Resource Utilization and Costs Associated with Serologic Testing - - PowerPoint PPT Presentation

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Resource Utilization and Costs Associated with Serologic Testing - - PowerPoint PPT Presentation

Nov 14, 2022 26 likes •530 views

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

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Resource Utilization and Costs Associated with Serologic Testing

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Alyssa Ziman, M.D.

Professor, Pathology & Laboratory Medicine Director, Clinical Laboratories for Ronald Reagan UCLA Medical Center Director, Transfusion Medicine

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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

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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

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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

4

  • Stubbs. Transfusion 2014;54:259-262.
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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

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  • Stubbs. Transfusion 2014;54:259-262.
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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

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  • Stubbs. Transfusion 2014;54:259-262.
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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

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  • Shander. Transfusion 2010;50:753-65.
  • Chung. Transfusion. 2016 May 12 [Epub ahead of print]
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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

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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.

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  • Jeffries. Transfusion 2001;41:522-9.
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Activity-based Costs of Transfusions

  • Data could be used to focus on transfusion cost

reductions targeted at specific DRGs or groups of DRGs

Patient Population % Transfusion Cost of Total Hospital Costs (median %) Median Transfusion Costs Mean Transfusion Costs Cumulative Transfusion Costs

(Median x Discharges)

BMT Patients 7.1% $4444 $6183 $8,185,848

(1842 hospital discharges)

Liver Transplant Patients 5% $3888 $5527 $6,018,624

(1548 hospital discharges)

Adult Leukemia Patients 8.7% $2650 $4427 $3,482,100

(1314 hospital discharges)

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  • Jeffries. Transfusion 2001;41:522-9.
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SLIDE 11

Pre-Transfusion Testing

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Activity-based Cost Analysis for Pre-Transfusion Testing

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  • Pre-transfusion testing accounts for approximately 10%
  • f 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.
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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

13

Transfus Apher Sci. 2012 Jun;46(3):281-6.

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Pre-Transfusion Testing

AABB Standards for Blood Banks and Transfusion Services (29th 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.

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Immunohematology Patient Testing Algorithm

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ABO/Rh Antibody Screen (IAT)

2 cell screen: R1R1 & R2R2 cells

  • r

3 cell screen: R1R1,R2R2 & rr cells

Unexpected Antibody Identification Process

Review of pregnancy and transfusion history DAT vs. Autocontrol

Provide RBC units that are phenotype negative for corresponding antibody; serologic crossmatch

Panel vs. Select Cells Phenotype patient’s RBC for corresponding antigen; additional phenotyping (partial vs. full; genotype?)

Candidate for immediate spin or computer (electronic) crossmatch

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HI-STAR Study

Hospital Investigation of Serologic Testing and Results

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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

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Participating Sites

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  • 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

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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

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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

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Data Abstraction

  • Each patient assigned a unique subject ID number
  • Each positive antibody screen was assigned a unique

work ID number

  • Verification of data

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Demographic Data

  • Up to 5 patient diagnoses to

indicate the reasons for transfusion

Transfusion Medicine Data

  • Transfusion & RBC phenotyping hx
  • Hx of known allo- and autoantibodies
  • All serologic testing performed
  • Final results of the AbID process
  • Crossmatch testing performed
  • RBC units transfused
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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 died 49 58 37 76 220

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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

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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

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Results

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Serologic Testing Costs

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Diagnoses and Testing/Transfusion History

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Workups per Patient by Diagnosis

  • 0.50

1.00 1.50 2.00 2.50 3.00 3.50 4.00 28

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Calculating Average Cost per Workup

  • For each diagnostic or non-diagnostic category studied,

determine:

  • Average number of times that each serologic test was

performed per workup, multiplied by

  • Average cost of that serologic test

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Cost per Serologic Work Up

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Mean Cost per Patient Over Duration of Study

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Mean Cost per Patient Over Duration of Study

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Mean Cost per Patient Over Duration of Study

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Mean Cost per Patient Over Duration of Study

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Average Cost per Workup by Diagnosis

Note: Based on 6,077 Ab+ workups.

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HI-STAR Study Summary

  • Wide variation in cost per work up and cost per patient
  • Function of diagnosis
  • Function of historical variables such as previous transfusions

and known allo- and autoantibodies

  • Mean follow-up period of over 1 year
  • Long-term serologic testing costs per patient are conservative

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HI-STAR Study Summary

  • Testing costs varied across sites
  • Different testing methods employed by the sites
  • Varying levels of automation
  • Different wage rates paid to technologists in different geographic

areas

  • Molecular genotyping not included

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SLIDE 38

HI-STAR Study Summary

  • Testing costs varied across sites
  • Different testing methods employed by the sites
  • Varying levels of automation
  • Different wage rates paid to technologists in different geographic

areas

  • Molecular genotyping not included

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Opportunities to Reduce Costs associated with Serologic Testing

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Change Testing Algoritms

  • Antibody identification work-ups
  • Often require manual processes
  • Labor-intensive and
  • Time-consuming
  • Faced with increasing costs, increased work-load, and a

diminishing workforce

  • Decrease repetitive, noncontributory

ABI investigations for frequently transfused alloimmunized patients?

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Elution

(1st positive or significant change in reactivity strength + recent transfusion)

UCLA Testing Algorithm

Positive Antibody Screen Antibody Identification Direct Antiglobulin Test (DAT) Panreactive c/w WAA IgG C3 Saline IgG r/o Underlying Alloantibodies Adsorption

Autoadsorption – no recent hx of transfusion; sufficient specimen Alloadsorption – transfusion w/in past 3 months; insufficient specimen (require full phenotype for cell selection)

Panreactive = Reactions

Phenotype (Rh/Kell)

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Increase the interval between Antibody Identification Work-up?

  • Current algorithm
  • All patients must have a sample drawn for pre-transfusion testing within

72h of a scheduled transfusion

  • For patients with a positive antibody screen, ABI is performed every 72h
  • Proposal
  • Increase the interval between ABIs in previously alloimmunized patients

from every 72h to 14 days

  • By decreasing the number of ABIs performed →
  • Reduce costs
  • Increase productivity by allowing technologists to perform other

tasks

  • Decrease TAT for issuing products in alloimmunized patients
  • Improve patient satisfaction.

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  • Goss. Transfusion. 2016 Feb;56(2):334-8.
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Methods

  • Retrospective data collection of all antibody identification

work-ups performed over a 2-year period

  • Inclusion criteria
  • Antibody identification with a clinically significant antibody that

would impact blood component selection

  • Exclusion criteria
  • Only clinically insignificant antibodies that would not impact the

blood component chosen for the patient or transfusion management

  • Excluded antibodies/patterns of reactivity: warm or cold

autoantibodies; nonspecific reactivity, passively acquired anti-D; and alloantibodies against M (IgM), N (IgM), Lea, Leb, Lua, Lub, P(IgM), Bg, and Knops system

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Results

  • 8948 antibody investigations, 2792 patients over 2-year period
  • 618 patients had an ABI with newly identified alloantibody within 1-14 days of a

previous ABI (when that antibody had been ruled out).

  • Application of exclusion criteria: 30 patients with 33 antibodies
  • Application of antibody diagnostic categories: 13 newly formed clinically

significant alloantibodies

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Results

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Cost-Reduction Analysis

  • Proposal to increase ABI interval from 72h to 14 days
  • Reduce the number of ABIs performed annually by 250.
  • Cost-reduction analysis based on HI-STAR
  • Mean ABI cost = $180 per antibody identification
  • Savings: minimum $45,000 per year

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Conclusions

  • Increasing AbID work-up interval to 14 days could result

in delayed identification of new alloantibody specificity in 13 patients.

  • 0.5% of all AbIDs performed
  • 0.47% of all alloimmunized patients that have a type and screen
  • Alternative approach: perform AbID only with a change

in the antibody screen results for immunized patients

  • 5/13 samples were associated with no change in the screen

results  5 new antibodies would be missed

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Conclusions

  • Caveat: Full serologic crossmatch allows for detection
  • f a new clinically significant antibody
  • Conclusion: Despite the potential cost savings, retained

72h policy for repeating the AbID given the small but potentially significant risk of failing to detect the development of a new alloantibody in previously immunized patients.

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Application of Molecular Techniques

  • Potential for minimizing RBC alloimmunization up front
  • Decreasing the overall costs of transfusion care by decreasing

the number of complex serologic transfusion patients

  • Alternative method of identifying RBC units for safe

transfusions in alloimmunized patients

  • Matching donors and recipient via extended RBC genotypes
  • Minimizing/eliminating repeat and expensive serologic

evaluations

  • Result in cost savings?

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Klapper Transfusion 2010;50:536-46.

  • Wagner. Transfusion 2008; 48: 1169-73.
  • Jungbauer. Vox Sang 2012; 102: 234-42.
  • Gassner. Transfus Med Rev 2013; 27: 2-9.

Latini Blood Transfus 2014; 12 (Suppl 1): s256-63.

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Summary

  • Costs associated with transfusion therapy can be

substantial and are not merely associated with blood product acquisition and transfusion administration

  • Pre-transfusion testing costs can also be substantial

and are associated with patient diagnoses and transfusion history

  • Potential opportunities to reduce costs associated with

serologic testing , such as changes in testing algorithms

  • r adoption of new technology, must be considered.

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Document Number PR-02276