) decreased by 16.5%. During the same time period, platelet transfusions (2,243,000 units; 95% CI, 1,846,000-2,147,000 units) increased by 15.8% and plasma transfusions (2,185,000 units; 95% CI, 2,068,000-2,301,000 units) decreased by 8.0%. CONCLUSION: Utilization of RBC in the United States might have reached a nadir. Between 2017 and 2019, RBC collections declined while RBC transfusions did not significantly change, suggesting a narrowing between blood supply and demand. Monitoring national blood collection and utilization data is integral to understanding trends in blood supply safety and availability. |
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.
Kracalik I , Mowla S , Katz L , Cumming M , Sapiano MRP , Basavaraju SV . Transfusion 2021 61 Suppl 2 S36-S43 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. |
A Comparison of Transfusion-Related Adverse Reactions Among Apheresis Platelets, Whole Blood-Derived Platelets, and Platelets Subjected to Pathogen Reduction Technology as Reported to the National Healthcare Safety Network Hemovigilance Module
Mowla SJ , Kracalik IT , Sapiano MRP , O'Hearn L , Andrzejewski CJr , Basavaraju SV . Transfus Med Rev 2021 35 (2) 78-84 Despite advances in transfusion safety, concerns with safety of platelet transfusions remain including platelet-related sepsis and higher reaction rates observed among patients receiving apheresis platelets (APLTs). National Healthcare Safety Network (NHSN) Hemovigilance Module (HM) data were analyzed to quantify the burden and severity of adverse reactions occurring from APLTs and whole blood-derived platelets (WBD-PLTs). Facilities participating in NHSN HM during 2010-2018 were included. Adverse reaction rates (number per 100,000 components transfused) were calculated for APLTs and WBD-PLTs stratified by severity, use of platelet additive solution (PAS), and pathogen reduction technology (PRT). Chi-square tests were used to compare rates. During the study interval, 2,000,589 platelets were transfused: 1,435,154 APLTs; 525,902 WBD-PLTs; and among APLTs, 39,533 PRT-APLTs. APLT adverse reaction rates were higher (478 vs 70/ 100,000, P< .01) and more often serious (34 vs 6/100,000; P< .01) compared with WBD-PLTs. Adverse reactions were higher among PRT-APLTs (572/100,000) and were less often serious (18/100,000) compared with non-PRT-APLTs (35/100,000) although this association was not statistically significant. Among components implicated in adverse reactions, 92% of APLTs were suspended in plasma. Compared with PRT-APLTs stored in PAS, rates were higher among units stored in plasma (760 vs 525/100,000). Most serious reactions (75%) were allergic. No transfusion-transmitted infections were reported among PRT-APLTs. APLTs were associated with a 6-fold and 2-fold higher serious adverse reaction risks compared with WBD-PLTs and PRT-APLTs, respectively. These findings demonstrate the importance of monitoring transfusion-related adverse reactions to track the safety of platelet transfusions and quantify the impact of mitigation strategies through national hemovigilance systems. |
Transfusion-related adverse reactions: Data from the National Healthcare Safety Network Hemovigilance Module - United States, 2013-2018
Kracalik I , Mowla S , Basavaraju SV , Sapiano MRP . Transfusion 2021 61 (5) 1424-1434 BACKGROUND: Despite current blood safety measures, transfusion recipients can experience transfusion-related adverse reactions. Monitoring these reactions can aid in understanding the effectiveness of current transfusion safety measures. Data from the National Healthcare Safety Network Hemovigilance Module were used to quantify adverse reaction risk. METHODS: Facilities reporting at least one month of transfused blood components and transfusion-related adverse reactions during January 2013-December 2018 were included. Adverse reaction rates (number per 100,000 components transfused) were calculated for transfused components stratified by component type, collection, and modification methods. RESULTS: During 2013-2018, 201 facilities reported 18,308 transfusion-related adverse reactions among 8.34 million blood components transfused (220/100,000). Adverse reactions were higher among apheresis (486/100,000) and pathogen-reduced platelets (579/100,000) than apheresis red blood cells (197/100,000). Allergic reactions (41%) were most common. There were 23 fatalities and 9% of all adverse reactions were serious (severe, life-threatening, or fatal). Reactions involving pulmonary complications (transfusion-associated circulatory overload, transfusion-related acute lung injury and transfusion-associated dyspnea) accounted for 35% of serious reactions but 65% of fatalities. Most (76%) of the 37 transfusion-transmitted infections were serious; none involved pathogen-reduced components. CONCLUSIONS: One in 455 blood components transfused was associated with an adverse reaction although the risk of serious reactions (1 in 6224) or transfusion-transmitted infections (1 in 225,440) was lower. Some serious reactions identified were preventable, suggesting additional safety measures may be beneficial. Higher reaction rates identified among pathogen-reduced platelets require further study. These findings highlight the importance of monitoring reactions through national hemovigilance to inform current safety measures and the need for strategies to increase healthcare facility participation. |
Rates and causative pathogens of surgical site infections attributed to liver transplant procedures and other hepatic, biliary or pancreatic procedures, 2015-2018
Chea N , Sapiano MRP , Zhou L , Epstein L , Guh A , Edwards JR , Allen-Bridson K , Russo V , Watkins J , Pouch SM , Magill SS . Transpl Infect Dis 2021 23 (4) e13589 Liver transplant recipients are at high risk for surgical site infections (SSIs). Limited data are available on SSI epidemiology following liver transplant procedures (LTPs). We analyzed data on SSIs from 2015-2018 reported to CDC's National Healthcare Safety Network to determine rates, pathogen distribution, and antimicrobial resistance after LTPs and other hepatic, biliary, or pancreatic procedures (BILIs). LTP and BILI SSI rates were 5.7% and 5.9%, respectively. The odds of SSI after LTP were lower than after BILI (adjusted odds ratio = 0.70, 95% confidence interval 0.57-0.85). Among LTP SSIs, 43.1% were caused by Enterococcus spp., 17.2% by Candida spp., and 15.0% by coagulase-negative Staphylococcus spp. (CNS). Percentages of SSIs caused by Enterococcus faecium or CNS were higher after LTPs than BILIs, whereas percentages of SSIs caused by Enterobacteriaceae, Enterococcus faecalis, or viridans streptococci were higher after BILIs. Antimicrobial resistance was common in LTP SSI pathogens, including E. faecium (69.4% vancomycin-resistant); E. coli (68.8% fluoroquinolone-non-susceptible, 44.7% extended spectrum cephalosporin [ESC]-non-susceptible); and K. pneumoniae and K. oxytoca (39.4% fluoroquinolone-non-susceptible, 54.5% ESC-non-susceptible). National LTP SSI pathogen and resistance data can help prioritize studies to determine effective interventions to prevent SSIs and reduce antimicrobial resistance in liver transplant recipients. |
Impact of coronavirus disease 2019 (COVID-19) on US Hospitals and Patients, April-July 2020.
Sapiano MRP , Dudeck MA , Soe M , Edwards JR , O'Leary EN , Wu H , Allen-Bridson K , Amor A , Arcement R , Chernetsky Tejedor S , Dantes R , Gross C , Haass K , Konnor R , Kroop SR , Leaptrot D , Lemoine K , Nkwata A , Peterson K , Wattenmaker L , Weiner-Lastinger LM , Pollock D , Benin AL . Infect Control Hosp Epidemiol 2021 43 (1) 1-28 OBJECTIVE: The rapid spread of SARS-CoV-2 throughout key regions of the United States (U.S.) in early 2020 placed a premium on timely, national surveillance of hospital patient censuses. To meet that need, the Centers for Disease Control and Prevention's National Healthcare Safety Network (NHSN), the nation's largest hospital surveillance system, launched a module for collecting hospital COVID-19 data. This paper presents time series estimates of the critical hospital capacity indicators during April 1-July 14, 2020. DESIGN: From March 27-July 14, 2020, NHSN collected daily data on hospital bed occupancy, number of hospitalized patients with COVID-19, and availability/use of mechanical ventilators. Time series were constructed using multiple imputation and survey weighting to allow near real-time daily national and state estimates to be computed. RESULTS: During the pandemic's April peak in the United States, among an estimated 431,000 total inpatients, 84,000 (19%) had COVID-19. Although the number of inpatients with COVID-19 decreased during April to July, the proportion of occupied inpatient beds increased steadily. COVID-19 hospitalizations increased from mid-June in the South and Southwest after stay-at-home restrictions were eased. The proportion of inpatients with COVID-19 on ventilators decreased from April to July. CONCLUSIONS: The NHSN hospital capacity estimates served as important, near-real time indicators of the pandemic's magnitude, spread, and impact, providing quantitative guidance for the public health response. Use of the estimates detected the rise of hospitalizations in specific geographic regions in June after declining from a peak in April. Patient outcomes appeared to improve from early April to mid-July. |
Serologic testing of U.S. blood donations to identify SARS-CoV-2-reactive antibodies: December 2019-January 2020.
Basavaraju SV , Patton ME , Grimm K , Rasheed MAU , Lester S , Mills L , Stumpf M , Freeman B , Tamin A , Harcourt J , Schiffer J , Semenova V , Li H , Alston B , Ategbole M , Bolcen S , Boulay D , Browning P , Cronin L , David E , Desai R , Epperson M , Gorantla Y , Jia T , Maniatis P , Moss K , Ortiz K , Park SH , Patel P , Qin Y , Steward-Clark E , Tatum H , Vogan A , Zellner B , Drobeniuc J , Sapiano MRP , Havers F , Reed C , Gerber S , Thornburg NJ , Stramer SL . Clin Infect Dis 2020 72 (12) e1004-e1009 BACKGROUND: SARS-CoV-2, the virus that causes COVID-19 disease, was first identified in Wuhan, China in December 2019, with subsequent worldwide spread. The first U.S. cases were identified in January 2020. METHODS: To determine if SARS-CoV-2 reactive antibodies were present in sera prior to the first identified case in the U.S. on January 19, 2020, residual archived samples from 7,389 routine blood donations collected by the American Red Cross from December 13, 2019 to January 17, 2020, from donors resident in nine states (California, Connecticut, Iowa, Massachusetts, Michigan, Oregon, Rhode Island, Washington, and Wisconsin) were tested at CDC for anti-SARS-CoV-2 antibodies. Specimens reactive by pan-immunoglobulin (pan Ig) enzyme linked immunosorbent assay (ELISA) against the full spike protein were tested by IgG and IgM ELISAs, microneutralization test, Ortho total Ig S1 ELISA, and receptor binding domain / Ace2 blocking activity assay. RESULTS: Of the 7,389 samples, 106 were reactive by pan Ig. Of these 106 specimens, 90 were available for further testing. Eighty four of 90 had neutralizing activity, 1 had S1 binding activity, and 1 had receptor binding domain / Ace2 blocking activity >50%, suggesting the presence of anti-SARS-CoV-2-reactive antibodies. Donations with reactivity occurred in all nine states. CONCLUSIONS: These findings suggest that SARS-CoV-2 may have been introduced into the United States prior to January 19, 2020. |
Assessment of health care exposures and outcomes in adult patients with sepsis and septic shock
Fay K , Sapiano MRP , Gokhale R , Dantes R , Thompson N , Katz DE , Ray SM , Wilson LE , Perlmutter R , Nadle J , Godine D , Frank L , Brousseau G , Johnston H , Bamberg W , Dumyati G , Nelson D , Lynfield R , DeSilva M , Kainer M , Zhang A , Ocampo V , Samper M , Pierce R , Irizarry L , Sievers M , Maloney M , Fiore A , Magill SS , Epstein L . JAMA Netw Open 2020 3 (7) e206004 Importance: Current information on the characteristics of patients who develop sepsis may help in identifying opportunities to improve outcomes. Most recent studies of sepsis epidemiology have focused on changes in incidence or have used administrative data sets that provided limited patient-level data. Objective: To describe sepsis epidemiology in adults. Design, Setting, and Participants: This retrospective cohort study reviewed the medical records, death certificates, and hospital discharge data of adult patients with sepsis or septic shock who were discharged from the hospital between October 1, 2014, and September 30, 2015. The convenience sample was obtained from hospitals in the Centers for Disease Control and Prevention Emerging Infections Program in 10 states (California, Colorado, Connecticut, Georgia, Maryland, Minnesota, New Mexico, New York, Oregon, and Tennessee). Patients 18 years and older with discharge diagnosis codes for severe sepsis or septic shock were randomly selected. Data were analyzed between May 1, 2018, and January 31, 2019. Main Outcomes and Measures: The population's demographic characteristics, health care exposures, and sepsis-associated infections and pathogens were described, and risk factors for death within 30 days after sepsis diagnosis were assessed. Results: Among 1078 adult patients with sepsis (569 men [52.8%]; median age, 64 years [interquartile range, 53-75 years]), 973 patients (90.3%) were classified as having community-onset sepsis (ie, sepsis diagnosed within 3 days of hospital admission). In total, 654 patients (60.7%) had health care exposures before their hospital admission for sepsis; 260 patients (24.1%) had outpatient encounters in the 7 days before admission, and 447 patients (41.5%) received medical treatment, including antimicrobial drugs, chemotherapy, wound care, dialysis, or surgery, in the 30 days before admission. A pathogen associated with sepsis was found in 613 patients (56.9%); the most common pathogens identified were Escherichia coli, Staphylococcus aureus, Klebsiella pneumoniae, and Clostridioides difficile. After controlling for other factors, an association was found between underlying comorbidities, such as cirrhosis (odds ratio, 3.59; 95% CI, 2.03-6.32), immunosuppression (odds ratio, 2.52; 95% CI, 1.81-3.52), vascular disease (odds ratio, 1.54; 95% CI, 1.10-2.15), and 30-day mortality. Conclusions and Relevance: Most adults experienced sepsis onset outside of the hospital and had recent encounters with the health care system. A sepsis-associated pathogen was identified in more than half of patients. Future efforts to improve sepsis outcomes may benefit from examination of health maintenance practices and recent health care exposures as potential opportunities among high-risk patients. |
Supplemental findings of the 2017 National Blood Collection and Utilization Survey
Sapiano MRP , Jones JM , Savinkina AA , Haass KA , Berger JJ , Basavaraju SV . Transfusion 2020 60 Suppl 2 S17-s37 INTRODUCTION: This report provides supplemental results from the 2017 National Blood Collection and Utilization Survey on characteristics of the donor population, autologous and directed donations and transfusions, platelets, plasma and granulocyte transfusions, pediatric transfusions, severe donor-related adverse events, cost of blood units, hospitals policies and practices, and inventory, dosing, and supply. METHODS: Weighting and imputation were used to generate national estimates including number of donors, donations, donor deferrals, autologous and directed donations and transfusions, severe donor-related adverse events, platelet and plasma collections and transfusions, number of cross-match procedures, irradiation and leukoreduction, and pediatric transfusions. RESULTS: Between 2015 and 2017, successful donations decreased slightly by 2.1% with a 10.3% decrease in donations by persons aged 16-18 years and a 14.4% increase in donations by donors aged >65 years. The median price paid for blood components by hospitals decreased from $211 to $207 for leukoreduced red blood cell units, from $523 to $517 for leukoreduced apheresis platelet units, and from $54 to $51 for fresh frozen plasma units. Plasma transfusions decreased 13.6%, but group AB plasma units transfused increased 24.7%. CONCLUSION: Between 2015 and 2017, blood donations declined slightly because of decreases in donations from younger donors, but the number of donations from older donors increased. The price hospitals pay for blood has continued to decrease. Plasma transfusions have decreased, but the proportion of plasma transfusions involving group AB plasma have increased. |
Transfusion-associated adverse events and implementation of blood safety measures - findings from the 2017 National Blood Collection and Utilization Survey
Savinkina AA , Haass KA , Sapiano MRP , Henry RA , Berger JJ , Basavaraju SV , Jones JM . Transfusion 2020 60 Suppl 2 S10-s16 BACKGROUND: Serious transfusion-associated adverse events are rare in the United States. To enhance blood safety, various measures have been developed. With use of data from the 2017 National Blood Collection and Utilization Survey (NBCUS), we describe the rate of transfusion-associated adverse events and the implementation of specific blood safety measures. STUDY DESIGN AND METHODS: Data from the 2017 NBCUS were used with comparison to already published estimates from 2015. Survey weighting and imputation were used to obtain national estimates of transfusion-associated adverse events, and the number of units treated with pathogen reduction technology (PRT), screened for Babesia, and leukoreduced. RESULTS: The rate of transfusion-associated adverse events requiring any diagnostic or therapeutic interventions was stable (275 reactions per 100,000 transfusions in 2015 and 282 reactions per 100,000 transfusions in 2017). In 2017 among US blood collection centers, 16 of 141 (11.3%) reported screening units for Babesia and 28 of 144 (19.4%) reported PRT implementation; 138 of 2279 (6.1%) hospitals reported transfusing PRT-treated platelets. In 2017, 134 of 2336 (5.7%) hospitals reported performing secondary bacterial testing of platelets (50,922 culture-based and 63,220 rapid immunoassay tests); in 2015, 71 of 1877 (3.8%) hospitals performed secondary testing (87,155 culture-based and 21,779 rapid immunoassay tests). Nearly all whole blood/red blood cell units and platelet units were leukoreduced. CONCLUSIONS: Besides leukoreduction, implementation of most blood safety measures reported in this study remains low. Nationally, hospitals might be shifting from culture-based secondary bacterial testing to rapid immunoassays. |
Slowing decline in blood collection and transfusion in the United States - 2017
Jones JM , Sapiano MRP , Savinkina AA , Haass KA , Baker ML , Henry RA , Berger JJ , Basavaraju SV . Transfusion 2020 60 Suppl 2 S1-S9 INTRODUCTION: The National Blood Collection and Utilization Survey (NBCUS) has demonstrated declines in blood collection and transfusion in the United States since 2008, including declines of 11.6% in red blood cell (RBC) collections and 13.9% in RBC transfusions during 2013-2015. This study described the 2017 NBCUS results. METHODS: The 2017 NBCUS was distributed to all US blood collection centers, all hospitals performing at least 1000 surgeries annually, and a 40% random sample of hospitals performing 100 to 999 surgeries annually. Weighting and imputation were used to generate national estimates for units of blood and components collected, deferred, distributed, transfused, and outdated. RESULTS: Response rates for the 2017 NBCUS were 88% for blood collection centers and 86% for transfusing hospitals. Compared with 2015, the number of RBC units collected during 2017 (12,211,000; 95% confidence interval [CI], 11,680,000-12,742,000) declined by 3.0%, and transfused RBC units (10,654,000, 95% CI, 10,314,000-10,995,000) declined by 6.1%. Distributed platelet (PLT) units (2,560,000; 95% CI, 2,391,000-2,730,000 units) increased by 5.1%, and transfused PLT units (1,937,000, 95% CI, 1,794,000-2,079,000) declined by 2.3%. Distributed plasma units (3,209,000; 95% CI, 2,879,000-3,539,000) declined by 13.6%, and transfused plasma units (2,374,000; 95% CI, 2,262,000-2,487,000) declined by 12.9%. CONCLUSION: The 2017 NBCUS suggests a continued but slowing decline in demand for RBCs. The decline in blood collection and use will likely continue. Despite decreasing demand and increasing manufacturing costs of blood products, the US blood industry has met the regular and emergent needs of the country. |
Circumstances involved in unsupervised solid dose medication exposures among young children
Agarwal M , Lovegrove MC , Geller RJ , Pomerleau AC , Sapiano MRP , Weidle NJ , Morgan BW , Budnitz DS . J Pediatr 2020 219 188-195 e6 OBJECTIVE: To identify types of containers from which young children accessed solid dose medications (SDMs) during unsupervised medication exposures and the intended recipients of the medications to advance prevention. STUDY DESIGN: From February to September 2017, 5 US poison centers enrolled individuals calling about unsupervised solid dose medication exposures by children </=5 years. Study participants answered contextually directed questions about exposure circumstances. RESULTS: Sixty-two percent of eligible callers participated. Among 4496 participants, 71.6% of SDM exposures involved children aged </=2 years; 33.8% involved only prescription medications, 32.8% involved only over-the-counter (OTC) products that require child-resistant packaging, and 29.9% involved >/=1 OTC product that does not require child-resistant packaging. More than one-half of exposures (51.5%) involving prescription medications involved children accessing medications that had previously been removed from original packaging, compared with 20.8% of exposures involving OTC products (aOR, 3.39; 95% CI, 2.87-4.00). Attention deficit hyperactivity disorder medications (49.3%) and opioids (42.6%) were often not in any container when accessed; anticonvulsants (41.1%), hypoglycemic agents (33.8%), and cardiovascular/antithrombotic agents (30.8%) were often transferred to alternate containers. Grandparents' medications were involved in 30.7% of prescription medication exposures, but only 7.8% of OTC product exposures (aOR, 3.99; 95% CI, 3.26-4.87). CONCLUSIONS: Efforts to reduce pediatric SDM exposures should also address exposures in which adults, rather than children, remove medications from child-resistant packaging. Packaging/storage innovations designed to encourage adults to keep products within child-resistant packaging and specific educational messages could be targeted based on common exposure circumstances, medication classes, and medication intended recipients. |
Impact of U.S. Public Health Service increased risk deceased donor designation on organ utilization
Sapiano MRP , Jones JM , Bowman J , Levi ME , Basavaraju SV . Am J Transplant 2019 19 (9) 2560-2569 Under U.S. Public Health Service (PHS) guidelines, organ donors with risk factors for human immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C virus (HCV) are categorized as Increased Risk Donors (IRD). Previous studies have suggested that IRD organs are utilized at lower rates than organs from standard risk donors (SRD), but these studies were conducted prior to universal donor nucleic acid test screening. We conducted risk-adjusted analyses to determine the effect of IRD designation on organ utilization using 2010-2017 data (21,626 heart, 101,160 kidney, 52,714 liver and 16,219 lung recipients in the United States) from the Organ Procurement and Transplantation Network. There was no significant difference (p<0.05) between risk-adjusted utilization rates for IRD versus SRD organs for adult hearts and livers and pediatric kidneys, livers, and lungs. Significantly lower utilization was found among IRD adult kidneys, lungs and pediatric hearts. Analysis of the proportion of transplanted organs recovered from IRD by facility suggests that a subset of facilities contribute to the underutilization of adult IRD kidneys. Along with revised criteria and nomenclature to identify donors with HIV, HBV, or HCV risk factors, educational efforts to standardize informed consent discussions might improve organ utilization. This article is protected by copyright. All rights reserved. |
Transfusion-transmitted infections reported to the National Healthcare Safety Network Hemovigilance Module
Haass KA , Sapiano MRP , Savinkina A , Kuehnert MJ , Basavaraju SV . Transfus Med Rev 2019 33 (2) 84-91 Transfusion-transmitted infections (TTIs) can be severe and result in death. Transfusion-transmitted viral pathogen transmission has been substantially reduced, whereas sepsis due to bacterial contamination of platelets and transfusion-transmitted babesiosis may occur more frequently. Quantifying the burden of TTI is important to develop targeted interventions. From January 1, 2010, to December 31, 2016, health care facilities participating in the National Healthcare Safety Network Hemovigilance Module monitored transfusion recipients for evidence of TTI and recorded the total number of units transfused. Facilities use standard criteria to report TTIs. Incidence rates of TTIs, including for bacterial contamination of platelets and transfusion-transmitted babesiosis, are presented. One hundred ninety-five facilities reported 111 TTIs and 7.9 million transfused components to the National Healthcare Safety Network Hemovigilance Module. Of these 111 reports, 54 met inclusion criteria. The most frequently reported pathogens were Babesia spp in RBCs (16/23, 70%) and Staphylococcus aureus in platelets (12/30, 40%). There were 1.95 (26 apheresis, 4 whole blood derived) TTIs per 100000 transfused platelet units and 0.53 TTI per 100000 transfused RBC components, compared to 0.68 TTI per 100000 all transfused components. Bacterial contamination of platelets and transfusion-transmitted babesiosis were the most frequently reported TTIs. Interventions that reduce the burden of bacterial contamination of platelets, particularly collected by apheresis, and Babesia transmission through RBC transfusion would reduce transfusion recipient morbidity and mortality. These analyses demonstrate the value and importance of facility participation in national recipient hemovigilance using standard reporting criteria. |
Is surgical volume still the most accurate indicator of blood usage in the United States
Savinkina A , Sapiano MRP , Berger J , Basavaraju SV . Transfusion 2019 59 (3) 1125-1131 BACKGROUND: Estimates of blood collection and use in the United States derived from the National Blood Collection and Utilization Survey (NBCUS) call for application of robust statistical methods in the analysis of survey data. Since 1993, annual inpatient surgical volume has been used as the main stratification variable for sampling and estimation. However, recent NBCUS results have shown a decrease in blood use in surgical settings, raising the possibility that inpatient surgical volume may no longer be the optimal stratification variable. The objective of this study is to explore factors affecting hospital blood utilization. STUDY DESIGN AND METHODS: A multivariate generalized linear regression with a negative binomial distribution was used to determine which hospital characteristics best explained allogeneic red blood cell (RBC) use, using data from the 2015 NBCUS to determine hospital blood use and the 2013 annual American Hospital Association database to identify hospital characteristics. RESULTS: Annual inpatient surgical volume explained the most variation in allogeneic RBC use among hospitals (pseudo-R(2) of 70.8%). Additional variables, such as presence of an oncology service, were also statistically significant in the models but explained little additional variability in blood use. CONCLUSION: These findings suggest that annual inpatient surgical volume is an appropriate indicator for estimating blood utilization in the United States. As trends in blood utilization continue to evolve, ongoing analytic efforts to understand indicators of blood use are necessary. |
US emergency department visits for adverse drug events from antibiotics in children, 2011-2015
Lovegrove MC , Geller AI , Fleming-Dutra KE , Shehab N , Sapiano MRP , Budnitz DS . J Pediatric Infect Dis Soc 2018 8 (5) 384-391 Background: Antibiotics are among the most commonly prescribed medications for children; however, at least one-third of pediatric antibiotic prescriptions are unnecessary. National data on short-term antibiotic-related harms could inform efforts to reduce overprescribing and to supplement interventions that focus on the long-term benefits of reducing antibiotic resistance. Methods: Frequencies and rates of emergency department (ED) visits for antibiotic adverse drug events (ADEs) in children were estimated using adverse event data from the National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance project and retail pharmacy dispensing data from QuintilesIMS (2011-2015). Results: On the basis of 6542 surveillance cases, an estimated 69464 ED visits (95% confidence interval, 53488-85441) were made annually for antibiotic ADEs among children aged </=19 years from 2011 to 2015, which accounts for 46.2% of ED visits for ADEs that results from systemic medication. Two-fifths (40.7%) of ED visits for antibiotic ADEs involved a child aged </=2 years, and 86.1% involved an allergic reaction. Amoxicillin was the most commonly implicated antibiotic among children aged </=9 years. When we accounted for dispensed prescriptions, the rates of ED visits for antibiotic ADEs declined with increasing age for all antibiotics except sulfamethoxazole-trimethoprim. Amoxicillin had the highest rate of ED visits for antibiotic ADEs among children aged </=2 years, whereas sulfamethoxazole-trimethoprim resulted in the highest rate among children aged 10 to 19 years (29.9 and 24.2 ED visits per 10000 dispensed prescriptions, respectively). Conclusions: Antibiotic ADEs lead to many ED visits, particularly among young children. Communicating the risks of antibiotic ADEs could help reduce unnecessary prescribing. Prevention efforts could target pediatric patients who are at the greatest risk of harm. |
Assessing variability in hospital-level mortality among U.S. Medicare beneficiaries with hospitalizations for severe sepsis and septic shock
Hatfield KM , Dantes RB , Baggs J , Sapiano MRP , Fiore AE , Jernigan JA , Epstein L . Crit Care Med 2018 46 (11) 1753-1760 OBJECTIVES: To assess the variability in short-term sepsis mortality by hospital among Centers for Medicare and Medicaid Services beneficiaries in the United States during 2013-2014. DESIGN: A retrospective cohort design. SETTING: Hospitalizations from 3,068 acute care hospitals that participated in the Centers for Medicare and Medicaid Services inpatient prospective payment system in 2013 and 2014. PATIENTS: Medicare fee-for-service beneficiaries greater than or equal to 65 years old who had an inpatient hospitalization coded with present at admission severe sepsis or septic shock. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Individual level mortality was assessed as death at or within 7 days of hospital discharge and aggregated to calculate hospital-level mortality rates. We used a logistic hierarchal linear model to calculate mortality risk-adjusted for patient characteristics. We quantified variability among hospitals using the median odds ratio and calculated risk-standardized mortality rates for each hospital. The overall crude mortality rate was 34.7%. We found significant variability in mortality by hospital (p < 0.001). The middle 50% of hospitals had similar risk-standardized mortality rates (32.7-36.9%), whereas the decile of hospitals with the highest risk-standardized mortality rates had a median mortality rate of 40.7%, compared with a median of 29.2% for hospitals in the decile with the lowest risk-standardized mortality rates. The median odds ratio (1.29) was lower than the adjusted odds ratios for several measures of patient comorbidities and severity of illness, including present at admission organ dysfunction, no identified source of infection, and age. CONCLUSIONS: In a large study of present at admission sepsis among Medicare beneficiaries, we showed that mortality was most strongly associated with underlying comorbidities and measures of illness on arrival. However, after adjusting for patient characteristics, mortality also modestly depended on where a patient with sepsis received care, suggesting that efforts to improve sepsis outcomes in lower performing hospitals could impact sepsis survival. |
National estimates of emergency department visits for antibiotic adverse events among adults - United States, 2011-2015
Geller AI , Lovegrove MC , Shehab N , Hicks LA , Sapiano MRP , Budnitz DS . J Gen Intern Med 2018 33 (7) 1060-1068 BACKGROUND: Detailed, nationally representative data describing high-risk populations and circumstances involved in antibiotic adverse events (AEs) can inform approaches to prevention. OBJECTIVE: Describe US burden, rates, and characteristics of emergency department (ED) visits by adults for antibiotic AEs. DESIGN: Nationally representative, public health surveillance of adverse drug events (National Electronic Injury Surveillance System-Cooperative Adverse Drug Event Surveillance [NEISS-CADES]) and a nationally projected database of dispensed prescriptions (QuintilesIMS), 2011-2015. PATIENTS: Antibiotic-treated adults (>/= 20 years) seeking ED care. MAIN MEASURES: Estimated annual numbers and rates of ED visits for antibiotic AEs among outpatients treated with systemically administered antibiotics. KEY RESULTS: Based on 10,225 cases, US adults aged >/= 20 years made an estimated 145,490 (95% confidence interval, 115,279-175,701) ED visits for antibiotic AEs each year in 2011-2015. Antibiotics were implicated in 13.7% (12.3-15.2%) of all estimated adult ED visits for adverse drug events. Most (56.6%; 54.8-58.4%) antibiotic AE visits involved adults aged < 50 years, and 71.8% (70.4-73.1%) involved females. Accounting for prescriptions dispensed from retail and long-term care pharmacies, adults aged 20-34 years had twice the estimated rate of ED visits for oral antibiotic AEs compared with those aged >/= 65 years (9.7 [7.6-11.8] versus 4.6 [3.6-5.7] visits per 10,000 dispensed prescriptions, respectively). Allergic reactions accounted for three quarters (74.3%; 70.0-78.6%) of estimated ED visits for antibiotic AEs. The three most frequently implicated antibiotic classes in ED visits for antibiotic AEs were oral sulfonamides (23.2%; 20.6-25.8%), penicillins (20.8%; 19.3-22.4%), and quinolones (15.7%; 14.2-17.1%). Per-prescription rates declined with increasing age group. CONCLUSIONS: Antibiotics are a common cause of ED visits by adults for adverse drug events and represent an important safety issue. Quantifying risks of AEs from specific antibiotics for specific patient populations, such as younger adults, provides additional information to help clinicians assess risks versus benefits when making the decision to prescribe or not prescribe an antibiotic. AE rates may also facilitate communication with patients about antibiotic risks. |
Primary care provider perceptions and practices regarding dosing units for oral liquid medications
Lovegrove MC , Sapiano MRP , Paul IM , Yin HS , Wilkins TL , Budnitz DS . Acad Pediatr 2017 18 (4) 405-408 INTRODUCTION: To prevent errors, healthcare professional and safety organizations recommend using milliliters (mL) alone for oral liquid medication dosing instructions and devices. In 2018, for federal incentives under the Quality Payment Program, one requirement is for Electronic Health Records (EHRs) to automatically use mL alone whenever oral liquid medications are prescribed. Current perceptions and practices of primary care providers (PCPs) regarding dosing units for oral liquid medications were assessed. METHODS: Pediatricians, family practitioners, nurse practitioners, and internists participating in the 2015 DocStyles web-based survey were asked about their perceptions and practices regarding dosing units for oral liquid medications. RESULTS: Three-fifths of PCPs (59.0%) reported that using mL alone is safest for dosing oral liquid medications; however, nearly three-quarters (72.0%) thought that patients/caregivers prefer instructions that include spoon-based units. Within each specialty, fewer PCPs reported they would prescribe using mL alone than reported that using mL alone is safest (P<.0001 for all). Among PCPs who think mL-only dosing is safest, those who perceived patients/caregivers prefer spoon-based units were less likely to prescribe using mL alone (odds ratio: 0.45, 95% CI: 0.34-0.59). Pediatricians were more likely than other PCPs to report that it is safest to use mL alone (80.8% vs 54.7%) and that they would use mL alone when prescribing (56.8% vs 30.9%) (P<.0001 for both). CONCLUSIONS: Because fewer than two-thirds of pediatricians and one-third of other PCPs would use mL alone in dosing instructions, additional education to encourage prescribing and communicating with patients/caregivers using mL alone may be needed. |
Cost projections for implementation of safety interventions to prevent transfusion-transmitted Zika virus infection in the United States.
Ellingson KD , Sapiano MRP , Haass KA , Savinkina AA , Baker ML , Henry RA , Berger JJ , Kuehnert MJ , Basavaraju SV . Transfusion 2017 57 Suppl 2 1625-1633 BACKGROUND: In August 2016, the Food and Drug Administration advised US blood centers to screen all whole blood and apheresis donations for Zika virus (ZIKV) with an individual-donor nucleic acid test (ID-NAT) or to use approved pathogen reduction technology (PRT). The cost of implementing this guidance nationally has not been assessed. STUDY DESIGN AND METHODS: Scenarios were constructed to characterize approaches to ZIKV screening, including universal ID-NAT, risk-based seasonal allowance of minipool (MP) NAT by state, and universal MP-NAT. Data from the 2015 National Blood Collection and Utilization Survey (NBCUS) were used to characterize the number of donations nationally and by state. For each scenario, the estimated cost per donor ($3-$9 for MP-NAT, $7-$13 for ID-NAT) was multiplied by the estimated number of relevant donations from the NBCUS. Cost of PRT was calculated by multiplying the cost per unit ($50-$125) by the number of units approved for PRT. Prediction intervals for costs were generated using Monte Carlo simulation methods. RESULTS: Screening all donations in the 50 states and DC for ZIKV by ID-NAT would cost $137 million (95% confidence interval [CI], $109-$167) annually. Allowing seasonal MP-NAT in states with lower ZIKV risk could reduce NAT screening costs by 18% to 25%. Application of PRT to all platelet (PLT) and plasma units would cost $213 million (95% CI, $156-$304). CONCLUSION: Universal ID-NAT screening for ZIKV will cost US blood centers more than $100 million annually. The high cost of PRT for apheresis PLTs and plasma could be mitigated if, once validated, testing for transfusion transmissible pathogens could be eliminated. |
Supplemental findings from the National Blood Collection and Utilization Surveys, 2013 and 2015
Sapiano MRP , Savinkina AA , Ellingson KD , Haass KA , Baker ML , Henry RA , Berger JJ , Kuehnert MJ , Basavaraju SV . Transfusion 2017 57 Suppl 2 1599-1624 The largest change in RBC use between 2013 and 2015 occurred in surgical settings, with a statistically significant decrease of 41.5%. RBC use was unchanged from 2013 to 2015 in critical care and emergency department settings. There was a statistically significant increase in the number of PLT units used in critical care settings, however, there were no statistically significant changes in PLT use in other settings. | The number of donations and donors presenting for donation have decreased steadily since 2011. In 2013 and 2015, a greater proportion of donors were <18 years of age (13.4% in 2015), ≥65 years of age (12.4% in 2015), and repeat donors (63.6% in 2015). | Prices paid per unit decreased for all major component categories between 2013 and 2015, with statistically significant declines in price paid per unit for leukoreduced red blood cells (median price per unit: $211 in 2015; $221 in 2013), and apheresis PLTs (median price per unit: $524 in 2015; $540 in 2013). Higher surgical volume hospitals paid the lowest prices per unit across component types. | ADDITIONAL FINDINGS | Rates of adverse recipient reactions requiring any diagnostic or therapeutic intervention out of all transfusions were similar between 2013 (1:363) and 2051 (1:373), although there was an increase in the observed rate of reactions that were life threatening (1:41,874 in 2013 and 1:10,925 in 2015). | In 2015, relative parity between donor adverse reaction rates was observed for manual (1:854) and automated (1:786) collections in blood centers and automated collections (1:752) in hospital-based blood centers. There was a higher reaction rate for manual collections (1:237) in hospital-based blood centers. | In 2015, 2% of hospitals and 19% of blood centers reported genotyping for RBC antigens, although at these facilities a small proportion of all units were typed. |
Continued decline in blood collection and transfusion in the United States-2015
Ellingson KD , Sapiano MRP , Haass KA , Savinkina AA , Baker ML , Chung KW , Henry RA , Berger JJ , Kuehnert MJ , Basavaraju SV . Transfusion 2017 57 Suppl 2 1588-1598 BACKGROUND: In 2011 and 2013, the National Blood Collection and Utilization Survey (NBCUS) revealed declines in blood collection and transfusion in the United States. The objective of this study was to describe blood services in 2015. STUDY DESIGN AND METHODS: The 2015 NBCUS was distributed to all US blood collection centers, all hospitals performing at least 1000 surgeries annually, and a 40% random sample of hospitals performing 100 to 999 surgeries annually. Weighting and imputation were used to generate national estimates for units of blood and components collected, deferred, distributed, transfused, and outdated. RESULTS: Response rates for the 2015 NBCUS were 78.4% for blood collection centers and 73.9% for transfusing hospitals. In 2015, 12,591,000 units of red blood cells (RBCs) (95% confidence interval [CI], 11,985,000-13,197,000 units of RBCs) were collected, and 11,349,000 (95% CI, 10,592,000-11,747,000) were transfused, representing declines since 2013 of 11.6% and 13.9%, respectively. Total platelet units distributed (2,436,000; 95% CI, 2,230,000-2,642,000) and transfused (1,983,000; 95% CI, 1,816,000 = 2,151,000) declined by 0.5% and 13.1%, respectively, since 2013. Plasma distributions (3,714,000; 95% CI, 3,306,000-4,121,000) and transfusions (2,727,000; 95% CI, 2,594,000-2,859,000) in 2015 declined since 2013. The median price paid per unit in 2015-$211 for leukocyte-reduced RBCs, $524 for apheresis platelets, and $54 for fresh frozen plasma-was less for all components than in 2013. CONCLUSIONS: The 2015 NBCUS findings suggest that continued declines in demand for blood products resulted in fewer units collected and distributed Maintaining a blood inventory sufficient to meet routine and emergent demands will require further monitoring and understanding of these trends. |
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