Process capability indexes: Trends and developments in the manufacturing of blood components.

The production of blood components takes place in a workflow where conditions should be controlled and stabilized. The quality control claims and the principles of statistical process control should be understood to apply a control policy properly. Control typically employs charts complemented by a set of rules that allow taking well-supported actions. The use of capability indexes is not systematically used in blood establishments. They allow characterizing the production process. The data analyzed refer to producing a type of blood component over three years in two blood establishments. One or more capability levels may be typical of a given analyte for a specific blood component in a given environment. Some recommendations for adequate use of capability indexes to control blood components production properly are assumed.

Supplemental findings of the 2019 National Blood Collection and Utilization Survey.

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.

Has the trend of declining blood transfusions in the United States ended? Findings of the 2019 National Blood Collection and Utilization Survey.

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.

Blood component utilization in COVID-19 patients in New York City: Transfusions do not follow the curve.

BACKGROUND: Blood suppliers and transfusion services have worked diligently to maintain an adequate blood supply during the COVID-19 pandemic. Our experience has shown that some COVID-19 inpatients require transfusion support; understanding this need is critical to blood product inventory management. STUDY DESIGN AND METHODS: Hospital-wide and COVID-19 specific inpatient blood product utilization data were collected retrospectively for our network's two tertiary academic medical centers over a 9-week period (March 1, 2020-May 2, 2020), when most inpatients had COVID-19. Utilization data were merged with a COVID-19 patient database to investigate clinical demographic characteristics of transfused COVID-19 inpatients relative to non-transfused ones. RESULTS: Overall, 11 041 COVID-19 patients were admitted and 364 received blood product transfusions for an overall transfusion rate of 3.3%. COVID-19 patients received 1746 blood components in total, the majority of which were red blood cells. COVID-19 patients' weekly transfusion rate increased as the pandemic progressed, possibly reflecting their increased severity of illness. Transfusion was significantly associated with several indicators of severe disease, including mortality, intubation, thrombosis, longer hospital admission, lower hemoglobin and platelet nadirs, and longer prothrombin and activated partial thromboplastin times. As the pandemic progressed, institutional adherence to transfusion guidelines improved for RBC transfusions compared to prior year trends but did not improve for platelets or plasma. CONCLUSION: There is a need to closely monitor the blood product inventory and demand throughout the COVID-19 pandemic as patients' transfusion needs may increase over time. Daily or weekly trending of patients' clinical status and laboratory values may assist blood banks in inventory management.

A 0.6-protamine/heparin ratio in cardiac surgery is associated with decreased transfusion of blood products.

OBJECTIVES: In cardiac surgery, adequate heparinization is necessary to prevent thrombus formation in the cardiopulmonary bypass (CPB). To counteract the heparin effect after weaning from CPB, protamine is administered. The optimal protamine/heparin ratio is still unknown. METHODS: In this before-after study, we evaluated the effect of a 0.6/1-protamine/heparin ratio implementation as of May 2017 versus a 0.8/1-protamine/heparin ratio on the 12-h postoperative blood loss and the amount of blood and blood component transfusions (fresh frozen plasma, packed red blood cells, fibrinogen concentrate, platelet concentrate and prothrombin complex concentrate) after cardiac surgery. A total of 2051 patients who underwent cardiac surgery requiring CPB between May 2016 and May 2018 were included. RESULTS: In the 0.6/1-protamine/heparin ratio group, only 28.8% of the patients received blood component transfusion, compared to 37.9% of the patients in the 0.8/1-ratio group (P < 0.001). The median 12-h postoperative blood loss was 230 ml (interquartile range 140-320) in the 0.6/1-ratio group versus 260 ml (interquartile range 155-365) in the 0.8/1-ratio group (P < 0.001). CONCLUSIONS: A 0.6/1-protamine/heparin ratio after weaning from CPB is associated with a significantly reduced 12-h postoperative blood loss and blood components transfusion.

Contemporary resuscitation of hemorrhagic shock: What will the future hold?

Resuscitation of the critically ill patient with fluid and blood products is one of the most widespread interventions in medicine. This is especially relevant for trauma patients, as hemorrhagic shock remains the most common cause of preventable death after injury. Consequently, the study of the ideal resuscitative product for patients in shock has become an area of great scientific interest and investigation. Recently, the pendulum has swung towards increased utilization of blood products for resuscitation. However, pathogens, immune reactions and the limited availability of this resource remain a challenge for clinicians. Technologic advances in pathogen reduction and innovations in blood product processing will allow us to increase the safety profile and efficacy of blood products, ultimately to the benefit of patients. The purpose of this article is to review the current state of blood product based resuscitative strategies as well as technologic advancements that may lead to safer resuscitation.

Whole blood transfusion versus component therapy in adult trauma patients with acute major haemorrhage.

OBJECTIVE: In the era of damage control resuscitation of trauma patients with acute major haemorrhage, transfusion practice has evolved to blood component (component therapy) administered in a ratio that closely approximates whole blood (WB). However, there is a paucity of evidence supporting the optimal transfusion strategy in these patients. The primary objective was therefore to establish if there is an improvement in survival at 30 days with the use of WB transfusion compared with blood component therapy in adult trauma patients with acute major haemorrhage. METHODOLOGY: A systematic literature search was performed on 15 December 2019 to identify studies comparing WB transfusion with component therapy in adult trauma patients and mortality at 30 days. Studies which did not report mortality were excluded. Methodological quality of included studies was interpreted using the Cochrane risk of bias tool, and rated using the Grading of Recommendations Assessment, Development and Evaluation approach. RESULTS: Search of the databases identified 1885 records, and six studies met the inclusion criteria involving 3255 patients. Of the three studies reporting 30-day mortality (one randomised controlled trial (moderate evidence) and two retrospective (low and very low evidence, respectively)), only one study demonstrated a statistically significant difference between WB and component therapy, and two found no statistical difference. Two retrospective studies reporting in-hospital mortality found no statistical difference in unadjusted mortality, but both reported statistically significant logistic regression analyses demonstrating that those with a WB transfusion strategy were less likely to die. CONCLUSION: Recognising the limitations of this systematic review relating to the poor-quality evidence and limited number of included trials, it does not provide evidence to support or reject use of WB transfusion compared with component therapy for adult trauma patients with acute major haemorrhage. PROSPERO REGISTRATION NUMBER: CRD42019131406.

Secular trends in the distribution of allogeneic blood components in Taiwan.

Recent blood distribution profiles for transfusions in Taiwan have not been comprehensively documented. This study aimed to analyze trends in red blood cell (RBC), platelet, and plasma distribution rates, and compares these profiles with those in other countries. The distribution rates of RBC, platelets, and plasma in Taiwan during 2015 were 47.6, 11.1, and 26.8 units per 1000 population, respectively. At least 1.5 and 2.5-fold higher platelet and plasma distribution rates were observed than other selected countries. During 2007-2015, there was no significant change in RBC distribution. However, we observed a significant increase of 0.20 (95% CI: 0.11-0.30) adult doses of platelets, and a significant decrease of 1.69 (95% CI: 1.45-1.93) units of plasma per 1000 population per annum. Seven other countries showed a general significant decreasing trend of RBC distributions. Higher blood distribution rates were observed in Taiwan. Therefore, the adoption of patient blood management is essential.

Transfusion trends in hip arthroplasty in Korea: a nationwide study by the Korean National Health Insurance Service.

BACKGROUND: Hip arthroplasties are strongly associated with blood transfusion to compensate for perioperative bleeding. The purpose of this study was to evaluate the trends in transfusion associated with hip arthroplasties, using nationwide data supplied by the National Health Insurance Service. STUDY DESIGN AND METHODS: We used data from nationwide claims database of the Health Insurance Review Assessment Service. The data managed by the National Health Insurance Service were used to identify 161,934 hip arthroplasties under three categories, including bipolar hemiarthroplasty, total hip arthroplasty, and revision arthroplasty, from 2007 to 2015. The transfusion rates, transfusion amounts, the proportion of transfusion, and cost associated with each type of operation were investigated and stratified according to age, sex, hospital type, and region. RESULTS: The proportion of patients receiving any allogeneic transfusion was 81.1% in 9 years. The overall proportion of transfusion was 7% fresh frozen plasma, 12% platelets, and 77% RBCs. The average count of transfusions was 4.1 in bipolar hemiarthroplasty (343,815/83,729), 4.3 in total hip arthroplasty (196,869/46,097), and 8.7 in revision arthroplasty (35,044/4,024) from 2007 to 2015. CONCLUSION: In this nationally representative study of trends in transfusion associated with hip arthroplasty, we observed significantly high rates of blood transfusion among patients undergoing hip arthroplasties. Although the overall amount of transfusion declined, the allogeneic transfusion rate was still high from 2007 to 2015 in Korea, and higher than other countries are reporting.

Trends in transfusion practice over 20 years in paediatric liver transplant programme.

BACKGROUND: We investigated changes to transfusion practices over time in paediatric liver transplant centre and evaluated the effect of transfusion practice to mortality. METHODS: A pilot retrospective study included two cohorts each with 101 sequential paediatric LT recipients: an Early group (1994-1998) and a Recent group (2009-2013). Demographic characteristics and data on the intraoperative transfusion of red blood cells (RBC), fresh-frozen plasma (FFP), platelets and cryoprecipitate were collected. Postoperative laboratory results were also obtained, together with donor and data regarding 1- and 5-year survival. Appropriate intergroup comparisons, univariate and multivariate analysis were made and P ≤ 0·05 was considered statistically significant. RESULTS: There were no significant group differences in demographic data (except patient height). Despite the fact that median total blood loss did not differ between groups (111 ml/kg in both groups), the Early group had greater levels of intraoperative RBC transfusion (75 vs. 59 ml/kg, respectively, P = 0·04) and less use of FFP (53 vs. 62 ml/kg, respectively, P = 0·01). Overall we noted a lower 1- and 5-year survival in the Early group (88·2% vs. 96%, P = 0·04 and 82·4% vs. 89·1%, P = 0·01, respectively). Univariate, but not multivariate regression analyses demonstrated that higher PELD score, RBC and FFP transfusion, and inclusion in the Early group were contributing factors to 1-year higher mortality. CONCLUSIONS: This retrospective analysis of blood loss and replacement in paediatric LT patients demonstrates that the majority of our patients suffer major haemorrhage and require large-volume RBC and FFP replacements. In our pilot study, large volume of RBC and FFP replacement did not contribute to mortality. Paediatric LT involves a number of multidisciplinary teams. Thus, all care-related factors and combinations thereof that may contribute to outcome and should be evaluated in the future.

Trends and outcomes in multicomponent blood transfusion: an 11-year cohort study of a large multisite academic center.

BACKGROUND: Most studies reporting on blood component utilization overlook patients transfused with more than one type of blood product (multicomponent transfusion). These patients are of importance, as they are large consumers of blood products and likely have different characteristics and outcomes than nontransfused patients and patients transfused with only one blood component type. Our study aimed to determine the prevalence of multicomponent transfusion at a large multisite academic center, as well as the patient characteristics and outcomes associated with multicomponent transfusion. METHODS: A retrospective cohort study of transfused adult inpatients at the Ottawa Hospital between 2007 and 2017 was performed. Eligible transfusions were red blood cells (RBCs), platelets, plasma, cryoprecipitate, and/or fibrinogen concentrate. Descriptive analyses were done to determine multicomponent transfusion prevalence. Patient characteristics and outcomes associated with multicomponent transfusion were assessed using multivariable regressions. RESULTS: Of 55,719 adult transfused inpatient admissions, 25% received a multicomponent transfusion. Multicomponent transfusion prevalence was highest in hematology (51%), cardiac surgery (45%), and critical care (40%) patients. Multivariable regression analysis showed that compared to RBC-only transfusion, multicomponent transfusion was associated with increased odds of in-hospital mortality (odds ratio, 3.48; 95% confidence interval [CI], 3.26-3.73), greater odds of institutional discharge as opposed to discharge home (odds ratio, 1.22; 95% CI, 1.15-1.30), and a 1.58 time increase in duration of hospitalization (95% CI, 1.54-1.62). CONCLUSION: Multicomponent transfusion recipients make up a large proportion of transfused patients and have poorer outcomes. It is necessary to continue studying these patients, including outcomes and transfusion appropriateness, to inform best practices.

Changes in plasma unit distributions to hospitals over a 10-year period.

BACKGROUND: There are many influences on a hospital's demand for plasma. Pharmaceuticals are now being administered for many indications instead of plasma, although trauma resuscitation now emphasizes increased and early intervention with plasma. This multinational study evaluated changes in blood center plasma unit distributions over a 10-year period. STUDY DESIGN AND METHODS: Data on the total number and the ABO groups of plasma unit distributions were obtained from nine American blood collectors (ABCs) and nine national or provincial blood services (NPBS) from 2007 through 2016. Plasma distributions to trauma hospitals by five ABCs and four NPBS were also analyzed. RESULTS: The overall number of plasma unit distributions from ABCs decreased by 23.1% from 2007 to 2016, but the relative proportion of distributed AB plasma units increased during the same period. The NPBS (excluding the Japanese Red Cross [JRC]) also had a 35.4% decrease in the overall number of plasma unit distributions with an increase in the relative proportion of AB plasma distributions between 2007 and 2016. The JRC, however, reported an increase in the overall number of plasma distributions by 13.5% in 2016 compared to 2007. The proportion of low-titer A plasma distributions increased to 1.6% of total plasma distributions by ABCs in 2016. There was a trend of distributing increasing proportions of group AB plasma units to trauma hospitals over the 10-year period. CONCLUSION: Although the number of plasma unit distributions has decreased at many blood collectors over time, the proportion of AB units has increased at both ABCs and NPBS.

Blood derived products in pediatrics: New laboratory tools for optimizing potency assignment and reducing side effects.

Neonates and children can develop rare bleeding disorders due to congenital/acquired coagulation Factor deficiencies, or allo-immune/autoimmune complications, or can undergo surgeries at high haemorrhagic risk. They then need specialized transfusion of blood components/products, or purified blood extracted products or recombinant proteins. Blood-derived therapies conventionally used for management of affected infants with genetic/acquired deficiencies, bleeding problems (coagulation Factor reduced or missing) or thrombotic disorders (reduced or missing anticoagulant proteins) pose some additional risks. These remedial therapies can cause tolerance when used very early in life and, sometimes needed, repeatedly. The introduction of recombinant proteins has allowed manufacturers to produce large amounts of the proteins usually present at very low concentration in blood. This has also changed the risk pattern of plasma-extracted products, especially in terms of continual reduction of viral transmission. Many efforts have been made over these past decades to reduce the risks associated with the use of all these products in terms of viral and bacterial safety, as well as immune disorders but they are not the objective of this article. Other associated side effects are the presence of undesired activities in blood products, which can produce thrombotic events or adverse reactions. The progressive introduction of blood derived products has greatly improved the prognosis and quality of life of affected patients. This concerns whole blood, but also blood cell concentrates, mainly platelets and red blood cells, plasma, while the blood extracted products are increasingly replaced by recombinant proteins. All these therapeutic products, i.e. blood extracted drugs, improve health and quality of life for hemophiliac's A or B, or patients with auto/allo-immune thrombocytopenias or with rare bleeding disorders, and those with thrombotic events occurring in childhood, which are mainly due to Protein C or Protein S deficiencies (congenital or acquired). Progress in analytical methods and biotechnology allow better control of the manufacturing processes for all blood derived or plasma extracted products and recombinant proteins, and contribute to improved manufacturing processes to minimize the occurrence of side effects. These adverse events can be due to the aging of the blood cell concentrate with release of their granule content, and generation of EVs, which can produce anaphylactic reactions and risk of thrombosis, but also to the presence of activated coagulation Factors in purified products, such as Factor Xia as recently identified in immunoglobulin concentrates. Characterization and measurement of contaminant products is of special usefulness during product preparation and for optimization of manufacturing processes for purified extracted products, but also for recombinant proteins. The pharmaceutical industry introduces these new methods for validating manufacturing processes, or for quality control assessments. The objective is first to warrant the full quality and safety of the lots produced, and assure the highest efficacy with the lowest risks when used in patients. For cell concentrates and fresh blood, storage conditions are critical and measurement of analytes such as EVs or Annexin V allows evaluation of quality of each individual transfused pouch. In addition to all the rules around viral and bacterial transmission risk, and immune tolerance, our available laboratory methods contribute to reducing the side effects of blood cell concentrates and derived plasma products, as well as those of the therapeutic recombinant proteins.

The dynamics of contract plasma fractionation.

Plasma Derived Medicinal Products (PMDPs) are an essential component of the modern therapeutic armamentarium. They are differentiated from most other medicines in several ways, particularly the unique nature of the raw material used for their manufacture. Human plasma has been fractionated to PDMPs for the past 75 years, and the economics of manufacturing requires currently that as many products are harvested from each litre as is feasible and reflective of clinical needs. PDMPs may be purchased on the open market from the various commercial and not-for-profit (NFP) manufacturers. They may also be manufactured under contract (CM) from plasma supplied by government and similar agencies as a product of blood transfusion services. Clients for CM aspire to make full use of donated plasma, hence maximizing the donors' gift after the standard components of transfusion have been harvested. Many such countries also aspire to making their national clinical needs self-sufficient in PDMPs, attempting to acquire strategic independence from the vagaries of the commercial open market. The increasing commercial imperatives operating in the PMDP sector generate a tension with such ethical aspirations which are not easily resolved. In particular, the need to harvest as many proteins as possible may generate products which are surplus to national needs, necessitating an ethical paradigm for the optimal provision of such products. In addition, traditional relationships between blood services and domestic fractionation agencies may come under stress as a result of the competitive processes underpinning such transactions, which are now subject to international norms of free trade. Blood services engaged in the supply of hospital transfusion components are detached from the pharmaceutical Good Manufacturing Practices (GMP) culture needed for the production of plasma for CM, while the generation of such plasma through extraction from whole blood donations deflects the focus from that of a dedicated raw material for CM to a byproduct of the donation process. We review the field of CM, assess the current tensions within the sector, and offer suggestions for the strategic positioning of governments and other clients to ensure optimal outcomes for all the stakeholders involved.

[Changes in consumption of blood products in Finland from 2007 to 2014]. / Verivalmisteiden kulutuksen muutokset Suomessa vuosina 2007-2014.

The Finnish Red Cross Blood Service (FRCBS) collects and distributes all cellular blood products in Finland. The use of red cells in Finland follows neither the aging of the Finnish population nor morbidity. The use of red blood cells has diminished 34% during the last 20 years and half of this decrease has taken place during the last three years. Use of platelet preparations per inhabitant in Finland clearly exceeds European median. An enhanced IT support for the blood supply chain is needed to maximize the effectiveness of use of blood products.

Plasma Transfusion: History, Current Realities, and Novel Improvements.

Traumatic hemorrhage is the leading cause of preventable death after trauma. Early transfusion of plasma and balanced transfusion have been shown to optimize survival, mitigate the acute coagulopathy of trauma, and restore the endothelial glycocalyx. There are a myriad of plasma formulations available worldwide, including fresh frozen plasma, thawed plasma, liquid plasma, plasma frozen within 24 h, and lyophilized plasma (LP). Significant equipoise exists in the literature regarding the optimal plasma formulation. LP is a freeze-dried formulation that was originally developed in the 1930s and used by the American and British military in World War II. It was subsequently discontinued due to risk of disease transmission from pooled donors. Recently, there has been a significant amount of research focusing on optimizing reconstitution of LP. Findings show that sterile water buffered with ascorbic acid results in decreased blood loss with suppression of systemic inflammation. We are now beginning to realize the creation of a plasma-derived formulation that rapidly produces the associated benefits without logistical or safety constraints. This review will highlight the history of plasma, detail the various types of plasma formulations currently available, their pathophysiological effects, impacts of storage on coagulation factors in vitro and in vivo, novel concepts, and future directions.

Trends in United States blood collection and transfusion: results from the 2013 AABB Blood Collection, Utilization, and Patient Blood Management Survey.

BACKGROUND: AABB surveyed AABB institutional members about their 2013 blood collection, transfusion, and patient blood management (PBM) programs. Results were compared with previous US national surveys. STUDY DESIGN AND METHODS: The 2013 AABB Blood Collection, Utilization, and Patient Blood Management Survey was distributed to AABB blood centers (79) and hospitals (1068). Statistical procedures were used to estimate blood collection and transfusion. RESULTS: Estimated whole blood (WB) and red blood cell (RBC) collections in 2013 totaled 13.6 million units, a 12.1% decrease from 15.5 million units in 2011 (p < 0.0001). Transfusions of WB and RBC units by AABB hospitals totaled 6.1 million units, 7.3% fewer compared to 2011 (p = 0.036). There was no change in overall platelet (PLT) distributions by blood collectors but WB-derived (WBD) PLT distributions increased significantly (27.1%, p < 0.0001). Transfusion of PLTs increased 15.4% totaling 1.3 million units (p = 0.0423), including increases in apheresis PLT (12.2%) and WBD PLT transfusions (30.7%). Distribution of plasma for transfusion declined 22.4% (p < 0.0001), while transfused plasma decreased only 9.9% (p = 0.036). Hospitals reduced outdated WB, RBC, and PLT components by 14.9% to 26.1% and wasted plasma components by 19.0%. PBM programs were reported by 37.8% of AABB hospitals. CONCLUSIONS: Compared to 2011, WB and RBC collections declined significantly in 2013 and disproportionately to the significant reductions in WB and RBC transfusions. Distributions of PLTs and plasma for transfusion declined in 2013, as did transfusions of plasma, while transfusion of PLTs increased significantly. Decreases in outdated and wasted components by hospitals suggest improvements in product and inventory management. Ongoing national surveys allow for trend analysis and are important for future planning.

Declining blood collection and utilization in the United States.

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 utilization. STUDY DESIGN AND METHODS: The 2013 Department of Health and Human Services NBCUS is a cross-sectional survey of all US blood collection centers and hospitals as listed in the 2012 American Hospital Association Annual Survey database that perform at least 100 inpatient surgical procedures annually. The study objective was to estimate, with 95% confidence intervals (CIs), the number of blood and blood components collected and transfused in the United States. RESULTS: In 2013, a total of 14,237,000 whole blood and apheresis red blood cell (RBC) units (95% CI, 13,639,000-14,835,000) were collected with 13,395,000 available for transfusion. Of these, 13,180,000 (95% CI, 12,389,000-13,972,000) whole blood and RBC units were transfused. This represented a 4.4% decline in the number of transfused units compared to 2011. Outdated (i.e., expired without being transfused) whole blood and RBC units declined by 17.3%. Apheresis (2,318,000; 95% CI, 2,154,000-2,482,000) and whole blood-derived platelet (PLT; 130,000; 95% CI, 23,000-237,000) distribution declined in 2013. Total PLT transfusions increased in 2013 (2,281,000) in comparison to 2011 (2,169,000). Total plasma units distributed (4,338,000) and transfused (3,624,000) declined. CONCLUSION: Both blood collection and utilization have declined, but the gap between collection and utilization is narrowing. As collections decline further and hospitals decrease transfusions and manage products more efficiently, the decline in surplus inventory may be a concern for disaster preparedness or other unexpected utilization needs.