Evaluation of automation for a multisite TMS

1
Evaluation of Automation for a Multi-Site
Transfusion Medicine Service Lester C. , Boychuk
D., MacDonald A.,Warkentin T.E., Hamilton
Regional Laboratory Medicine Program (HRLMP),
Hamilton Health Sciences and St. Josephs
Healthcare Hamilton, ON

• BACKGROUND
• The Hamilton Regional Laboratory Medicine Program
  (HRLMP) is a jointly owned and operated clinical
  service program of Hamilton Health Sciences (HHS)
  and St. Joseph Healthcare.
• HRLMP operates four Transfusion Medicine (TM)
  laboratories located in each of the acute care
  sites across the two institutions under a single
  management structure.
• The implementation of automation has long been
  identified as an enabler to the consolidation of
  our Transfusion Medicine services.
• The Ortho ID-MTS Gel test has been employed as
  our routine antibody detection methodology at all
  4 Transfusion Medicine testing sites since 1999.
• On November 18, 2005, the Ortho PROVUE system
  was installed for evaluation

• On average turnaround time for patient testing
  increased 36 when using PROVUE
• Red cell unit group confirmation increased 9-fold
  compared to manual method

• RESULTS
• Sensitivity Evaluation
• PROVUE testing identified 3 samples where mixed
  field had been missed in the ABO/Rh testing by
  our standard tube method
• 100 of the 449 samples were reactive by one or
  both techniques
• Differences of 1 or greater were considered
  significant and included in the chart below

Table 2. Timed study MTS Manual vs. PROVUE

• Project Goals
• Evaluate the sensitivity
• Evaluate the specificity
• Assess turnaround time
• Assess the PROVUE for ease of use

• Assess the PROVUE for ease of use
• Easy to use
• Allows the operator to load and walk away to
  perform other duties  
• Instrument intervention only required to
  troubleshoot error codes
• (most often errors resulting from cassette
  failure or inability of the instrument to read
  barcode)
• Minimal maintenance required
• Additional Requirements identified during
  evaluation of the PROVUE
• Need for interface with computer system to
  facilitate reporting of results
• Need for tube cap removal process

Figure 1. Ortho PROVUE
Table 1. Summary of differences of antibody (Ab)
screen and Direct Antiglobulin tests (DAT)
results PROVUE vs. MTS manual or tube

• METHOD
• A variety of samples were tested during the
  3-month evaluation period from December 2005 to
  February 2006
• 449 fresh and frozen patient samples were tested
• Parallel antibody screening was performed via
  manual gel testing vs. PROVUE automated gel
  testing
• Approximately 80 ABO/Rh blood group confirmations
  were tested in parallel using manual tube method
  and PROVUE
• Various test profiles utilized
• Timed studies to determine possible impacts on
  workflow

• Specificity Evaluation
• 449 Patient samples were tested for the presence
  of antibodies using both a manual MTS gel
  technique and the PROVUE
• Unexpected reactivity was demonstrated in 5
  samples when tested with PROVUE though repeat
  testing of these samples resulted in negative
  antibody screens. The age and quality of these
  samples may have contributed to these findings.
• A selection of known antibodies gave comparable
  reactivity by both techniques

• CONCLUSION
• Sensitivity of the PROVUE allows for the
  detection of weak reactivity missed by manual
  methodology
• Although turnaround time was markedly increased
  automation provided the user the ability to
  perform other duties while testing was in
  progress.
• The PROVUE barcode reading capability and three
  onboard cameras provide continuous sample and
  reagent tracking, ensuring positive sample
  identification and reagents appropriate to the
  tests ordered.
• The introduction of automation would enable our
  TM service to consolidate the testing of
  non-urgent samples to a centralized location.

• Antibodies tested included the following
• 19 Rhesus antibodies 8 Bg antibodies 1 anti I
• 10 Kidd antibodies 7 Kell antibodies 1 anti H
• 9 Passive anti D 8 Unidentified 3 non
  specific
• 1 anti M 1 anti P1 2 HTLA antibodies

• REFERENCES
• Ortho PROVUE Users Guide Version 2 2004-2005
  Ortho Clinical Diagnostics

ACKNOWLEDGEMENTS Special thanks to
Ortho-Clinical Diagnostics Ltd for their support
in arranging for the delivery and installation of
the Ortho PROVUE and for the technical support
provided during this evaluation period.