J. Mark Tuthill, MD Division of Pathology Informatics Henry Ford Hospital Detroit, MI

Transcription

1 Realizing Effective Digital-Enabled Anatomic Pathology Workflow The Henry Ford Experience J. Mark Tuthill, MD Division of Pathology Informatics Henry Ford Hospital Detroit, MI Digital Pathology and AI Workshop Columbus, OH December 7-8, 2018

2 Objectives 1. Understand digital integration prerequisites 2. Present examples of operational systems used and digitally integrated at HFHS 3. Highlight common strategies the lead to success 4. Describe the integration of WSI including bar code harmonization

3 Philosophical Hypothesis We can integrate AP workflow so that it models efficiency of the clinical laboratory What are the pre-requisites? What is the low hanging fruit? Sequence What are the technology gaps? Advanced robotics and pipeline development Automation of manual processes

4 Operational Systems Digital Integration

5 Information Technology Lab Information System PATHOLOGISTS TECHNICAL & SUPPORT STAFF

6 Wired Sunquest : Lab and CoPath Histotrak HLA MAS POC Aqueduct Hematology Lane Faxing Epic Syapse LAB PORTAL Atlas SCANNING Scantron Surg Path Reqs Cytopath Reqs Clin Path Reqs Outreach Documents Molecular Pathology and NGS APOLLO Pathpacs Store AP Req Scans Store Clin Path Req Scans Integrate External AP Results Telepath Integration Associate Imaging to Reports Interface to acquisition devices Cameras (1-2 M records/yr) - Gels -Microbiology Digital Pathology Roche MikroScan Digital Cameras HEALTHSTREAM Training (HFHS U) Competency LAB USER S GUIDE pathology.hfhs.org/lug TISSUE BIOREPOSITORY DOCUMENT CONTROL Master Control

7 Clinical Pathology Systems Functional Areas Chemistry Hematology Coagulation Urinalysis Blood Bank Microbiology Serology Virology HLA Molecular Genomic Pathology Point of Care Glucometers >650 Coagulation clinics Applications SunquestLab SMART barcoded specimen tracking, management. and archiving >140 Instrument Interfaces via Sunquest Instrument Manager (SIM) Autovalidation Macroscheduler automated jobs Histotrac: HLA laboratory system MSQL Report Writer w/ Crystal Results transmitted to EPIC Beckman Automation Line; Conexus; Remisol

8 Anatomic Pathology Systems Functional Areas Histology Molecular Pathology Illumina NGS Cytology Frozen Room Autopsy CP Integration Special Hematology Flow Cytometry Immunohistochemistry Microbiology Applications Sunquest CoPath Biomaterial tracking system (BTM) Scantron: requisition scanning mtuitive: synoptic checklists JFCC reporting via epath Barcoded LEAN production Apollo Digital photography Telepathology: Mikroscan WSI: Ventana Virtuoso, Mikroscan Ventana Connect Dako Connect Tens of molecular pathology applications

9 Other LIS Applications and Operations Functions Atlas Portal: Outreach EMR; order entry and result reporting Scantron: Document scanning for regulatory retention LUG: Laboratory Users Guide Lane Faxing: supports all Health system laboratory faxing BTM: Tissue Biorepository IT Service Now: Helpdesk; PI Change Control database for compliance Apollo PathPACS: image storage integrated with both Sunquest systems (Lab & CoPath)

10 Road Map for Digital Workflow The Big Picture Pre analytic Prior to receiving or analyzing the sample Preparing samples for analysis Analytic The process of analyzing the tissue Post analytic The reporting of diagnostic information Preparing for additional analytic studies

11 Prerequisites for Anatomic Pathology Digital Workflow Sophisticated electronic medical records system Electronic orders interface for Anatomic Pathology Bar code labeled assets with the laboratory Assets with unique identifiers Development of robotic technologies *Grossing* Embedding, Sectioning Tissue transport Sampling Storage systems: cassettes and slides

12 Prerequisites for Anatomic Pathology Digital Workflow Sophisticated electronic medical records systems Such systems will enable clinical orders to be sent to the anatomic pathology information system as well as supporting: Decision support Gathering of accurate and required information Positive patient identification Generation of laboratory ready labels to the point of service Tracking of samples to the laboratory including monitoring of conditions

13 Prerequisites for Anatomic Pathology Digital Workflow Electronic orders interface to the Anatomic Pathology Laboratory Information System (AP-LIS) Similar to the clinical laboratory, a flow of orders to the LIS will enable: Sample receipt Tracking Routing Analytic Processing Automation of several elements of case accessioning Decrease errors Increased throughput

14 Prerequisites for Anatomic Pathology Digital Workflow Bar code labeled assets within the laboratory This is most essential early prerequisite to achieve automation within the laboratory Bar coding of assets allows for: Bar code driven workflow Identification error reduction due to mislabeling Improved efficiency by reducing manual labeling Automation of subsequent activities Integration whole slide imaging, interface devices This is the key requirement for all automation

15 Prerequisites for Anatomic Pathology Digital Workflow Bar code labeled assets within the laboratory Critical for each asset to have an unique ID embedded in the bar code This will allow each block and slide to be managed uniquely supporting (Assets) Sophisticated routing Tracking of assets Digital Pathology (unique ID on slides will be essential!) Systems interfaces Without uniquely identified assets the clinical laboratory could not have achieved the level of automation currently experienced

16 Examples of Anatomic Pathology Digital Workflow Real World Examples and Status Updates

17 Examples of AP Digital Workflow Automation of histology orders (stain protocols) Interfaced immunostain orders to automated immunostain platform Bar code labeling automation Automated production of cassettes at accessioning Cassette driven generation of labeled slides Tracking, routing and storage Automated tissue embedding Automated microtome's

18 Examples of AP Digital Workflow Automated block sampling Automated slide sampling Laser capture micro dissection Conveyor belt systems, tubes, roving robots: routing Slide collation robotics Automatic diagnostics Whole slide imaging algorithms for immunostains quantification Automated pap smear readers

19 Examples of AP Digital Workflow Histology Protocols Automated ordering histology protocols for different sample types at case accession When a particular part is accession the appropriate blocks and initial stain orders are generated Initial billing fee codes are applied Histology logs are electronically sent and printed providing early notification of work This has increases efficiency and allows for LEAN processes Work is standardized Revenues were enhanced through better charge capture This is not easy and required iterative re-work and constant attention to defects to get the most satisfactory end result

20 Examples of AP Digital Workflow Real Time Labeling Essential first step to widespread AP automation As previously stated the implications of bar code labeled assets drives all other processes By themselves, the impact of automation of cassette labeling following by slide label generation are profound

21 Barcode Specified Work Processes This case is submitted in 3 specimen containers consisting of: part A - sigmoid colon biopsy, part B - transverse colon biopsy and part C - stomach biopsy with standing preorder for Helicobacter pylori immunostain. Protocol driven information is reflected in the slide labels dictating 2 levels cut for each part. 4 The stomach biopsy protocol, part C, calls for an additional 2 blanks slides to be cut, one for the immunostain & a 4th left unstained. 21

22 Outcome With 'real-time labeling' the batch slide label printing process has now been entirely eliminated Specimen misidentification rates have been reduced Workflow efficacy in the histology lab has increased as cassette reading defects have been eliminated Barcode reading defects required the histotechnologist to manually type in cases numbers, leading to increased risk of patient misidentification

23 Results: Misidentification Rates % % % 1 Number Mis-ID Defects Percent of Cases Baseline Linear Bar Codes (Jan. 2007) 2D Bar Codes (June 2012)

24 Examples of AP Digital Workflow Specimen Tracking and Routing Allows us to record the location and status of specimen assets (parts, blocks, slides, etc.) as they are processed and move through the pathology laboratory All components of a case can be tracked from when they are accessioned on through to storage or eventual disposal Tracking allows for us to locate case assets and identify who has handled them and where assets have been (i.e. history) I will not address routing and processing protocols as it applies to conveyance systems which we are not yet using

25 Specimen Tracking Technology AP-LIS: CoPath Plus v6.0 (6.1) (Sunquest Information Systems, Tuscon, AZ) CoPath Specimen Management Routing and Tracking (SMART) module InfoMaker reports were created using PowerBuilder software (Sybase, Dublin, CA).

26 Design Specimen Tracking We defined specimen points of tracking (SPOTs) in the AP- LIS dictionary Each SPOT is linked to a specific workstation as defined on the health system s internal network As each asset is scanned and processed location, scan time, status, and associated user data are automatically recorded Standard tracking tools allowed us to monitor assets in realtime

27 * AP Workflow Design * * * * * * * * * * * * *

28 Design: SPOT Implementation Histology Lab Pathologists Currently 145 SPOTs have been defined

29 Tracking Activities Asset Manager Specimen Discard Specimen Tracking Update Slide Status Update View/Update Specimen Tracking Asset Reconciliation Tracking Reports Asset Location Report Parts/Blocks/Slides at a SPOT Parts/Blocks/Slides Aging Report Scan History Log Specimen Tracking Scan Errors SPOT Turnaround Time Report Unique ID Report Some functions are workflow specific while others can be utilized at multiple points in the process

30 Parts/Blocks/Slides Aging Report Lists the time elapsed since the most recent tracking event Can be used to show which specimen assets have been at a workstation the longest Useful for when: o Blocks unaccounted for in histology o Slides unaccounted for by the pathologist

31 Parts/Blocks/Slides Aging Report Lists the time elapsed since the most recent tracking event Can be used to show which specimen assets have been at a workstation the longest Useful for for when: o Blocks unaccounted for in histology o Slides unaccounted for by the pathologist

32 Scan History Log Lists all tracking events for for an asset and shows where each event occurred This report can be a useful QA tool can tell if users are compliant with scanning specimen assets Can identify scanning errors due to inappropriate case editing

33 SPOT Turnaround Time Report Displays the time between when assets were tracked at one SPOT (i.e. Accessioning) to when they were tracked at the next SPOT (i.e. Grossing) This can be used to find out how long it takes assets to be processed from one workstation to another

34 Workload Reports Scan events can be tracked at individual SPOTS and users Allows us to provide workload and productivity data for lab managers Example: Slide counts by microtomy person

35 Asset Reconciliation Allows the user to reconcile the assets in hand with the assets assigned to a case Can be use iteratively Gross Accession Embedding Foldering

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39 Examples of AP Digital Workflow Automated Staining Platforms Perhaps the most commonly automated process in the current AP lab Including automated cover slipping This saves hundreds of man hours per year Has more consistent results versus manual staining and cover slipping Digital interfaces with AP LIS will further enhance productivity and decrease errors

40 Automated Immunostaining Interface Design An HL7 interface was created between CoPath and the Dako autostainer Link 48 platforms Allowed IHC orders placed in CoPath to be directly transmitted and received by the DakoLink instrument control software; used Dako labels Our CoPath LIS was upgraded to version 6.0 which provided the capability to uniquely identify and track each case assets Assign unique identifiers to each and every case asset (i.e. parts, blocks, and slides) With this in place, unique slide IDs (linked to IHC orders in the AP-LIS) were transmitted to Dako autostainer control software Dako autostainer instruments could then read and utilize native CoPath labels

41 New workflow after deployment of the automated stainer interface Special stains CoPath Stains Ordered Slide are cut & labeled Interface Creates HL7 message Slides placed onto instruments Slide labels scanned IHC Slides processed

42 CoPath Dako New Workflow 1. Stains are ordered in CoPathPlus. 2. Stain orders are released to the interface on demand or scheduled. 3. Interface creates an HL7 message and delivers to Dako 4. Message is routed to instrument. Slide labels print from CoPath. 5. Slides are cut in the laboratory and Slide labels print from CoPath and labels are applied to slides. 6. Slides are placed into the instrument. Label is scanned by instrument which indicates the reagent stain workup. 7. Slides are processed.

43 From CoPath Printer to Slides to Dako Bypassing Dako Relabeling

44 Results With elimination of relabeling the slides and dual order entry through automation markedly decreases assay run time This saves upward of ~700 hours of manual effort per year while eliminating errors, improving patient safety and improving laboratory throughput Increases order accuracy by reducing keystroke errors. Enhances operational efficiency by automating processes. Enforces safe, consistent, efficient handling of specimen.

45 Examples of AP Digital Workflow AP EMR Orders Interface Project initiated to transmit AP orders from our EMR to CoPath This will solve several problems: Elimination of unsolicited results as orders will be fulfilled in the EMR Proper encounter selection Routing to provider inboxes Better tracking or AP tissue More efficient accessioning ADT, MD, Part Type, ICD, Clinical History and ask at order entry questions will be transmitted from EMR to CoPath

46 AP Orders Interface Project initiated to transmit AP orders from our EMR direcdtly to CoPath Impact based on time studies 1.5 minute average decrease in case accession 100,000 cases as a baseline for our math Savings of 2500 hours Minimum of $50,000, direct cost savings! Time savings doesn t include elimination of the complexities of misaccessioned cases and required resolution Elimination of defect in encounter selection alone will have huge impact

47 Examples of AP Digital Workflow Digital Pathology Not just whole slide imaging! (WSI) Distributed microscopic images Distributed EM Gross images Scanned documents Image analysis Clinical lab images: gels, plates, hematology analyzers Cytogenetics analysis Digital Pathology is: digitally capturing, storing, moving, analyzing, interpreting tissues (and other assets) submitted to the laboratory for the purpose of diagnosis, clinical communication, documentation and quality assurance

48 Apollo EPMM Implementation Apollo EPMM Image management provides: Expandable EMC SAN based storage Access and management for all existing image-generating devices Security management for users Permission-based logon, very nuanced Thick-client and Thin-client access LIS integration Interfaces for ADT and images Images to be send to the EMR via AP-LIS (CoPath) Sophisticated device integration including interfaces and file mover services

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50 TECHNOLOGY File mover services leveraged Grossing stations Apollo EPMM LIS Integration Autopsy suite Autopsy suite Specimen X-rays Robotic Telepathology Document Scanners

51 Final Workflow Cases accessioned into CoPath ADT sent to Apollo Images acquired for case automatically stored in Apollo Images links are sent back to CoPath (or not) as results Those returned are configurable: Associated with the case Embedd into the report Images viewable in Apollo or CoPath Report send to EMR with or without images as desired

52 Examples of AP Digital Workflow WSI: Drivers for HFHS Maturity of the WSI technology platforms Improved performance Decreasing costs The need for a distributed digital pathology workflow to support diagnostic studies Move images not glass! Loss of support for our robotic telepathology platforms The desire to adopt cish and image analysis for diagnostic panels

53 Decisions and Goals Stand up technology to replace robotic telepathology Selected Mikroscan as a vendor Stood up four D2 systems in each hospital to allow for telepathology support of intraoperative consultation Select WSI partner for cish analysis and distributed diagnostic imaging Selected Ventana Roche as a partner Implement iscan Coreo and Coreo HT platforms Interface these platforms with Sunquest CoPath Validate the Ventana Ultra cish platform Harmonize bar code labeling symbologies so that CoPath generate bar codes labels would be used Integrate this technology into CoPath and Apollo workflow

54 TECHNOLOGY File mover services leveraged Grossing stations Apollo EPMM LIS Integration Autopsy suite Autopsy suite Specimen X-rays Whole Slide Imaging Document Scanners

55 Prerequisites for Interfacing WSI Requisite hardware and software for WSI capable of using HL7 messaging Network attached storage solution Network bandwidth We had WSI in place since January 2016 An LIS capable of communicating with WSI systems via HL7 Electronic histology orders used for all histology processes Bar code labeled assets with unique ID s

56 Value of Interfacing WSI Immediate case access by pathologist No annotation Significantly more data is populated Part, Block, stain Patients details: age, sex, DOB; Assigned pathologist Leveraging bar code technology Case available to pathologist immediately upon successful scan No need to annotate and release

57 Past Setup Stain orders Dako Stain status updates CoPath Image orders SAM Image orders Apollo Imager Image results Image results Sunquest Application Manager (SAM)

58 CoPath Dako stain orders Stain status updates Ventana stain orders Roche Setup SAM Dako stain orders Dako Stain status updates Dako & Ventana stain orders Ventana Stain status updates Ventana Image Results Dako Ventana Connect Image orders Image results Image orders Image results Apollo Imager Sunquest Application Manager (SAM)

59 Roche Setup Ventana stain orders from CoPath Benchmark Ultra Ventana Connect Ventana Stain status updates Dako & Ventana stain orders Ventana image results Virtuoso Ventana images Ventana images Coreo PC HT PC Dako & Ventana stain orders

60 iscan HT Digital Workflow Cases are created in CoPath at accession HL7 message is sent to Ventana Connect and onto Virtuoso Slides cut, stained and placed on HT for scanning Scanned images automatically associated with patient, CoPath accession and pathologist Scanned images ARE NOW available to be viewed through CoPath interface Select fields can be exported and integrated into the CoPath report using Apollo EPMM

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63 Summary Realizing Effective Digital-Enabled Anatomic Pathology Workflow

64 Summary Realizing Effective Digital-Enabled Anatomic Pathology Workflow Many aspects of AP can be digitally integrated More integration is available than meets the eye We don t count some of these that have a big impact Digital integration saves time, money and improves patient safety Very few gaps in robotic solutions remain Gaps will close Pricing will come down Build upon your foundations: sequence carefully!

65 Conclusion Philosophical Hypothesis tenable: We can integrate AP workflow so that it models the efficiency of the clinical laboratory!

66 Questions? J. Mark Tuthill, MD Division of Pathology Informatics Henry Ford Hospital Detroit, MI Digital Pathology and AI Workshop Columbus, OH December 7-8, 2018