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Validation of a digital pathology system including remote review during the COVID-19 pandemic
Matthew G Hanna1, Victor E Reuter2,3, Orly Ardon2
1Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, NY, 10065, USA. hannam@mskcc.org.
Insights
Remote digital pathology enables secure, accurate cancer diagnosis during public health emergencies. This study validated remote review of pathology slides, achieving 100% diagnostic concordance, ensuring patient care continuity.
Area of Science:
- Medical diagnostics
- Digital pathology
- Oncology
Background:
- Public health emergencies, such as the COVID-19 pandemic, necessitate remote healthcare operations.
- Existing Clinical Laboratory Improvement Amendments (CLIA) regulations mandate in-person verification of pathology reports from certified facilities.
- Remote pathology review poses risks of infection transmission to pathologists and their families.
Purpose of the Study:
- To validate the diagnostic accuracy and operational feasibility of remote pathology slide review and reporting.
- To assess the concordance between remote digital diagnosis and traditional glass slide microscopy.
- To evaluate the performance and usability of digital pathology systems for remote sign-out.
Main Methods:
- Surgical pathology slides from routine clinical workload were scanned at high resolution.
- Twelve pathologists remotely reviewed and reported complete cases using a digital pathology system via a secure connection.
- Intraobserver concordance was assessed by comparing remote digital diagnoses with subsequent in-person glass slide reviews.
Main Results:
- Major diagnostic equivalency between digital and glass slide diagnoses was 100%.
- Overall concordance between remote digital and in-person glass slide diagnoses was 98.8% (251/254 cases).
- High intraobserver concordance (100%) was achieved for major diagnoses when reporting remotely.
Conclusions:
- Remote digital pathology systems are operationally feasible for reviewing and reporting pathology specimens.
- This study successfully validated remote pathology diagnosis, demonstrating high accuracy and concordance.
- Remote pathology review ensures continuity of patient care during public health emergencies while minimizing infection risks.
Abstract:
Remote digital pathology allows healthcare systems to maintain pathology operations during public health emergencies. Existing Clinical Laboratory Improvement Amendments regulations require pathologists to electronically verify patient reports from a certified facility. During the 2019 pandemic of COVID-19 disease, caused by the SAR-CoV-2 virus, this requirement potentially exposes pathologists, their colleagues, and household members to the risk of becoming infected. Relaxation of government enforcement of this regulation allows pathologists to review and report pathology specimens from a remote, non-CLIA certified facility. The availability of digital pathology systems can facilitate remote microscopic diagnosis, although formal comprehensive (case-based) validation of remote digital diagnosis has not been reported. All glass slides representing routine clinical signout workload in surgical pathology subspecialties at Memorial Sloan Kettering Cancer Center were scanned on an Aperio GT450 at ×40 equivalent resolution (0.26 µm/pixel). Twelve pathologists from nine surgical pathology subspecialties remotely reviewed and reported complete pathology cases using a digital pathology system from a non-CLIA certified facility through a secure connection. Whole slide images were integrated to and launched within the laboratory information system to a custom vendor-agnostic, whole slide image viewer. Remote signouts utilized consumer-grade computers and monitors (monitor size, 13.3-42 in.; resolution, 1280 × 800-3840 × 2160 pixels) connecting to an institution clinical workstation via secure virtual private network. Pathologists subsequently reviewed all corresponding glass slides using a light microscope within the CLIA-certified department. Intraobserver concordance metrics included reporting elements of top-line diagnosis, margin status, lymphovascular and/or perineural invasion, pathology stage, and ancillary testing. The median whole slide image file size was 1.3 GB; scan time/slide averaged 90 s; and scanned tissue area averaged 612 mm2. Signout sessions included a total of 108 cases, comprised of 254 individual parts and 1196 slides. Major diagnostic equivalency was 100% between digital and glass slide diagnoses; and overall concordance was 98.8% (251/254). This study reports validation of primary diagnostic review and reporting of complete pathology cases from a remote site during a public health emergency. Our experience shows high (100%) intraobserver digital to glass slide major diagnostic concordance when reporting from a remote site. This randomized, prospective study successfully validated remote use of a digital pathology system including operational feasibility supporting remote review and reporting of pathology specimens, and evaluation of remote access performance and usability for remote signout.
