Resource Utilization and Costs Associated with Serologic Testing Alyssa Ziman, M.D. Professor, Pathology & Laboratory Medicine Director, Clinical Laboratories for Ronald Reagan UCLA Medical Center Director, Transfusion Medicine 1
Disclosure • I have a relevant financial relationship with the products or services described, reviewed, evaluated, or compared in this presentation. • Ortho-Clinical Diagnostics, Inc. • Financial compensation • I have no relevant nonfinancial relationship to disclose. 2
Objectives Discuss • Costs associated with transfusion therapy • Pre-transfusion testing and associated costs • Serologic costs per work up and cost per patient as a factor of patient diagnoses • Potential opportunities to reduce costs associated with serologic testing 3
Wrapping our Arms Around the Cost of Transfusion Therapy • Transfusion (allogeneic) is one of the most common procedures in medical and surgical practice • RBC unit acquisition costs Stubbs. Transfusion 2014;54:259-262. 4
Wrapping our Arms Around the Cost of Transfusion Therapy • Operational costs of blood banks and transfusions services • Ordering pre-transfusion testing • Pre-transfusion sample collection and transport • Pre-transfusion testing • Cross-match procedures • Issuing of blood components • Transport of blood components to the bedside • Administration and monitoring of transfusion episodes • Costs associated with adverse events • Final documentation of transfusions in the medical record Stubbs. Transfusion 2014;54:259-262. 5
Wrapping our Arms Around the Cost of Transfusion Therapy • Additional costs: • Supply chain management • Information technology • Cost accounting and billing • Human resource management • Cleaning, waste management • Quality management • Accreditation and regulatory compliance, • Education and training, • Operations management Stubbs. Transfusion 2014;54:259-262. 6
Activity-based Costs of Transfusions • Activity-based Cost Analysis • Calculate the cost of complex processes to include direct and indirect costs associated with the entire process • Surgical Patients: total cost of transfusion in four hospitals in Europe and the United States. • Total cost of transfusion for a single RBC unit in a surgical patient: $726 - $1183 (data from the two US facilities). • US National Patient Costs (extrapolation) • 13.2 million RBC units were transfused in the United States in 2013 (National Blood Collection and Utilization Survey) • Mean value for activity-based cost of RBC transfusion: $954.50 • Annual cost of RBC transfusions: > $12.6 billion annually Shander. Transfusion 2010;50:753-65. 7 Chung. Transfusion. 2016 May 12 [Epub ahead of print]
Activity-based Costs of Transfusions • All transfused populations are not comparable to surgical patient populations used • Costs associated with the care of patients who have the wide array of disease processes that require transfusion support are much more variable 8
Activity-based Costs of Transfusions • Analysis of transfusion costs associated with individual medical and surgical diagnosis-related groups (DRGs) • DRG transfusion cost data from 1995 • 60 university hospital members of the University Health Systems Consortium • Findings • Blood transfusion costs accounted for approximately 1% of total hospital costs • Including both medical and surgical DRGs • Certain patient populations, blood costs accounted for higher proportions of total hospital costs. Jeffries. Transfusion 2001;41:522-9. 9
Activity-based Costs of Transfusions % Transfusion Median Mean Cumulative Patient Cost of Total Transfusion Transfusion Transfusion Costs Population Hospital Costs Costs Costs (Median x Discharges) (median %) $8,185,848 BMT Patients 7.1% $4444 $6183 (1842 hospital discharges ) Liver Transplant $6,018,624 5% $3888 $5527 Patients (1548 hospital discharges) Adult Leukemia $3,482,100 8.7% $2650 $4427 Patients (1314 hospital discharges) • Data could be used to focus on transfusion cost reductions targeted at specific DRGs or groups of DRGs Jeffries. Transfusion 2001;41:522-9. 10
Pre-Transfusion Testing 11
Activity-based Cost Analysis for Pre-Transfusion Testing • Pre-transfusion testing accounts for approximately 10% of the annual expenditure on RBC transfusions for US surgical patients • Approximately $95.45 per RBC transfusion • Value is representative of the cost of testing in other patient populations? • Significant differences in serologic testing? Shander. Transfusion 2010;50:753-65. 12
Purpose of Pre-transfusion Testing • Pre-transfusion compatibility testing encompasses much more than testing a patient’s sample in the laboratory. • Positive patient identification • Selection of suitable units • Identification of all special requirements • Review of all transfusion records and history and appropriate actions taken • Determination of ABO/Rh compatibility • Detection and identification of RBC allo- and autoantibodies Transfus Apher Sci. 2012 Jun;46(3):281-6. 13
Pre-Transfusion Testing AABB Standards for Blood Banks and Transfusion Services (29 th Edition) • 5.14.3 Unexpected Antibodies to Red Cell Antigens Methods of testing shall be those that demonstrate clinically significant antibodies. They shall include incubation at 37C preceding an antiglobulin test using reagent red cells that are not pooled. • 5.14.3.1 When clinically significant antibodies are detected, additional testing shall be performed. • 5.14.3.3 In patients with previously identified clinically significant antibodies, methods of testing shall be those that identify additional clinically significant antibodies. 14
Immunohematology Patient Testing Algorithm Review of pregnancy and transfusion history DAT vs. Provide RBC Unexpected Autocontrol units that are ABO/Rh Antibody phenotype Antibody Screen Identification Panel vs. negative for Select Cells (IAT) Process corresponding antibody; 2 cell screen: Phenotype serologic patient’s RBC for R 1 R 1 & R 2 R 2 cells crossmatch corresponding or antigen; additional 3 cell screen: phenotyping R 1 R 1 ,R 2 R 2 & rr cells (partial vs. full; genotype?) Candidate for immediate spin or computer (electronic) crossmatch 15
HI-STAR Study Hospital Investigation of Serologic Testing and Results 16
Study Goals • Describe all serologic testing processes performed on patients with antibody-positive screens to identify the antibodies present in their serum and provide compatible donor RBCs units • Subset these results for various patient subgroups based on diagnosis, transfusion history, and serologic test results • Understand the resource utilization and costs associated with these tests and for defined patient populations 17
Participating Sites • Brigham and Women’s Hospital Boston, MA • Ronald Reagan UCLA Medical Center Los Angeles, CA • University of Texas Southwestern Medical Center (UTSW) Dallas, TX • Virginia Commonwealth University Medical Center Richmond, VA 18
HI-STAR Methods • Retrospective data collection on approx. 1,500 Ab+ screens per site • Data collection period ranged from 11-19 months, depending on site 19
HI-STAR Methods • Inclusion Criteria • All antibody-positive patients with a focus on sub-populations of interest, e.g.: • Patients with hemoglobinopathies (e.g., SCD, thalassemia) • Patients with hematologic malignancies • Patients who have been multiply transfused • Patients with known alloantibodies • Positive Antibody Screen (IAT) • Exclusion Criteria • Positive antibody screen for patient when laboratory acting as an outside reference laboratory; concern over incomplete data set on patient 20
Data Abstraction • Each patient assigned a unique subject ID number • Each positive antibody screen was assigned a unique work ID number • Verification of data Demographic Data Transfusion Medicine Data • Up to 5 patient diagnoses to • Transfusion & RBC phenotyping hx indicate the reasons for transfusion • Hx of known allo- and autoantibodies • All serologic testing performed • Final results of the AbID process • Crossmatch testing performed • RBC units transfused 21
Patient Data Collected per Site BWH UCLA UTSW VCU All Sites Work-Ups (n) 1500 1576 1500 1501 6077 Patients (n) 847 961 1083 716 3608 Data verification (n) 95 99 95 120 409 Study Duration (months) 11 17 19 18 16 Number of patients who 49 58 37 76 220 died 22
Cost Analysis Data Collection • Site-specific unit cost data were collected for all serologic tests performed at each site • Unit costs were composed of the direct labor costs required to perform each test as well as direct material and equipment costs • Standard tool for all study sites • Listed test and actual hands-on tech time (incubation times not included) • Average hourly rate for testing employees (including benefits) • Included reagents and disposables 23
Cost Analysis • Site-specific costs for each test were averaged across all sites to obtain the unit costs used in the analysis • Within each diagnostic category, data were analyzed on a “per work - up” and a “per patient” basis • Cost per work up = sum of the costs for all serologic tests performed as a part of the work up • Cost per patient = sum of costs across all work ups performed on the patient during the study period 24
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