Lessons learned in the use of digital imaging at Memorial Sloan Kettering Cancer Center

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1 Lessons learned in the use of digital imaging at Memorial Sloan Kettering Cancer Center Executive War College May 3, 2018 Victor E. Reuter, M.D. Vice-Chair, Department of Pathology Medical Director, Warren Alpert Center for Digital Imaging and Computational Pathology

2 Background Memorial Sloan Kettering Cancer Center 473 Inpatient Beds

3 Background Large Anatomic Pathology Laboratory Pathologists: ~60 Median over 3 years (2015 to 2017) Case Accessions: 161,730 In-house Surgical Cases: 49,623 Consult Cases: 29,644 Total accessioned cases Surgical Consult

4 Background Total Slides Subspecialty Distribution

5 MSK Pathology Inventory In-house storage: Slide Library and Basement 2012 present Approx. 2.8M slides Offsite storage: 3 different locations older Estimate >25M slides Required to keep slides/blocks for 20 years, per NYS regulations Offsite storage expense - approx. $400K/year

6 ANATOMIC PATHOLOGY WORKFLOW Specimen accessioning Specimen prosecting Tissue fixation Tissue processing Electronic Medical Record Laboratory Information system Billing Case sign-out Ancillary Studies Case assembly and distribution Slide labeling Tissue embedding Tissue cutting and generation of unstained slides Deparaffinization And H&E staining Slide coverslipping

7 ANATOMIC PATHOLOGY WORKFLOW Specimen accessioning Specimen prosecting Tissue fixation Tissue processing Bar code Electronic Medical Record Laboratory Information system Billing Case sign-out WSI Ancillary Studies WSI Case assembly and distribution WSI Slide labeling Tissue embedding Tissue cutting and generation of unstained slides Deparaffinization And H&E staining Slide coverslipping

8 DIGITAL PATHOLOGY Potential applications of WSI at MSK circa 2008 comprehensive digital pathology sign-out remote pathology (BR, C, BAIC, 53 rd St) second opinion consultations frozen section consultation signal quantification archiving and retrieval education QA Implementation because we can versus Implementation because we should Needs assessment in an environment where there is resistance to change and competing priorities Establish value added to stakeholders

9 Despite barriers to early adoption Early Utilization of Whole Slide Imaging by niche application at MSK Some scanning of clinical cases (2008, no bar codes) Tumor Board: 2009-present Digital Slide Education Module: 2009-present Frozen section equivalence study: Pathol Visions 2009 Tumor reporting metrics (Rodriguez-Urrejo P et al, Hum Pathol 2011;42:68 Signal quantification: Schaffel R et al. Ann Oncol 2010;21:133 Tang L et al. AJSP 2012;68:1761 Visiting professor slide sessions with residents: 2011-present drew very little traction with hospital administration

10 with time. Transformative change in the local environment Improvement in hardware/software technology Increased in the number of vendors Commitment from senior leadership** Increased investment in technology Increased focus on pathology informatics Integration with LIS Regulatory oversight (FDA)

11 Opportunity for Improvement Digital Pathology at MSK First scanner purchased Began digitizing ~25 million glass slides in archives Slidelabels given barcodes 800,000 to 1MM slides produced annually 2016 Telepathology at JRSC In house cases scanned LIS Integration Telecytology Outside consults scanned 2017 Warren Alpert Center for Digital and Computational Pathology Expand digital archive Explore use of new technology for workflow efficiencies Enhance telepathology capabilities for clinical support and outreach FDA News Release-April 12, 2017 FDA approval and marketing of first whole slide imaging system for digital pathology

12 Implementation of Retrospective* Clinical Digital Slide Scanning Outside Reviews 8/2015 Surgical Resections and all FS (QA) 2/ In-house Biopsies 1/2016 Digitize Archive 7/2018 * Post sign out

13 Jan-15 Feb-15 Mar-15 Apr-15 May-15 Jun-15 Jul-15 Aug-15 Sep-15 Oct-15 Nov-15 Dec-15 Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16 Jul-16 Aug-16 Sep-16 Oct-16 Nov-16 Dec-16 Jan-17 Feb-17 Mar-17 Apr-17 May-17 Jun-17 Jul-17 Aug-17 Slides (n) Implementation of Retrospective* Clinical Digital Slide Scanning Slides Scanned Per Month Outside Reviews 8/2015 Biopsies 1/2016 2/2017 Surgical Resections * Recently signed out

14 Slides (n) Background Jan 2015 Dec ,901 slides scanned

15 Digital Pathology to Support OR Operations Josie Robertson Surgical Center (2016) 1133 York Avenue, NY, NY ,039 Surgical Cases 7 Surgical Services 65 Surgeons Operating One Pathologist for Frozen Section Diagnosis Operational Challenges for Pathology: Sub-specialty expertise to consult on difficult frozens Transporting glass slides for review of prior pathology material for frozens

16 Use of Digital Pathology to Support OR Operations Operational Challenge: Sub-specialty support to consult on difficult frozens Use of 3% increase in frozen volume average TAT = ~20 min opportunity to implement telepathology Transporting glass slides for review of prior pathology material for frozens use of digital archive to review prior cases 97% decrease in slide requests (YTD)

17 INTRA-OPERATIVE CONSULTATION: FS Q Q Josie-Robertson Surgery Center: Total volume: 6,433 Total cases requiring FS: 1,229 (19.1%) # of Cases with multiple FS: 728 (59.2%) Total # of Frozen Sections: 3,248 Total FS discrepancies: 8 (0.2%) Main Campus: Total volume: 38,086 Total cases requiring FS: 4,318 (11.3%) # of Cases with multiple FS: 1,558 (36%) Total # of Frozen Sections: 8,624 Total FS discrepancies: 17 (0.2%)

18 Design - Requisition forms were tabulated to identify the total number of cases, slides, and blocks requested from the slide archive over time - Frozen section glass slide requests for prior pathology material were tabulated for an off-campus surgery center starting January Our AP-LIS was queried for cases with documented review of available digital slides from prior specimens, then correlated to ordering of ancillary tests - Offsite physical pathology asset storage costs were comparatively calculated from (projected) - Turnaround time (TAT) was analyzed for cases with and without digital slides from prior specimens Slide Requests Survey Ancillary Testing Slide Storage TAT

19 Digital Pathology Experience Survey (71 respondents)

20 I check to see if digital slides are available before requesting glass slides

21 You view prior digital slides (when available) during clinical signout

22 Improvement in Pathology Material Management Digital Slides (n) Glass Slide Requests (n) ,369 Digital slides available 20,745 47,387 Glass slide requests 12, , ,334 1,426 25,000 20,000 15,000 10,000 5,000 Request for archive glass slides from the MSK Slide Library decreased by 93% as MSK s digital archive increased. Labor savings for Slide Library staff; 12% from 2016 and 17% from 2017 to Digital archive grew by 85% from 2016 to

23 Intraoperative consultation requests for prior archived pathology material showed a 100% decrease with implementation of retrospective digital slide scanning Frozen section glass slide requests

24 The availability of patient s prior digital slides help in deciding if repeat ancillary studies are needed on prospective pathology for the same patient

25 Cases with documented review of available digital slides from prior specimens shows decrease in IHC ordering 60.00% Cases with IHC Ordered 50.00% 40.00% 30.00% 20.00% 10.00% 0.00%

26 Pathologists did not order confirmatory IHC studies in up to 72% of cases with documented prior available digital slides ( ) Cases (n) IHC Ordered IHC Not Ordered

27 Benchmark Cost Savings Model for Immunohistochemical (IHC) Utilization Data based on years Mean # cases with IHC Not Ordered per year: 756 Median # IHC slides per case: 3 Average cost per IHC slide: $50 Anticipated savings per year: $113,400 Reference: Stephen S. Raab (2000) The Cost-Effectiveness of Immunohistochemistry. Archives of Pathology & Laboratory Medicine: August 2000, Vol. 124, No. 8, pp

28 Opportunity for Savings in Vendor Services Projected savings of approximately $274,000/year if vendor services for managing pathology material is reduced. 17% decrease in vendor services for retrieval, filing, and delivery services from most recent vendor.

29 The availability of digital slides improved your turnaround time

30 Review of average TAT from 59,571 surgical cases

31 The use of digitally scanned slides improve your clinical sign-out experience

32 Conclusions Metrics 1 Decrease in glass slide requests Practical Metrics Justifying Implementation of DP: 2 Decrease in ancillary workup for patients 3 4 Long term savings in glass slide storage costs Faster turnaround time for reporting cases 5 Benchmark Improved clinical sign-out experience Implementation of DP Offers Clinical and Operational Increase in Efficiency and Cost Savings

33 You would feel comfortable providing primary diagnosis using digital pathology, with retrieval of glass slides available upon request

34 You would feel comfortable providing primary diagnosis using digital pathology, without availability of glass slides

35 Digital Slide Equivalency and Efficiency Study Phase 1: Intraobserver Aims: Replicate/simulate clinical workflow benchmarking true glass slide sign-out to digital slide sign-out Compare equivalency and efficiency of glass and digital slides through actual reporting of true clinical workloads Eight Pathologists: Bone/Soft tissue Genitourinary Gastrointestinal Breast Gynecological Dermatopathology Matt Hanna API-PIS-2018

36 Signout Day Data Collection (glass and digital) Subspecialty Start/end of each case Case type (i.e. biopsy, resection) Part description # slides per case If ordered recuts/ss/ihc and # Technical Difficulties Diagnosis (i.e. top line, margin status, LVI/PNI, Stage-pT pn) Will snapshot cases after Day 1 for comparison Documenting review of prior material (case/part/slide) Document interruptions, if any (per case) Consultations

37 Intraobserver Equivalency (13 week wash-out) Diagnosis Margin status LVI/PNI pt stage pn stage Did you remember case? Select from above # Recuts/ancillary tests (which) Prior material review Phase 2: Interobserver (15 pathologists)

38 WSI supporting cancer genomics

39 WSI supporting cancer genomics

40 Pathology Consult Portal: Digital Consult Portal Expand MSK Pathology Outreach Program on Global Scale Bring New Patients to MSK Improve turnaround time for pathology consults Will accession glass slides and/or digital images Can reach places where pathology expertise is needed most ~10% of personal consults become MSK Patients ~30% of total pathology case volume are outside consults Mitigates handling large volume of physical slides Eliminates delays in waiting for glass slides to be sent to MSK Reduces risk of losing slides

41 MSK Universal Slide Viewer: Any Scanning Platform/file type Clinical Information i.e. Darwin, cbio Portal Pathology Consult Portal MSK Universal Slide Viewer Thomas Fuchs, PhD Laboratory Information System (LIS) Pathology AI Model (decision support)

42 Warren Alpert Center for Digital and Computational Pathology Co- Directors David S. Klimstra, MD Meera Hameed, MD Medical Director Victor Reuter, MD Director of Informatics Pathology S. Joseph Sirintrapun, MD, MA Director of Digital Pathology Yukako Yagi, PhD Director of Computational Pathology Thomas Fuchs, D.sc Senior Project Manager Jennifer Samboy, MHA

43 Goals for the Warren Alpert Center: Establish fully digital workflow for clinical service and education: Telepathology Consult Portal Integrate into clinical operations Explore novel technologies for digital imaging: 3D histology Partner with industry Computational Pathology for decision support: Machine learning Pathology artificial intelligence (AI)

44 Lessons learned in the use of digital imaging at Memorial Sloan Kettering Cancer Center It is not a matter of IF but rather WHEN Early adopters have and will pay a price Patience and determination is a virtue Demonstrate value (ROI) to leadership Create traffic with vendors Test, validate, establish metrics of success Engage your clinical, technical and laboratory staff incrementally Keep you eye on the future

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