Digital Pathology: Hype vs Reality Who Am I? I AM NOT STEPHEN HEWITT... DISCLOSURES Session Goals
ARE THEY JUST HYPE?
OR…
ARE THEY SIMPLY REALITY? HYPE!! Digital Pathology = Whole Slide Imaging? Imaging Modalities in Pathology Generic Surg Path Workflow – with Imaging
Specimen TAKE A Accessioning Grossing triage PICTURE?
TAKE A Microtomy Embedding Processing PICTURE?
Staining Case Microscopic SCAN/TAKE coverslipping post-processing analysis A PICTURE? & labeling and archival Generic Surg Path Workflow – with Imaging
Specimen TAKE A Accessioning Grossing triage PICTURE?
TAKE A Microtomy Embedding Processing PICTURE?
Staining Case Microscopic SCAN/TAKE coverslipping post-processing analysis A PICTURE? and archival & labeling Generic Surg Path Workflow – with Imaging
Specimen TAKE A Accessioning Grossing triage PICTURE?
TAKE A Microtomy Embedding Processing PICTURE?
Staining Case SCAN/TAKE Microscopic coverslipping post-processing A PICTURE? analysis and archival & labeling Telepathology is Digital Pathology Too!
→ REALITY! HYPE!! Pathology Informatics Publications and Digital Pathology
Publication Year Digital Pathology Other Informatics Total
2018 23 20 43
2017 30 21 51
2016 35 21 56
Total 88 62 150 15 From: McClintock DS et. al. A core curriculum for clinical fellowship training in pathology informatics. J Pathol Inform 2012;3:31 16 From: McClintock DS et. al. A core curriculum for clinical fellowship training in pathology informatics. J Pathol Inform 2012;3:31 Digital Pathology and Pathology Informatics REALITY! HYPE!! 20 From: McClintock DS et. al. A core curriculum for clinical fellowship training in pathology informatics. J Pathol Inform 2012;3:31 To properly implement Digital Pathology, you should be familiar with at least 61 of the 92 topics in this list!! “XYZ” Informatics
YOU MUST UNDERSTAND BOTH FIELDS!!! Prime Example!!
OSU could not go digital without the proper expertise!! REALITY! HYPE!!
Digital Pathology and the FDA
→ → Comparison of FDA Device Submissions
From: Abels E, Pantanowitz L. Current state of the regulatory trajectory for whole slide imaging devices in the USA. J Pathol Inform. 2017;8(1):23-25 PIPS – Indications for Use
in vitro diagnostic use interpret digital images of surgical pathology slides formalin-fixed paraffin embedded (FFPE) tissue
NOT intended for use with frozen section, cytology, or non-FFPE hematopathology specimens PIPS – Indications for Use creation and viewing of digital images of scanned glass slides appropriate for manual visualization by conventional light microscopy
responsibility of a qualified pathologist assure the validity of the interpretation of images obtained using PIPS Complete Whole Slide Imaging System
From: Abels E, Pantanowitz L. Current state of the regulatory trajectory for whole slide imaging devices in the USA. J Pathol Inform. 2017;8(1):23-25 FDA Medical Device – 510(k) submission
CURRENT:
FUTURE:
From: Abels E, Pantanowitz L. Current state of the regulatory trajectory for whole slide imaging devices in the USA. J Pathol Inform. 2017;8(1):23-25 FDA Clearance Requires Validation! CAP Validation Recommendations
→
→ CAP Validation Recommendations
Recommendations Grade 1 All labs should carry out their own validation EC
2 Validation should be appropriate for, and applicable to, the A intended clinical use and clinical setting in which WSI will be employed 3 The validation study should closely emulate the real-world clinical A environment in which the technology will be used 4 The validation study should encompass the entire WSI system B 5 Revalidation is required whenever a significant change is made to EC any component of the WSI system 6 Pathologist(s) adequately trained to use the WSI system must be B involved in the validation process 7 The validation process should include a sample set of at least 60 A cases for one application that reflects the spectrum and complexity of specimen types and diagnoses likely to be encountered during routine practice CAP Validation Recommendations
Recommendations Grade 8 The validation study should establish diagnostic concordance A between digital and glass slides for the same observer (i.e. intraobserver variability) 9 Digital and glass slides can be evaluated in random or nonrandom A order (as to which is examined first and second) during the validation process. 10 A washout period of at least 2 weeks should occur between B viewing digital and glass slides 11 The validation process should confirm that all of the material EC present on a glass slide to be scanned is included in the digital image 12 Documentation should be maintained recording the method, EC measurements, and final approval of validation for the WSI system to be used in the clinical laboratory CMS and CLIA CMS and CLIA CMS Form 116 (CLIA application form) REALITY! HYPE!! Adding Value to Surgical Pathology Generic Surg Path Workflow – with Imaging
Specimen TAKE A Accessioning Grossing triage PICTURE?
TAKE A Microtomy Embedding Processing PICTURE?
Staining Case SCAN/TAKE Microscopic coverslipping post-processing A PICTURE? analysis and archival & labeling Workflow and Time Considerations Got Scanners? Components of a WSI System...COST MONEY!!! DP - Storage as the Limiting Factor
GRAND TOTAL PER YEAR: ~2.3 PB Storage Costs are the Lowest Ever!
→ → →
Image from : https://community.spiceworks.com/topic/1993877-future-tech-storage-capacity-in-the-year-2030-and-beyond The Michigan Medicine Example - Costs Data Center Storage Costs
• – – – – – – – – Actual Storage Costs are MUCH MORE
→ Pathology Image Repository
Black box to your enterprise... Academic Clinical Imaging
Do you see Pathology? ANP Checklist - Image Retention Regulatory - Image Retention for Digital Images So...Keep Digital Pathology Images For How Long? Digital Pathology Has Great Potential for Data Integration
Illustration (modified) courtesy of Toby Cornish, MD To Add Value You MUST Understand Workflow
Key → CONTEXTUALLY-DRIVEN pathology processes!! Sign out Workflow: Current State Artificial Intelligence based systems should AUGMENT pathologist signout workflow!!
Sign out Workflow: Future State REALITY! HYPE?? Surgical Pathology Signout - 202X? Surgical Pathology Signout - 202X? Surgical Pathology Signout - 202X? QUESTIONS?