1. Operational Considerations in Implementing Digital Pathology Pathology Visions 2009 Walter H. Henricks, M.D. Cleveland Clinic

2. Walter H. Henricks, M.D. Digital Pathology is Extra Work Implementing digital pathology in practice involves more than just viewing digital representations of glass slides. Digital pathology workflow requires substantial extra effort, time, and investment over and above routine tissue processing, slide creation, and slide review in pathology.

3. Walter H. Henricks, M.D. Digital Pathology is Extra Cost Investment is necessary for the functions specific to digital pathology: –Image capture/digitization –Image transmission –Image display and viewing –Image storage – short term and long term Investments include capital, labor, and other expenses.

4. Walter H. Henricks, M.D. The value proposition for digital pathology hinges on benefits that outweigh the costs associated with the incremental work and investment required.

5. Walter H. Henricks, M.D. Elements of Surgical Pathology Work Flow Relevant to Digital Pathology Notification of case availability Accessioning into AP LIS Distribution of case to pathologist Slide review and interpretation Generation of report Additional studies if needed

6. Walter H. Henricks, M.D. Digital Pathology Workflow is Divided Between WSI System and AP LIS Notification of case availability – maybe WSI Accessioning into AP LIS – AP LIS Distribution of case to pathologist – WSI, APLIS Slide review and interpretation – WSI Generation of report – AP LIS Additional studies if needed – AP LIS With time, integration between WSI and AP LIS should increase.

7. Walter H. Henricks, M.D. Notification of case availability Routine pathology Slides are created in the laboratory Consult slides arrive with necessary (hopefully) paperwork Digital pathology Slides do not arrive Slides must be scanned – successfully – to create digital slides Some type of notification so that the recipient knows when digital slides are available or “received”

8. Walter H. Henricks, M.D. Accessioning into AP LIS – Digital Consults Routine pathology Lab personnel match slides with information in accompanying documents to confirm: –Patient/case ID and slide labels match –All slides are received –Slides are not damaged –All necessary accompanying information is present Case is accessioned into LIS Digital pathology Lab personnel need access to required information (see next slide) in order to accession case –Electronic requisition? –Available in slide viewing software? –e-mail? Lab personnel need access to the digital slides in order to confirm: –Patient ID and slides match –All expected slides are available –No obvious scan problems Case is accessioned into LIS

9. Walter H. Henricks, M.D. Information Required for Accessioning Surgical Pathology Cases Patient ID and demographic information Description of specimen/ # of glass slides submitted Clinical history Specific questions or requests for pathologist Pathology report (if referral case) Patient insurance/billing information For digital pathology consultations, a mechanism is required for getting this information to the case accessioner and to the pathologist

10. Walter H. Henricks, M.D. Distribution of case to pathologist Routine pathology Slides, working draft report from LIS, and other paperwork with necessary information (e.g. requisition) are delivered to pathologist Digital pathology Pathologist needs notification that case is waiting. –Working draft from LIS may be delivered to pathologist Pathologist needs to see other necessary information –Access to scanned documents? –Printout of electronic requisition?

11. Walter H. Henricks, M.D. Pathologist slide review and interpretation Routine pathology Pathologist places slides on microscope and navigates slides at own pace Pathologist arrives at diagnosis based on review of glass slide Digital pathology Pathologist accesses digital slides in viewer system and views on monitor –Needs to know how to locate digital slides for each case Pace of navigating slides is determined in part by system response time for viewing slides May need to defer diagnosis to glass slide review

12. Walter H. Henricks, M.D. Some digital pathology cases will need to be deferred to glass slide review Image capture errors and failures (e.g. focus, tissue finding) may result in unreadable digital slides Digital images are great but at the limit not as good as high quality microscope optics Pathologist comfort level will be greater with microscope Some cases will require additional sections or studies, such as special stains in order to work up the case appropriately –Also true for routine pathology, but digital pathology workflow must accommodate

13. Walter H. Henricks, M.D. Generation of pathology report Routine pathology Creation of pathology report in LIS typically accomplished through: –Dictation with transcription –Direct entry –Speech-to-text Digital pathology Options for creation of report in LIS are the same If at remote location, pathologist needs access to LIS and/or transcription services, or a procedure is needed for documentation and eventual report Should report note that digital pathology was used in the case?

14. Walter H. Henricks, M.D. More pathologist time per case will be required for digital pathology Using digital pathology will be a slower experience for a pathologist than is moving a glass slide around on a microscope. –Navigation of and viewing of microscopic fields by virtual microscopy –System and network response times (latency) Additional time per case could be expected to increase with increasing case complexity (number of slides, amount of tissue per slide).

15. Walter H. Henricks, M.D. Experience will be required for pathologists to acquire skills and to gain comfort in making diagnoses from digital slides Most pathologists have little to no training or experience in digital pathology. Expertise in microscopy does not automatically or immediately translate into digital pathology proficiency. Digital pathology “artifacts” are present in addition to usual histology artifacts

16. Walter H. Henricks, M.D. Laboratory Accreditation Requirements for Digital Pathology The College of American Pathologists checklists have requirements for “Telepathology” The requirements are applicable to situations when an interpretation based on an image is included in a formal report and applies to: –Primary diagnoses –Frozen section interpretation –Second opinion consultations –Ancillary techniques that involve image interpretation

17. Walter H. Henricks, M.D. Laboratory Accreditation Requirements for Digital Pathology (cont’d.) Method to ensure correct patient and image identification and match Access to pertinent clinical information at the time of case review Policies for appropriate and intended use(s) of equipment Training procedures Inclusion of digital pathology in quality management plan Data confidentiality and security measures

18. Walter H. Henricks, M.D. Cost/Benefit and Justification Considerations

19. Walter H. Henricks, M.D. Digital Pathology Costs WSI scanning system Data storage and server capacity Network bandwidth High resolution viewing monitors Dedicated web servers Interfaces to other systems such as the AP LIS FTEs for scanner operation and QA FTEs for IT technical support

20. Walter H. Henricks, M.D. Justification for Digital Pathology Most of the benefits of digital pathology are intangible and without specific incremental revenue attached. –Improved quality and efficiency of patient care –Facilitated communication with clinical services –Filling of gaps in service coverage –Access to subspecialty pathologist expertise –Support of institutional telemedicine programs

21. Walter H. Henricks, M.D. Justification for Digital Pathology – Clinical Applications Frozen section coverage at remote or low volume locations Frozen section expert consultation Second opinion consultation – formal, external Second opinion consultation – informal, intradepartmental QA – e.g. second review all new malignancies Clinician consultation – case conferences, informal discussions Primary diagnosis (eventually)

22. Walter H. Henricks, M.D. Metrics to Support Digital Pathology Justification Volumes of slides scanned – use of system is proof of value – educational, clinical, research Number of educational courses, conferences, etc. enabled by digital pathology Number of digital pathology cases that enabled subspecialty consultation as added value Assessment of pathologist efficiency by eliminating travel and/or need to courier slides – hours and miles saved

23. Walter H. Henricks, M.D. Metrics to Support Digital Pathology Justification (cont’d.) Reduced time and costs associated with packaging and sending glass slides Improvements in TAT of diagnosis availability when digital pathology used More rapid TAT on “technical component” studies, e.g. IHC Clinician satisfaction measurements related to service improvements enabled by digital pathology

24. Walter H. Henricks, M.D. Factors That Affect or Degrade Slide Scanning Throughput Scanning resolution (20X vs. 40X) Amount of tissue on slide Inefficiencies related to batch mode processing Time to load and off-load slides Re-scanning slides that did not scan properly (many reasons) QA of scanned slides Human factors

25. Walter H. Henricks, M.D. Implementation of digital pathology is truly “more than meets the eye” Viewing digital slides is only one part of many considerations that go into implementing a digital pathology program. Each step of workflow must be carefully examined to address operational requirements unique to digital pathology. Digital pathology represents considerable investment, and value depends on benefits that may be difficult to monetize.