1. Implementing a Digital Pathology System for Primary Diagnosis: The nuts & bolts Liron Pantanowitz MD Professor of Pathology & Biomedical Informatics Director of Pathology Informatics UPMC, Pittsburgh, USA

2. Notice of Faculty Disclosure
In accordance with ACCME guidelines, any individual in a position to influence and/or control the content of this ASCP CME activity has disclosed all relevant financial relationships within the past 12 months with commercial interests that provide products and/or services related to the content of this CME activity.
The individual below has disclosed the following financial relationship(s) with commercial interest(s):
Liron Pantanowitz, MD
Omnyx
Consultant fee
Consultant

3. Objectives
Review lessons learned from labs that have already committed to going fully digital
Highlight parameters to consider when implementing a full digital pathology system
Offer recommendations for labs contemplating such a digital transition

4. Introduction Going entirely digital is defined as:
Digitizing all glass slides
With whole slide imaging
Prospective scanning
For primary diagnosis
Very few labs in the USA have gone entirely digital for primary diagnosis
Only rare pathology labs in Europe have started their digital conversion

5. University Medical Center Utrecht
J Pathol Inform 2013; 4:15
University Medical Center Utrecht
Digital slides routinely scanned at ×20 magnification
Results on average with file sizes of 350 MB
Tiered storage system (top tier is a fast disk based solution and lower tier a tape archive)

6. Kalmar County Hospital & neighboring Linköping University Hospital
J Pathol Inform 2014; 5:14
Kalmar County Hospital & neighboring Linköping University Hospital
150 cases/week outsourced to a private clinic for primary review
Slides scanned mostly at ×20 (0.49 microns/pixel)
For data storage average size of 0.4 GB per slide
Keep 6 months of digital slides, and older slides are automatically deleted

7. European Experience: Some Lessons
Full implementation occurred after positive internal validation
Glass slides scanned were also physically delivered to pathologists
Conventional & digital workflow is maintained simultaneously
Measures to reduce scan failure rate (e.g. smaller tissue on slides, baking slides prior to scans, cleaning slides)
Barcoding to automatically connect scanned slides to cases in LIS
Bulk scanning occurred overnight; daytime flexibility (e.g. rush cases)
Measures to avoid scanner downtime (e.g. use UPS, use LED light sources to limit calibrations, reboot PC daily to avoid memory issues)

8. Pittsburgh Experience
UPMC started their (preparation for) conversion to digital pathology many years ago
Implementation of a digital pathology platform for primary diagnosis began around 1 year ago

9. Value Proposition

10. Return on Investment

11. Planning Stage Engagement of key stakeholders Budget considerations
Pathologists (identify champions, involve senior leaders)
Non-pathologists (IT division, lab managers, admin folks)
Budget considerations
Technology (scanners, workstations, storage, facilities)
Staff (imaging technicians, IT analysts, admin support)
Flexibility
Successive consolidation of services
Factor in changes in technology
Regulatory environment (FDA)

12. Operations Facility renovations Workflow impact Validation & Training
Accommodate scanning (core lab, space, device weight/size, lean location near slide production, noise, maintenance, slide storage)
Sign out areas (offices, sign out area/rooms, retaining microscopes, lighting, mounted monitors, desk modifications)
Workflow impact
Pre-imaging factors (barcoding, tissue placement, slide preparation, avoiding pen marks and sticky labels)
Hybrid workflows (digital & glass slides, case selection for scanning)
Downtime plan (scan failure, monitor interfaces, notifications)
Validation & Training
Follow CAP guidelines
Training pathologists
Data capture (feedback, studies)

13. Core Histology Lab

14. Digital Workflow
Note: Adding a WSI scanner to workflow causes several changes upstream & downstream

16. Office Workstation

18. Training Pathologists

19. Information Technology
Vendor solution
Suitable hardware (scanners, server) & Software
Development (test) & Production (live) systems
Separate Clinical & Education/Research environments
Data storage
Scan magnification (20x &/or 40x)
Local &/or central data repository
Retention policy & Hot/Cold storage
Boosting network connectivity (1 GB)
LIS integration
Back-end interface (web service/HL7 interface)
Automatic slide/case matching & access to metadata
Front-end solutions (single sign-on to PACS, EMR, etc.)
Workstation deployment
Histology lab, offices & sign out rooms
PC requirements (e.g. 64-bit OS)
Web-enabled solution

20. Example of Storage Projections
Stages
Year 1
Year 2
Year 3
Year 4
Year 5
Hot (TB)
21.42
86.76
180.2
266.37
305.73
Cold (TB)
0.00
108.18
266.78
446.39
572.11
Back up (TB)
180.02
Total (TB)
42.84
281.70
626.82
979.13
Courtesy of Gonzalo Romero Lauro
Total estimated storage needs = TB

21. Clinical Use Cases Incremental workload increase
Stepwise subspecialty rollout plan
E.g. Surgical pathology (first small biopsies, fewer parts)
Autopsy service, including neuropathology (slower TAT)
Exceptions (cytology, hematopathology, cases with bugs)
Digital consultation (internal/external)
IHC core lab (centralization of staining)
Image analysis (e.g. breast markers)
Others (QA, archiving, projects, etc.)

22. Rate of Adoption Accelerated Rollout Incremental Adoption Advantages
Disadvantages
Full Span
Higher Upfront Cost
Lower Upfront Cost
Limited Span
Focused Support
Immature Adoption
Mature Adoption
Extended Support
Faster Feedback
Limited Use Cases
Lower Refresh Cost
Slow Feedback
Less Time
Impacts Operations
Clinical Validation
Takes Longer

23. Change Management Project activities not to be overlooked:
Communication (e.g. memos, grand rounds)
Ongoing training (especially for pathologists)
Lots of meetings (histology lab, IT, vendor)
Keep senior leadership in the loop (lab visits)
Engage pathologists (validations, studies)
Empower users (let them help solve problems)
Monitor for any diagnostic discrepancies
Expect "unexpected" consequences of change
Other minor issues (critics, outside visitors)

24. Change Curve Commitment Change Skeptics Denial Confusion Acceptance
Positive
Commitment
Change
Skeptics
Denial
Confusion
Acceptance
Optimism
Some ideas
Impact
Resistance
Anger
Negative
Status Quo Disruption Exploration Rebuilding
Stages (time)

25. Take Home Points
Key internal factors: leadership support, IT infrastructure
Important external factors: changes in technology
Consider incremental rollout over accelerated adoption
Early wins provides good proof of concept & champions
Faculty engagement is key (create a digital culture for buy-in)
Benefits of adopting digital pathology early on include:
Possible ROI (e.g. consolidation of services)
Some efficiencies (e.g. timely IHC review, consultation)
Digital platform to build on (e.g. image analysis, database)