The Case for Integrated Digital Workflow for Next Generation Pathology Practice

1
The Case for Integrated Digital Workflow for Next
Generation Pathology Practice

• Michael Becich, MD, Ph.D UPMC
• Ann Cecil, Trestle Holdings, Inc.
• Anthony Taddey, Trestle Holdings, Inc.
• Maurizio Vecchione, CEO Trestle Holdings, Inc.
• Jack Zeinah, MD Trestle Holdings, Inc.

2
Digital Imaging Provides Compelling Advantages

• Communication Collaboration
• Improved Case Management
• Quantitative Scoring
• Imaging Enhanced Reporting
• Improved Compliance
• Improved Quality Control

• Improved Patient Care Reduced Cost

3
Adoption in the marketplace is at an inflection
point

• Clinical Reference Laboratories
• Hospitals Medical Schools
• Bio-pharmaceutical Drug Developer
• Government
• Armed Forces
• NIH
• NCI
• FDA

4
Digital Imaging is Nearing FDA Clearance

• Clinical validation study shows
• 4.3 discrepancy with traditional techniques
  (glass)
• No meaningful deviation or bias introduced by
  digital imaging in diagnoses
• 40x, non interpolated focus and lockable data
  base are key ingredients to assure image
  integrity
• FDA has expressed opinion that Digital Imaging
  for Pathology requires Class II 510(k) clearance
• Clinical validation study pave the way to
  clearance

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UPMC/Trestle Clinical Validation Study
4.3 discrepancy Compared with 1.4 to 5.7.
discrepancy rates based upon routine second
opinion
202 Cases 1800 Slides 606 Diagnoses

• Level A Minimal disagreements, undetected errors
  in nomenclature, or other such lapses that do not
  change the diagnosis or affect care.
• Level B Minor disagreements, such as use of
  alternate nomenclature, or lack of
  straightforwardness in diagnosis.
• Level C Defect in diagnosis with minimal effect
  on patient care, e.g., histopathologic
  differences that do not influence prognostic
  values, or rendering the final diagnosis
  ambiguous, or failure to review relevant prior
  accessions.
• Level D Major discrepancies in diagnosis that
  would affect the treatment of a patient and that,
  if confirmed, would require the issuance of a
  corrected report.

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Insertion of Digital Imaging in Clinical Practice
is Challenging

• Case management
• How do we know that all relevant files are
  associated with a case?
• Scalability
• How do we deal with all the files that digital
  imaging generates?
• Control Mechanisms
• How do we guarantee imaging data integrity,
  compliance?
• Integration with LIS
• How do we avoid double entry?

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Integrated Workflow Software Provides Solutions

• Improved Case Management
• Automated association of files to case
• Seamless integration with LIS and case data
• Automated audit and access controls
• Integrated editing, viewing, comparison,
  annotation and conferencing features
• Imaging enhanced reporting
• Interface to quantitative scoring

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Case Study Shows Compelling Efficiency Gains

• Case study in medium size hospital laboratory
• In addition, the analysis showed that the
  department could perform existing work with 0.5
  fewer pathologists and 2 fewer technicians which
  is equivalent to a savings of 180,000 on a
  non-fully loaded basis

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The Future Plug Play Device Open Architecture

• Common workflow platform
• Open integration with LIS
• Open integration with imaging instruments
• New revenue opportunities
• CPT codes provide new revenue opportunities as
  they are interpreted to include digital imaging
• Quantitative Scoring (e.g. 83950)1
• Tele-pathology Consultations (e.g. 88321, 88325)2
• Imaging enhanced reporting provides additional
  revenue opportunities
• 1 HER-2/neu Status Comparison of Quantitative
  Immunohistochemistry by Automated Cellular
  Imaging and Fluorescence In Situ Hybridization.
  Pathology Case Reviews. 7(2)75-80, March/April
  2002.Shukla, Deepti MD Veeramachaneni, Ravindra
  MD Abreo, Fleurette MD Nordberg, Mary Lowery
  PhD
• 2 Current Procedural Terminology, American
  Medical Association

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For More Information

• Maurizio Vecchione
• CEO
• Tel. [phone]
• Email mv_at_trestlecorp.com