Evolution of PACS as a Model to Predict Adoption of Digital Pathology

1. Evolution of PACS as a Model to Predict Adoption of Digital Pathology Joe Biegel VP, Product Management McKesson Medical Imaging Group October 23, 2007

2. A Brief History of PACS Siemens/Philips start developing PACS concepts. EuroPACS starts annual meetings. 1984 US Army teleradiology project starts. 1983 Baumann and Gell follow up survey – 177 large PACS identified worldwide. 2000 US – Baltimore Veterans Hospital PACS. UK – Hammersmith and Conquest PACS projects. 1992 Original concepts: Dr. T. Iinuma, “Image processing in clinical medicine – considerations of a system”, Bull., Tokyo Women Med. 44, 152 (in Japanese). 1974 US National Cancer Institute funds UCLA group under Professor Bernie Huang. 1985 Multiple regional and national projects initiated. Worldwide mass adoption begins in earnest 2002 1970’s 1980’s 1990’s 2000’s Roger Baumann and Gunther Gell identify 23 large PACS worldwide with over 100 PACS projects. 1995 Dr. Samuel J. Dwyer III describes PACS ideas at a Seminar at the University of Iowa. Dr. Judith M. Prewitt introduces the term PACS. Cardiovascular radiologist Dr. Andre Duerinckx describes the far reaching future benefits of PACS for a hospital. 1981 Berlin BERKOM project started. 1986 NATO conference in France includes topic on Imaging Networks. SCAR celebrates 10th annual meeting. 1990 1st International Conference on the PACS, Newport Beach, California. 1982 PRIMIS created at VUB Brussels – to study applications of digital imaging. 1987

3. Replacement Mass Adoption Early Adopters Research Pioneers Departmental RIS/PACS Multi-Modality Viewing Apps Enterprise RIS/PACS Departmental PACS Single Modality Applications DICOM + HL7 ACR-NEMA 2.0 DICOM 3.0 IHE ACR-NEMA TCP/IP adoption Mainframe Computers Voice Recognition Optical Storage Jukeboxes Affordable UNIX workstations 9-track tapes NAS / SAN Hi-Res Displays Optical Storage Media Storage H/W $  HSM Systems PACS Market Evolution 1985 1990 2000 Market SolutionsOffered Standards Technology Enablers

4. Replacement Optical Imaging Mass Adoption Early Adopters Research Pioneers Cardiology PACS Market Replacement Mass Adoption Early Adopters Research Pioneers Radiology PACS Market Replacement Mass Adoption Early Adopters Research Pioneers The Evolution of Imaging IT Market Segments 1985 1990 2000 2010

5. Films with masters are delivered to Radiologist Clerks/Tech match up films to be read with patient’s master jacket Rad hangs films on view box Rad hangs previous for review Is there previous in master Rad enters MRN into RIS, finds patient, reviews results 1 No Rad dictates patient name, order, and accession number in dictation system, and dictates report Rad places signed daily with patient master jacket aside for pickup by clerical staff. Rad places films back into daily folder and signs bag Rad bar codes requisition into dictation system Rad bar codes requisition into dictation system 1 Rad opens unread worklist on PACS in dictate mode and opens first exam to be read Patient and order level information sent from PACS to RIS with no patient search required Dictation automatically initiated. Order information from the RIS automatically sent to dictation system. Rad clicks on clinical history icon to review patient’s reports and results from HIS/RIS 1 Relevant prior studies automatically display Next study is loaded. Dictation is initiated, and previous exam is marked dictated in PACS 1 Rad dictates report, and clicks next study Early Perceived Value Historical Radiologist Workflow Radiologist Workflow with RIS/PACS

6. Pathology progress, as compared to Radiology • The evolution of Digital Imaging in Radiology offers significant lessons for Pathology • Parallels with a later start, … but likely faster progress • Radiology in 1995 vs. Path in 2005 • Radiology today vs. Path in 2010 • Moore’s law helps • No need to repeat the same pitfalls Source: Bruce Beckwith, MD – 2005 DICOM International Conference – Budapest, Hungary

7. Radiology c. 1995 -vs- Pathology c. 2005

8. Radiology Now -vs- Pathology in 2010

9. Driving adoption is key • Automating the current workflow is only the first step • Both physical slide based workflow and digitized slide workflow will co-exist for a long time • Metadata (ie. patient demographic info, block/slide info) needs to be assigned to digitized WSI images • Manual data entry must be minimized whenever possible if WSI technology is to be incorporated into and ultimately replace existing physical slide based workflow • Economic drivers of digital pathology are evolving • Factors from outside the department will dominate • Standard of care, costs & reimbursement are the keys • Solution requirements will also evolve

10. Metadata Annotation Engine PACS 101010101 101010101 Histology Laboratory Physical Slides Slide Storage 101010101010101010 101010101010101010 Pathology WorkflowPresent & Future Cassettes/Blocks Gross Specimen Pathologist Orders: Recuts, Levels, IHC/Special Stains, Ancillary Studies WSI unique ID # for each WSI slide 1010101010101010101 H&E Data, IHC Data, Flags, Comments WSI or not WSI? 10110101010101010 Request WSI Images Via WSI unique ID# Request ROI Images 10110010101010101010101010101 10101010101 Block Data, Gross Description, Gross Images WSI Images as requested per case 10110010101010101010101 10101010101 10110010101010101 01010101010 101010101010110 Orders Patient/Case/Block Data, Prior Reports, Images (ROI) and WSI) Patient Block Slide Data attached to WSI Unique ID# APLIS Remote Operation 3rd Party Imaging Apparatus (TWAIN) 101010111011 10101010101010101010 Region of Interest (ROI) jpeg images (Direct Operation 3rd Party Imaging Apparatus) Load with WSI Unique Slide ID# Region of Interest (ROI) jpeg Images 101010110100101010101010101010101010 101010110100101010101010101010 10101010101010101010101010101010 Annotated Whole Slide Images (WSI) Analog Optical Image 3rd Party Whole Slide Imaging (WSI) Apparatus 10101101 Physical Slide 0101010101010101010010101010101010101010101101010101010101010101010101010101 Digitized Whole Slide Images (WSI) attached to WSI Unique ID# Source: Sourav Ray MD, et al: CAP, 2006

11. Future Pathology Workflow • The vision of automating the current workflow is a noble goal, but it is only the first step • The true value of Digital Pathology will have to be defined in terms of faster, improved Patient Care • Going Digital will change the practice of Pathology and will lead to a new, yet undefined workflows • Standards, IHE will help: necessary but insufficient to drive wide-scale adoption

12. DICOM in Pathology • Visible Light Supplement 15 • Included support for gross images, microscopic images, x,y.z position, lab accession numbers • Working Group 26 • Evolving to include whole slide imaging • Growing number of imaging products targeting pathology are DICOM compliant • US Veteran’s Administration: • Pathology imaging vendors must be DICOM compliant

13. Order Sample Sample Sample Block Block IHE-J in Pathology – Workflow/Data Structure Study Series Image Macro Image Slide Slide Slide Source: Tofukuji * Okuno – 2005 IHE –Japan Pathology WG

14. Departmental PACS diagnostic tools Collateral content 3D, Fusion, CAD Orthopaedic extensions Enterprise Worklist Departmental management & reporting tools EMR Integration Voice Recognition Structured Reporting: eg OB, ER discrepancy & critical results reporting Diagnostic Imaging Cockpit = ‘vision’ under pressure Diagnostic Imaging Cockpit

15. The Pathology “Cockpit” – current focus Worklist & Case History Gross / Low Res. Image Analysis Report Digital Slides A A B This is an example text bocks for the gross image shown above. This text is so small that it is unlikey that anyone can read it. Can you? I really doubt it. This is an example text bocks for the gross image shown above. This text is so small that it is unlikey that anyone can read it. Can you? I really doubt it. B Source: Aperio Technologies

16. Advanced diagnostic tools 3D, Fusion, CAD Muti-spectral imaging Test sub-routines (histology, etc.) Enterprise Worklist Departmental management & reporting tools EMR Integration Voice Recognition Structured Reporting Critical findings / ER ?? Departmental Productivity Reporting Pathology  Next stage Pathology Cockpit

17. Synergies with Diagnostic Imaging • Leverage image management infrastructure • Cost and expertise synergies will speed adoption • Routine access will likely create clinical use cases which will drive the adoption • The extent to which these use cases impact outcomes will impact market acceleration • Access needs vary • Pathologists want access to diagnostic image data • Radiologists have interest in access to summary data and no interest in WSI access

18. Value Points = Business Control Points • Modality = Data Acquisition • Storage = Physical Storage Devices (H/W) • Image Access Points = Clinical Application(s) • Workflow = Order  $ • Data = Data-mining • CAD – address the volume – may be more formative than in Radiology • Financial benefit needs to become more clear

19. Organic evolution is a slow, painful process with many side-tracks • Integration and interoperability with other systems is key to adoption • Isolated systems, IT-silos are short-lived, with limited clinical benefits • Don’t repeat the evolutionary sidetracks from the history of other clinical disciplines… • Use PACS as a starting point and build on it !!

20. Summary • Pathologists need PACS now • value is immediate • Pathologists should have PACS access now – the patient record needs to contain relevant imaging data • If you want to accelerate the adoption-curve of digital pathology: • ‘Hook’ your digital Pathology plans to your PACS • It is likely that early workflows will leverage other specialties, BUT these will inevitably be transient solutions with the “real” Digital Pathology workflow to follow • Pathology dept specific workflow solutions are needed and must have digital path imaging as part of the workflow now.

21. Questions?