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

BACKGROUND: Effective and financially viable mitigation approaches are needed to reduce bacterial contamination of platelets in the US. Expected costs of large-volume delayed sampling (LVDS), which would be performed by a blood center prior to shipment to a hospital, were compared to those of pathogen reduction (PR), point-of-release testing (PORt), and secondary bacterial culture (SBC). METHODS: Using a Markov-based decision-tree model, the financial and clinical impact of implementing all variants of LVDS, PR, PORt, and SBC described in FDA guidance were evaluated from a hospital perspective. Hospitals were assumed to acquire leukoreduced apheresis platelets, with LVDS adding $30 per unit. Monte Carlo simulations were run to estimate the direct medical costs for platelet acquisition, testing, transfusion, and possible complications associated with each approach. Input parameters, including test sensitivity and specificity, were drawn from existing literature and costs (2018US$) were based on a hospital perspective. A one-way sensitivity analysis varied the assumed additional cost of LVDS. RESULTS: Under an approach of LVDS (7-day), the total cost per transfused unit is $735.78, which falls between estimates for SBC (7-day) and PORt. Assuming 20,000 transfusions each year, LVDS would cost $14.72 million annually. Per-unit LVDS costs would need to be less than $22.32 to be cheaper per transfusion than all other strategies, less than $32.02 to be cheaper than SBC (7-day), and less than $196.19 to be cheaper than PR (5-day). CONCLUSIONS: LVDS is an effective and cost-competitive approach, assuming additional costs to blood centers and associated charges to hospitals are modest.

Hepatitis E Virus Infection in Blood Donors and Risk to Patients in the United States and Canada.

Hepatitis E virus (HEV) is the most common cause of acute hepatitis worldwide including large water-borne outbreaks, zoonotic infections and transfusion transmissions. Several countries have initiated or are considering blood donor screening in response to high HEV-RNA donation prevalence leading to transfusion-transmission risk. Because HEV transmission is more common through food sources, the efficacy of blood donor screening alone may be limited. HEV-nucleic acids in 101 489 blood donations in the United States and Canada were studied. A risk-based decision-making framework was used to evaluate the quantitative risks and cost-benefit of HEV-blood donation screening in Canada comparing three scenarios: no screening, screening blood for all transfused patients or screening blood for only those at greatest risk. HEV-RNA prevalence in the United States was one per 16 908 (95% confidence interval [CI], 1:5786-1:81987), whereas Canadian HEV-RNA prevalence was one per 4615 (95% CI, 1:2579-1:9244). Although 4-fold greater, Canadian HEV-RNA prevalence was not significantly higher than in the United States. Viral loads ranged from 20 to 3080 international units per mL; all successfully typed infections were genotype 3. No HEV-RNA false-positive donations were identified for 100 percent specificity. Without donation screening, heart and lung transplant recipients had the greatest HEV-infection risk (1:366962) versus kidney transplant recipients with the lowest (1:2.8 million) at costs of $225 546 to $561 810 per quality-adjusted life-year (QALY) gained for partial or universal screening, respectively. Higher cost per QALY would be expected in the United States. Thus, HEV prevalence in North America is lower than in countries performing blood donation screening, and if implemented, is projected to be costly under any scenario.

Implementation of a patient blood management program in hematopoietic stem cell transplantation (Editorial, p. 2763).

BACKGROUND: Recipients of hematopoietic stem cell transplantation (HSCT) are among the highest consumers of allogeneic red blood cell (RBC) and platelet (PLT) components. The impact of patient blood management (PBM) efforts on HSCT recipients is poorly understood. STUDY DESIGN AND METHODS: This observational study assessed changes in blood product use and patient-centered outcomes before and after implementing a multidisciplinary PBM program for patients undergoing HSCT at a large academic medical center. The pre-PBM cohort was treated from January 1 through September 31, 2013; the post-PBM cohort was treated from January 1 through September 31, 2015. RESULTS: We identified 708 patients; 284 of 352 (80.7%) in the pre-PBM group and 225 of 356 (63.2%) in the post-PBM group received allogeneic RBCs (p < 0.001). Median (interquartile range [IQR]) RBC volumes were higher before PBM than after PBM (3 [2-4] units vs. 2 [1-4] units; p = 0.004). A total of 259 of 284 pre-PBM patients (91.2%) and 57 of 225 (25.3%) post-PBM patients received RBC transfusions when hemoglobin levels were more than 7 g/dL (p < 0.001). The median (IQR) PLT transfusion quantities was 3 (2-5) units for pre-PBM patients and 2 (1-4) units for post-PBM patients (p < 0.001). For patients with PLT counts of more than 10 × 109 /L, a total of 1219 PLT units (73.4%) were transfused before PBM and 691 units (48.8%) were transfused after PBM (p < 0.001). Estimated transfusion expenditures were reduced by $617,152 (18.3%). We noted no differences in clinical outcomes or transfusion-related adverse events. CONCLUSION: Patient blood management implementation for HSCT recipients was associated with marked reductions in allogeneic RBC and PLT transfusions and decreased transfusion-related costs with no detrimental impact on clinical outcomes.

A model-based cost-effectiveness analysis of Patient Blood Management.

BACKGROUND: Patient blood management (PBM) is a multidisciplinary concept focused on the management of anaemia, minimisation of iatrogenic blood loss and rational use of allogeneic blood products. The aims of this study were: (i) to analyse post-operative outcome in patients with liberal vs restrictive exposure to allogeneic blood products and (ii) to evaluate the cost-effectiveness of PBM in patients undergoing surgery. MATERIALS AND METHODS: A systematic literature review and meta-analysis were performed to compare post-operative complications in predominantly non-transfused patients (restrictive transfusion group) and patients who received one to three units of red blood cells (liberal transfusion group). Outcome measures included sepsis with/without pneumonia, acute renal failure, acute myocardial infarction and acute stroke. In a second step, a health economic model was developed to calculate cost-effectiveness of PBM (PBM-arm vs control-arm) for simulated cohorts of 10,000 cardiac and non-cardiac surgical patients based on the results of the meta-analysis and costs. RESULTS: Out of 478 search results, 22 studies were analysed in the meta-analysis. The pooled relative risk of any complication in the restrictive transfusion group was 0.43 for non-cardiac and 0.34 for cardiac surgical patients. In the simulation model, PBM was related to reduced complications (1,768 vs 1,245) and complication-related deaths (411 vs 304) compared to standard care. PBM-related costs of therapy exceeded costs of the control arm by € 150 per patient. However, total costs, including hospitalisation, were higher in the control-arm for both non-cardiac (€ 2,885.11) and cardiac surgery patients (€ 1,760.69). The incremental cost-effectiveness ratio including hospitalisation showed savings of € 30,458 (non-cardiac and cardiac surgery patients) for preventing one complication and € 128,023 (non-cardiac and cardiac surgery patients) for prevention of one complication-related death in the PBM-arm. DISCUSSION: Our results indicate that PBM may be associated with fewer adverse clinical outcomes compared to control management and may, thereby, be cost-effective.

Blood Transfusion During Total Ankle Arthroplasty Is Associated With Increased In-Hospital Complications and Costs.

INTRODUCTION: Total ankle arthroplasty (TAA) is an increasingly used, effective treatment for end-stage ankle arthritis. Although numerous studies have associated blood transfusion with complications following hip and knee arthroplasty, its effects following TAA are largely unknown. This study uses data from a large, nationally representative database to estimate the association between blood transfusion and inpatient complications and hospital costs following TAA. METHODS: Using the Nationwide Inpatient Sample (NIS) database from 2004 to 2014, 25 412 patients who underwent TAA were identified, with 286 (1.1%) receiving a blood transfusion. Univariate analysis assessed patient and hospital factors associated with blood transfusion following TAA. RESULTS: Patients requiring blood transfusion were more likely to be female, African American, Medicare recipients, and treated in nonteaching hospitals. Average length of stay for patients following transfusion was 3.0 days longer, while average inpatient cost was increased by approximately 50%. Patients who received blood transfusion were significantly more likely to suffer from congestive heart failure, peripheral vascular disease, hypothyroidism, coagulation disorder, or anemia. Acute renal failure was significantly more common among patients receiving blood transfusion ( P < .001). CONCLUSION: Blood transfusions following TAA are infrequent and are associated with multiple medical comorbidities, increased complications, longer hospital stays, and increased overall cost. LEVELS OF EVIDENCE: Level III: Retrospective, comparative study.

Reactive Blood Donor Notification; Their Responses And Perceptions: Experience From Southern Pakistan.

BACKGROUND: Donor notification of reactive status is important to prevent the spread of disease. Response of reactive donors to seek confirmation and treatment is a direct reflection of their knowledge and attitudes towards transfusion transmittable infections. METHODS: A cross sectional observational study was conducted from August 2014 to July 2015 at the blood bank of a tertiary care hospital, Karachi, Pakistan. Reactive donors' notification and responses were noted with reasons of failure. A cross-sectional analytical survey with non-probability purposive sampling was done on 350 potential consenting blood donors using a pre-tested questionnaire to assess their knowledge and attitude about disease awareness, transmission routes, financial implications and disease sensitization. RESULTS: Out of 16660 donations, 5.57% were rejected on positive screening tests. Repeat donors (69.5%) with primary to secondary qualifications constituted the bulk of reactive donors. Donor notification rate were 54.25% whereas 28.68% donors responded to blood bank in person. The survey showed limited awareness about transfusion transmitted infections. Respondents who were ignorant of disease spread through blood transfusion comprised of 48%. 96.6% donors did not know the financial impact of treatment and 69.7% were unable to afford it. Moreover, 94.9% donors were not protected against hepatitis B. Participants with secondary education had significantly less odds of being adequately knowledgeable (OR=0.372, 95% CI: 0.203-0.681, p-value <0.01) but more likely to have a positive attitude. CONCLUSIONS: There is need for structured pre-donation counselling to sensitize donors about transfusion related diseases in resource limited countries where treatment costs are high and out of reach for most donors..

Analysis of economic and social costs of adverse events associated with blood transfusions in Spain.

OBJECTIVE: To calculate, for the first time, the direct and social costs of transfusion-related adverse events in order to include them in the National Healthcare System's budget, calculation and studies. In Spain more than 1,500 patients yearly are diagnosed with such adverse events. METHOD: Blood transfusion-related adverse events recorded yearly in Spanish haemovigilance reports were studied retrospectively (2010-2015). The adverse events were coded according to the classification of Diagnosis-Related Groups. The direct healthcare costs were obtained from public information sources. The productivity loss (social cost) associated with adverse events was calculated using the human capital and hedonic salary methodologies. RESULTS: In 2015, 1,588 patients had adverse events that resulted in direct health care costs (4,568,914€) and social costs due to hospitalization (200,724€). Three adverse reactions resulted in patient death (at a social cost of 1,364,805€). In total, the cost of blood transfusion-related adverse events was 6,134,443€ in Spain. For the period 2010-2015: the trends show a reduction in the total amount of transfusions (2 vs. 1.91M€; -4.4%). The number of adverse events increased (822 vs. 1,588; +93%), as well as their related direct healthcare cost (3.22 vs. 4.57M€; +42%) and the social cost of hospitalization (110 vs 200M€; +83%). Mortality costs decreased (2.65 vs. 1.36M€; -48%). DISCUSSION: This is the first time that the costs of post-transfusion adverse events have been calculated in Spain. These new figures and trends should be taken into consideration in any cost-effectiveness study or trial of new surgical techniques or sanitary policies that influence blood transfusion activities.

Direct costs of transfusion reactions - an expert judgement approach.

BACKGROUND AND OBJECTIVES: Despite increasingly meticulous haemovigilance reporting throughout the world, a systematic assessment of the cost of transfusion reactions is still lacking. This is partly caused by the fact that such an assessment requires a subjective expert assessment of the additional costs linked to the adverse reaction. Data on the cost of transfusion reactions could support decision-making regarding blood transfusion safety measures. MATERIALS AND METHODS: Thirteen experts from nine hospitals were asked to estimate the additional care required following various types of transfusion reactions. Additional care was quantified as the proportion of reactions requiring care, and the amount of care required (e.g. hospitalization days, additional physician's time). Experts were also asked to provide, per type of transfusion reaction, an estimate of the proportion of transfusion reactions preventable. Structured quantitative expert elicitation methods were applied to obtain and combine expert estimates. RESULTS: The estimated annual in-hospital cost of transfusion reactions in the Netherlands is €933 356 per year (€1.52 per transfusion). Two-thirds (64%) of these are incurred by non-serious transfusion reactions. Circulatory overload, TRALI and anaphylaxis clearly dominate the costs of serious adverse transfusion reactions (66% in total); non-haemolytic transfusion reactions incur 46% of the cost of non-serious transfusion reactions. Additional safety measures targeting circulatory overload and new antibody formation potentially offer the highest cost reduction. CONCLUSION: In-hospital costs of transfusion reactions are substantial but contribute to less than 1% of the total cost of transfusion in the Netherlands. A considerable part of these costs (24%) might be preventable.

Feeling the burn: the significant burden of febrile nonhemolytic transfusion reactions.

BACKGROUND: Febrile nonhemolytic transfusion reactions (FNHTRs) are characterized by a post-transfusion temperature rise (of ≥ 1°C, to ≥ 38°C) or chills/rigors unrelated to the underlying condition. FNHTRs are provoked by inflammatory cytokines in the product or by host antileukocyte antibodies against residual donor leukocytes. FNHTRs are among the most commonly reported transfusion disturbances and are generally deemed nonserious events. However, their impact on patients and hospitals may be underestimated. STUDY DESIGN AND METHODS: A search through two hemovigilance databases identified all known possible-to-definite FNHTRs over 3 years (2013-2015) at four academic hospitals using prestorage leukoreduced components. FNHTRs were assessed for frequency by product (red blood cells [RBCs], platelets [PLTs], intravenous immunoglobulin), diagnostics (bedside, chest imaging, serology, microbiology), and management (medications, disposition change). The definition of FNHTR was derived from Canada's Transfusion-Transmitted Injuries Surveillance System. RESULTS: For 437 FNHTRs, the overall per-product rate across all sites was 0.24%, or 0.17% with RBCs alone and 0.25% with PLTs alone. One-third of patients had significant fevers (≥ 39.0°C or a rise by ≥ 2.0°C). Approximately one-quarter underwent chest imaging within 48 hours, and 79% had blood cultures. A hospital admission directly attributable to the FNHTR, to exclude other causes of fever, occurred in 15% of FNHTR outpatients. CONCLUSION: An analysis of FNHTRs reveals a substantial burden of postreaction clinical activity in addition to the disturbance itself. Efforts to avoid this adverse event may save resources, reduce patient distress, and encourage compliance with more restrictive transfusion strategies.