DIGITAL PATHOLOGY SOLUTIONS Today versus tomorrow

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TECHNOLOGY IN THE MODERN SURGICAL PATHOLOGY
LABORATORY DIGITAL PATHOLOGY AND BEYOND
Victor E. Reuter, MD Department of
Pathology Memorial Sloan-Kettering Cancer Center
Disclosures none
reuterv_at_mskcc.org
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AUTOMATION IN THESURGICAL PATHOLOGY
LABORATORYOutline

• Define the current status in the AP laboratory
• Discuss opportunities for improvement
• Summary of how we are addressing these issues
• What this talk is not
• not a roadmap to be followed by all
• not a plug for any vendor
• not a technical talk but rather a practical
  approach to address the challenges at hand

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

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SURGICAL PATHOLOGY LABORATORYcirca 2009

• Manual labor-dependent
• - prosecting
• - histotechnologists
• - transcriptionists
• Diminishing work force
• - retirement
• - inexperience / licensure
• Stand-alone (FTE-dependent) equipment
• - multiple vendors without interconnectivity
• Batching of samples prevails

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SURGICAL PATHOLOGY LABORATORYcirca 2008

• End result
• - inefficiency
• - error prone
• - growth is FTE-dependent
• - large footprint
• - increased cost

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NEW TECHNOLOGY

• Implementationbecause we can
• versus
• Implementationbecause we should
• Needs assessment in an
• environment where
• there is resistance to
• change

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NEEDS ASSESSMENTnew technology

• The amount of tools available has increased
  dramatically but, for the individual laboratory
• Where am I?
• Where do I want to go?
• How do I get there?
• How do I know I am there?

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WHAT ARE THE INTERESTEDPARTIES TALKING ABOUT?

• Factors driving change (cost, safety,
  efficiency)
• Re-engineering workflow in the AP lab
• Disruptive innovation
• Corporate innovation as an engine for change
  (taking advantage of opportunities to make a
  buck)
• The concept of medical imaging (or the
  convergence of radiology and pathology)
• The Pathologist and personalized medicine
• Exportablility of personal medical information

• www.cap.org Futurescape
• www.labinfotech.com
• www.labsoftnews.com
• www.pathologyvisions.com

workflow , informatics, automation, QA, digital
microscopy
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SPECIMEN ACCESSIONworlflow improvements
Integration of electronic medical record
with the laboratory information system

• Minimize data entry at accession
• - Patient information
• - Order entry
• - Site / procedure
• Potential benefits
• - Eliminate double-entry
• - Create efficiency
• - Decrease potential for error

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PROSECTINGworkflow improvements

• Templates for gross description
• - standardization
• - avoids unnecessary text
• - decreases need for transcription
• Bar coding of blocks
• - avoids handwriting
• - saves time
• - promotes patient safety

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BAR CODING OF SLIDES

• Functionality
• Slide tracking (lab, MD office, conference,
  send-out)
• Decreases search time ( 4 hrs per week)
• Decreases calls and e-mails between parties
• Savings
• 1 FTE in histology
• 1 FTE in the office

- Cost saving 2.50-3.00 per case - Patient
care error reduction - Custodial responsibility
University of Washington Medical Center, Grimm et
al
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TISSUE PROCESSORS

• Standard processors
• Tried-and-true
• Customized programs
• Prolonged processing time
• Large footprint for volume of work
• Must be vented
• Xylene-dependent

• Rapid processors
• Relatively new
• Customized programs
• Shorter processing time
• Smaller footprint for volume of work
• Most do not need venting
• May be xylene free

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Other technologies thatpromote efficiency

• automatic embedding
• automatic slide sectioning
• integrated slide stainer

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TEMPLATES AND SYNOPTIC REPORTSuseful features

• Flexibility to adapt to voice recognition or
  keystroke-enabled templates
• Unlimited number
• Customized to individual needs
• Ability to include additional text
• Ability to modify templates over time
• Laboratory-wide applicability
• Gross dictation
• Microscopic/Final diagnosis (CAP compliance)

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SO WHY I AM TALKING ABOUT TECHNOLOGY IN GENERAL
WHEN THIS IS A MEETING DEDICATED TO IMAGING?

• Our needs are many
• Our resources limited
• Pressing needs will trump others
• There is competition for our attention
• Must demonstrate return on investment
• Must set benchmarks

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DIGITAL PATHOLOGY

• Potential applications at MSK
• comprehensive digital pathology sign-out
• remote pathology (BR, C, BIC, 53rd St)
• second opinion consultations
• frozen section consultation
• signal quantification
• archiving and retrieval
• education
• QA

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Comprehensive Digital Pathology Sign-outwork
volume at MSKCC

• Cases
• - Internal 39,250
• - DC 17,000
• HE Slides
• - Internal 520,000
• - DC 169,000
• IHC slides
• - Internal 104,000
• Total slides 793,000 (2.5 increase/yr)

Scanning volume 793,000 slides / 365 days 2173
slides per day (24/7)
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SECOND OPINION CONSLUTATIONS

• Ask the expert
• Consultation portals
• At MSK it represents 30 of workload
• Shipped by currier (approx. 65 per day)
• Obliged to return to primary institution
• of slides is variable (1-dozens)
• - of key slides minimal

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DIGITAL ARCHIVES A Study of diagnostic accuracy
with evaluation of multiple morphologic
parameters in breast lesions

• Aim
• Detailed assessment of the morphologic parameters
  included in a breast pathology report
• Planning of a digital archive intended for
  clinical use
• Estimation of its storage requirements
• Study
• 220 cases (119 CB, 73 EXS, 28 MS, 1830 slides)
• Breast pathologist selected relevant slides
• for scanning

Petroff et al, MSKCC
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Invasive carcinoma
Intraobserver
Petroff et al, MSKCC
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Carcinoma in situ
Intraobserver
Petroff et al, MSKCC
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Second opinion cases inBreast Pathologystorage
issues

• 200-800 MB per slide
• Nearly one terabyte in 2 months
• Possible to reduce scanned slides
• only 1-3 per case
• Archived for life
• Compression

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Wynveen et al, MSKCC
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Wynveen et al, MSKCC
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AE1/AE3
Calponin
Wynveen et al, MSKCC
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BACKGROUND Prostate Cancer Parameters

• Grading
• Gleason grade and Gleason score
• Clinically significant categories
• Size
• Percentage or mm
• Perineural invasion

Kattan MW et al. J Urol 20031701792-1797
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BACKGROUNDGleason Grading Reproducibility Among
GU Pathologists
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DESIGN50 challenging core biopsies

• 4 Urologic pathologists
• 1 Gleason grade (GG1)
• 2 Gleason grade (GG2)
• Total Gleason score (GS)
• Perineural invasion (PNI)
• Percentage () with cancer
• Size (mm)
• Media
• Digital whole slide microscopy
• Routine microscopy

Difficult to grade, small focus. Single level
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CLINICALLY SIGNIFICANT GLEASON SCORE GROUPS (6
v. 7 v. 8-10)
p0.15
Rodriguez et al, MSKCC
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INTRAOBSERVER AGREEMENT
Rodriguez et al, MSKCC
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REMOTE PATHOLOGYFrozen sections

• Subspecialty support required
• Saturday OR schedule
• off-site surgery

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DIGITAL PATHOLOGYFrozen Section Validation Study

• Methodology
• Retrospective study
• Actual frozen section digitized at 20X mag
• Pathologist provided with exact information
  received from the OR
• Site, clin info, specific question, etc.
• Evaluation performed at the pathologist desktop

Equivalence No deeper sections, no depth of
field, no consultation, etc.
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DIGITAL PATHOLOGYFrozen Section Validation Study

• Cases 174
• Specialties Br, GI, GU, GYN, HN, Neuro,
  Thor, BST
• Cases per specialty 10-30 (mean 22)
• Participants 20
• Encounters 438
• Time 10-600 sec (mean 133 sec)

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DIGITAL PATHOLOGYFrozen Section Validation
StudyResults
correct / all cases correct / all
cases minus deferred cases
Park et al, MSKCC
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Park et al, MSKCC
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DIGITAL PATHOLOGYInstitutional support (Frozen
Sections)

• First year investment for 17 pathologists
• Laptop ThinkPad T500
• Display screen LVO L222 22 DVI
• Home broadband service
• Wireless broadband service
• Yearly broadband support 22,440.00
• Service expanded to additional pathologists as
  needed

64,804.00
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ROBOTIC MICROSCOPY AND WHOLE-SLIDE IMAGING FOR
PRIMARY FROZEN SECTION DIAGNOSISUniversity
Health Network, Toronto, Canada

• 350 cases diagnosed by RM (11/04-9/06)
• 633 cases diagnosed by WSI (9/06-present)
• Turnaround time RM 19.98 vs. WSI 15.68 min (p lt
  .0001)
• Review time RM 9.65 min vs. WSI 2.25 min (p lt
  .00001)
• Diagnostic accuracy 98 (RM and WSI)
• Overall deferral rate 7.7
• Discrepant cases mostly minor (tumor type),
  without impact
• Pathologist satisfaction (WSI gt RM)
• Average files size 36 and 132 Mbytes per slide
  (sectn / smear
• Evans AJ et al. Hum Pathol 2009 40 1070-1080.

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RETENTION OF FROZEN SECTION VIRTUAL SLIDE FILES
QA with Final Pathology
No discrepancy
Discrepancy
Educational value?
Minor no impact on patient care
Major with patient care impact
Save At the discretion of pathologist
review continued storage at years end
Delete 6 weeks after path is reported
Retain for 1 year
Retain indefinitely
Evans AJ et al. Hum Pathol 2009 40 1070-1080.
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Increasing compression
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Increasing compression
557 MB
419 MB
320 MB
File size
131
101
7.51
Compression ratio
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Remote Pathology at MSKCCconsultation between
satellite sites

• Sub specialized environment
• Care delivered at multiple sites
• Redundancy is expensive but required
• Dermatopathology support for mos surgeons

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TELEHEALTH RAPID BREAST CARE CLINIC (UltraClinics
Process)
Digital Mammography (Teleradiology)
Surgical consultation
Biopsy
Mammography
Breast Care
Rapid tissue processing Virtual slide scanning
Laboratory report
Telemedicine clinic
Cancer specialist Teleconsultation
Telepathology
Lopez AM et al. Hum Pathol 2009401082-1091.
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EDUCATION

• Educational and business models
• Institutional study sets
• Webinars
• Global classroom
• Credentialing / CME / MOC
• SAMS, APECS

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SIGNAL QUANTIFICATION

• Research and clinical environments
• Therapeutic decision making based on qualitative
  and quantitative antigenic features
• - FDA approval
• - Validation
• - Standardization
• - Reproducibility

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Manually scored as 2/3
Classified as 2 by IA FISHnot amplified
Classified as 3 by IA FISHamplified

• IA provides a more objective HER2 result
• and can aid in selecting cases for FISH
• Alogrithm may need to be optimized

Wen et al, MSKCC
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Proliferation rate in Mantle cell lymphoma

• 64 cases with annotated clinical
• data submitted to DMC and QIA
• Agreement rate 95
• Sensitivity and specificity of QIA
• 100 and 94
• 5 yr event free and overall survival
• PI lt30 81 and 93
• PI gt30 16 and 62

Schaffel et al, MSKCC
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Computer aided diagnosis (CAD)
LOOKING FAR INTO THE FUTURE

• Pathologist in a box
• QA/QC
• Cytology
• Research

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PARTICIPANTS IN OUR DIGITAL PATHOLOGYEFFORTS AT
MSKCC
Techies Evan Stamelos Cyrus Hedvat MSKCC IT Dept
Heme Team Julie Feldstein Oscar Lin
GI Team Laura Tang Jinru Shia Nora Katabi Evi
Vakiani David Klimstra
Frozen Section Team Kay Park Jason Huse Ron
Ghossein Andre Moreira Natasha Reckman Diane
Carlson Rob Soslow Bill Travis
GU Team Samsom Fine Anu Gopalan Satish
Tickoo Hikmat Al-Ahmadie
Fellows Gabe Sica Paula Rodriguez Ali Amin YH
Wen Christine Wynveen Linda Petroff
Breast team Edi Brogi Melissa Murray Dilip
Giri Karuna Garg Violetta Barbashina
Photography team Ali Manzo Kin Kong
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DIGITAL PATHOLOGYInstitutional support

• Firewall Bluecoat
• NAS technology EMC Celerra
• Capacity 40TB on a 300TB EMC Celerra
• Speed 8Gbit links to the EMC
• Hard drives SATAs, 7200 RPM
• Back up now combo of netbackup to tape and
  replication to the DR site
• Back up future replication to DR site
• Our cost 3,000.00/TB
• Failure protection Raid5 with hot swappable
  drives and redundant HW on each server

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AUTOMATION IN THE ANATOMIC PATHOLOGY
LABORATORYThe dangers of being an early adopter

• investment in technology will be more difficult
  to justify (limited data)
• nothing works perfectly out of the box
• your costs will be higher
• you will have to deal with the traditionalists

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AUTOMATION IN THE SURGICALPATHOLOGY
LABORATORYsummary

• The SP laboratory will be automated
• Adoption will be driven by internal and external
  forces
• Early adopters will pay a price
• At present, the best return on investment is in
• Synoptic reporting
• templates / voice recognition
• Bar codes
• Rapid tissue processor
• Digital pathology

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SUMMARY

• Market forces are driving the need for change in
  many aspects of laboratory operations
• - confluence of innovation and need
• Digital pathology is a key element in
  modernizing an academic pathology laboratory
• Implementation of digital pathology is not a
  matter of if but rather when
• - competitive environment
• Unmet needs
• - LIS integration - Regulatory
• - Browser - Scan time
• -DICOM standards

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AUTOMATION IN THE SURGICALPATHOLOGY
LABORATORYsuggestions

• Get involved
• Perform needs assessment and prioritize
• Establish value to higher ups
• Return on investment
• Create traffic with vendors
• Visit laboratories that have implemented the
  technology under consideration
• Validate internally / parallel test
• Be patient. Beware of the dinosaurs!

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reuterv_at_mskcc.org