Transfusion medicine
Blood bank testing
Automation


Topic Completed: 3 August 2020

Minor changes: 4 August 2020

Copyright: 2020, PathologyOutlines.com, Inc.

PubMed Search: Transfusion medicine automation[TIAB]

Raisa Balbuena-Merle, M.D., M.H.S.
Page views in 2020 to date: 89
Cite this page: Balbuena-Merle R. Automation. PathologyOutlines.com website. http://www.pathologyoutlines.com/topic/transfusionmedautomation.html. Accessed September 30th, 2020.
Definition / general
  • Method of blood processing and testing by an automated instrument
  • Semiautomated systems allow for partial manual labor with automated interpretation
Essential features
  • Blood bank automation is an alternate method to manual tube testing and blood processing in transfusion medicine
  • Promotes standardization of interpretation, increased transfusion safety, specimen batching and efficiency in turn around times
  • 3 methodologies currently exist for automated pretransfusion testing
  • Implementation requires appropriate equipment qualification (verification)
Terminology
  • Automated blood bank system
  • Automated pretransfusion compatibility testing
Application of automation in transfusion medicine
  • Blood component collection and processing
    • Separation into plasma, red blood cells and platelets components by apheresis
    • Leukoreduction to prevent transmission of CMV
  • RBC washing for IgA deficient patients (Transfusion 2015;55:2415)
  • ABO typing, antibody screening and compatibility testing in pretransfusion (immunohematology) testing
  • Product safety and detection of growth of microorganisms in platelets through culture: BacT / Alert (Transfus Med 2002;12:303)
  • Electronic crossmatch in patients with negative antibody screens
  • Supply of uncrossmatched blood through vending machines away from the blood bank (Transfusion 2018;58:372)
Automated and semiautomated methodologies
  • Solid phase red cell adherence assay (SRCA)
    • Serum added for antigen antibody reaction in microplates containing solid medium with reagent RBCs
    • Does not detect IgM
    • Capacity for platelet serology
  • Column agglutination test (CAT)
    • Microtubes with gel or microbead matrix containing antisera or antihuman globulin
    • Serum mixed with reagent RBC, agglutination of cells in the gel or microbead matrix constitutes test positivity
    • Open system
  • Erythrocyte magnetized technique (EMT)
    • Serum added to magnetized red blood cells inside a microplate that agglutinate after a magnetic force is applied
    • Eliminates need for centrifugation and washing steps
    • Does not detect IgM
  • These methodologies have superior sensitivity to conventional tube testing (Asian J Transfus Sci 2012;6:140)
  • Increased sensitivity is achieved with low ionic strength saline or bromelin methyl cellulose resulting in increased false positives
  • Does not allow for unrestricted modifications of testing like dithiothreitol (DTT) treatment and proteolytic enzymes

Pros and cons of automation
  • Increases blood bank testing capacity and throughput compared with manual technique
  • Avoids human errors and reduces staffing requirements (Asian J Transfus Sci 2015;9:S6)
  • Improves test reproducibility, traceability and patient identification with the use of specimen bar codes
  • Requires extensive validation which falls under the blood bank quality management structure and must meet FDA compliance [21 CFR Part 11] (FDA: Part 11, Electronic Records; Electronic Signatures - Scope and Application [Accessed 19 June 2020])
  • All equipment must be verified in compliance with safety and Clinical Laboratory Improvement Amendments quality standards
  • Guidelines for validation are provided by The International Society of Blood Transfusion (ISBT) (Vox Sang 2010;98:1)
  • Automated systems are more costly to acquire and maintain than the manual method and must be compatible with the institution's informatics system
  • Specific sample collection requirements and staff training are vital for adequate function
  • A backup system is necessary in anticipation of down time

Existing platforms of automated equipments
  • All platforms perform antibody screening, ABO group testing, crossmatching and direct antiglobulin test (DAT)
    • IH-100 by BIORAD (Switzerland)
      • CAT
      • Continuous reagents and sample loading
      • Additional features: extended phenotyping
    • Qwalys 3 by DIAGAST (France)
      • EMT
      • Continuous reagents and sample loading
      • Additional features: weak D testing and extended phenotyping
    • Galileo and NEO by IMMUCOR (USA)
      • SRCA
      • Continuous reagents and sample loading
      • Additional features: weak D, Rh phenotyping and platelet antibody screening and crossmatch
    • Wadiana and Erytra by Grifols (Singapore)
      • CAT
      • Batch testing for Wadiana and continuous loading or batch testing for Erytra
      • Additional features: enzyme assays, weak D (Erytra) and extended phenotyping
    • Autovue Innova and ORTHO VISION by Ortho Clinical Diagnostics (USA)
      • CAT
      • Continuous reagents and sample loading
      • Additional features: indirect antiglobulin test and RH / Kell phenotyping, serial dilutions for titers (ORTHO VISION)

Electronic crossmatching
  • Computer based crossmatch using recipient blood bank history to match with stored units
    • Software matches compatible stored units at the blood bank based on recipient historical blood bank data (ABO / Rh and antibody testing)
  • Substitutes for immediate spin compatibility testing (recipient's plasma / donor RBCs)
  • Benefits:
    • Accurate assignment of compatible units and verification of historical data
    • Faster release of units
    • Automated verification of units compatibility through barcodes
    • Promotes better use of storage by prioritizing units closer to expiration
  • Limitations:
    • Accuracy depends on extensive validation with the laboratory information system (LIS)
    • Not used for recipients with history of or newly formed clinically significant antibodies
      • Modified or additional restrictions are placed per institution, e.g. exclusion of recipients of ABO incompatible hematopoietic stem cells (Vox Sang 2013;104:350)
Board review style question #1
    As a blood bank director, you are appointed to oversee the implementation of a new automated system for pretransfusion testing. Which of the following is a requirement before implementation for all equipment used in collection, processing, testing or storage of blood components?

  1. Acceptable performance on external proficiency testing
  2. Calibration
  3. Equipment qualification
  4. Inspection from accreditation agencies (e.g. CAP)
Board review answer #1
C. Equipment qualification

Reference: Automation

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Board review style question #2
    Which of the following patients is the best candidate for a RBC transfusion using electronic crossmatching?

  1. 18 year old man with sickle cell disease and multiple RBC transfusions presenting with increased LDH, haptoglobin of < 10 mg/dL and hemoglobin of 5.4 g/dL
  2. 35 year old woman with history of SLE and history of warm autoantibody and mild thrombocytopenia of 100 K/cmm
  3. 45 year old woman with laboratories showing an MCV of 84.3 fL, hemoglobin of 7 g/dL, serum iron of 12 microg/dL (RR: 40 - 160 microg/dL), who had an positive antibody panel, showing a nonspecific antibody 5 years ago; current DAT and antibody screen is negative
  4. 87 year old man with anemia (Hgb 6.9 g/dL) and newly diagnosed multiple myeloma, no history of transfusions and a negative antibody screen
Board review answer #2
D. 87 year old man with anemia (Hgb 6.9 g/dL) and newly diagnosed multiple myeloma, no history of transfusions and a negative antibody screen

Reference: Automation

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