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Whole Slide Imaging and Telepathology

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Whole Slide Imaging

Abstract

Whole slide imaging (WSI) is a versatile technology with many applications in teaching, research, quality assurance, and clinical diagnostics. As a “store and forward” digital imaging technology, WSI is naturally suited to distribution over high-speed communication networks, which enables long-distance viewing of whole slide images originating at remote locations. For this reason, WSI is being applied to the practice of telepathology—literally “the study of disease at a distance.” Changes in the practice and business of medicine have been driving adoption of telepathology in recent years. Anyone looking to implement WSI telepathology needs to recognize and understand key aspects covered in this chapter. Technical considerations are key to creating usable telepathology networks. This includes understanding how network performance influences the function of WSI telepathology systems and how optimal deployment of hardware and software can help you meet your business needs and technical requirements. It is also important to recognize the advantages and disadvantages of WSI when compared to other telepathology modalities such as static image telepathology, dynamic telepathology, and robotic telepathology. In addition to technical considerations, practicing telepathology with WSI also raises regulatory and legal issues. These issues include specific features of in vitro device regulation, medical licensure, privileging and credentialing, and compliance with the Center for Medicare and Medicaid Services (CMS) and Clinical Laboratory Improvement Amendments (CLIA) regulations. Finally, laboratory accreditation requirements and issues with reimbursement for telepathology service are also discussed.

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References

  1. Jordan DS. The principles of sciosophy. Science. 1900;11(281):763–72.

    Article  CAS  Google Scholar 

  2. Weinstein RS. Prospects for telepathology. Hum Pathol. 1986;17(5):433–4.

    Article  CAS  Google Scholar 

  3. Lancet. Teaching by television. Lancet. 1951;258(6678):335–6.

    Article  Google Scholar 

  4. Allan R. Medical electronics: coming: the era of telemedicine: interactive audio/video telediagnosis is proven viable in both government- and privately-funded experiments. IEEE Spectr. 1976;13(12):31–6.

    Article  Google Scholar 

  5. Freehe CL. Video microscopy with closed circuit television at the University of Washington Health Sciences Division. J Biol Photogr Assoc. 1960;28:15–20.

    CAS  PubMed  Google Scholar 

  6. Murphy RL, Bird KT. Telediagnosis: a new community health resource. Observations on the feasibility of telediagnosis based on 1000 patient transactions. Am J Public Health. 1974;64(2):113–9.

    Article  Google Scholar 

  7. College of American Pathologists. Laboratory General Checklist. CAP Accreditation Program. College of American Pathologists; 2018.

    Google Scholar 

  8. Lin O, Rudomina D, Feratovic R, Sirintrapun SJ. Rapid on-site evaluation using telecytology: a major cancer center experience. Diagn Cytopathol. 2019;47(1):15–9.

    Article  Google Scholar 

  9. Centers for Medicare and Medicaid. Telehealth services [Internet]. Centers for Medicare and Medicaid. 2019 [cited 2019 Apr 4]. Available from: https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/Telehealth-Services-Text-Only.pdf.

  10. Centers for Medicare and Medicaid. Medicare carriers manual: section 15516, medicare payment for telehealth services [Internet]. 2003 [cited 2019 Jun 4]. Available from: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R1798B3.pdf.

  11. FDA, Office of the Commissioner. FDA allows marketing of first whole slide imaging system for digital pathology [Internet]. FDA. 2017 [cited 2019 Jun 4]. Available from: http://www.fda.gov/news-events/press-announcements/fda-allows-marketing-first-whole-slide-imaging-system-digital-pathology.

  12. Food and Drug Administration. 510(k) substantial equivalence determination decision summary: K172174 [Internet]. Food and Drug Administration. 2017 [cited 2019 Jun 4]. Available from: https://www.accessdata.fda.gov/cdrh_docs/reviews/K172174.pdf.

  13. Flory LE. The television microscope. Cold Spring Harb Symp Quant Biol. 1951;16:505–9.

    Article  CAS  Google Scholar 

  14. Light FW, Krigman MR. Microscopic telecommunication by closed-circuit television. Mil Med. 1967;132(1):28–33.

    Article  Google Scholar 

  15. Weaver JM, Frost JK, Nieburgs HE. Television microscopy in cytopathology [Internet]. Washington: U. S. Public Health Service, Division of Chronic Diseases, Cancer Control Program; 1965 [cited 2019 Jun 4]. 6 p. Available from: https://catalog.hathitrust.org/Record/009370018.

  16. Weinstein RS. Telemedicine: Back to the future - a 50 year perspective [Internet]. Northwest Regional Telehealth Resouce Center (NRTRC); 2015 Mar 30 [cited 2019 Jun 4]; Seattle, WA. Available from: https://www.nrtrc.org/content/presentation-files/Telemedicine%20Back%20to%20the%20Future%20-%20a%2050%20Year%20Perspective.pdf.

  17. Bashshur R. Technology serves the people: the story of a cooperative telemedicine project by NASA, the Indian Health Service and the Papago People. Indian Health Service, Staff Office of Planning, Evaluation and Research; 1979.

    Google Scholar 

  18. Freiburger G, Holcomb M, Piper D. The STARPAHC collection: part of an archive of the history of telemedicine. J Telemed Telecare. 2007;13(5):221–3.

    Article  Google Scholar 

  19. Riley FE. STARPAHC. Part 1: final summary report [Internet]. 1974 Jun [cited 2019 Jun 4]. Available from: https://ntrs.nasa.gov/search.jsp?R=19750007223.

  20. Viggiano LA. Diagnosis by satellite. Army Commun. 1986;11(1):54.

    Google Scholar 

  21. Weinstein R, Holcomb M, Krupinski E. Invention and early history of telepathology (1985–2000). J Pathol Inform. 2019;10(1):1.

    Article  CAS  Google Scholar 

  22. Weinstein RS. Telepathology diagnostic network [Internet]. US5216596A, 1993 [cited 2019 Jun 4]. Available from: https://patents.google.com/patent/US5216596A/en?q=weinstein&q=telepathology&oq=weinstein+telepathology.

  23. Nordrum I, Engum B, Rinde E, Finseth A, Ericsson H, Kearney M, et al. Remote frozen section service: a telepathology project in northern Norway. Hum Pathol. 1991;22(6):514–8.

    Article  CAS  Google Scholar 

  24. Ghosh A, Brown GT, Fontelo P. Telepathology at the Armed Forces Institute of Pathology: a retrospective review of consultations from 1996 to 1997. Arch Pathol Lab Med. 2018;142(2):248–52.

    Article  Google Scholar 

  25. Dunn BE, Choi H, Recla DL, Kerr SE, Wagenman BL. Robotic surgical telepathology between the Iron Mountain and Milwaukee Department of Veterans Affairs Medical Centers: a 12-year experience. Hum Pathol. 2009;40(8):1092–9.

    Article  Google Scholar 

  26. Kaplan KJ, Burgess JR, Sandberg GD, Myers CP, Bigott TR, Greenspan RB. Use of robotic telepathology for frozen-section diagnosis: a retrospective trial of a telepathology system for intraoperative consultation. Mod Pathol. 2002;15(11):1197.

    Article  Google Scholar 

  27. Evans AJ, Chetty R, Clarke BA, Croul S, Ghazarian DM, Kiehl T-R, et al. Primary frozen section diagnosis by robotic microscopy and virtual slide telepathology: the University Health Network experience. Hum Pathol. 2009;40(8):1070–81.

    Article  Google Scholar 

  28. Pantanowitz L, Parwani A, Wiley C, Ahmed I, Cable W, Contis L, et al. Experience with multimodality telepathology at the University of Pittsburgh Medical Center. J Pathol Inform. 2012;3(1):45.

    Article  Google Scholar 

  29. Bacus JW. jamesbacus.com BLISS system [Internet]. [cited 2019 Jun 4]. Available from: http://www.jamesbacus.com/page10.html.

  30. Bacus JV, Bacus JW. Method and apparatus for creating a virtual microscope slide [Internet]. US6272235B1, 2001 [cited 2019 May 17]. Available from: https://patents.google.com/patent/US6272235B1/en.

  31. Bacus JV, Bacus JW. Method and apparatus for acquiring and reconstructing magnified specimen images from a computer-controlled microscope [Internet]. US6101265A, 2000 [cited 2019 Jun 4]. Available from: https://patents.google.com/patent/US6101265A/en.

  32. Ferreira R, Moon B, Humphries J, Sussman A, Saltz J, Miller R, et al. The virtual microscope. Proc AMIA Annu Fall Symp. 1997:449–53.

    Google Scholar 

  33. Kayser K, Beyer M, Blum S, Kayser G. Recent developments and present status of telepathology. Anal Cell Pathol J Eur Soc Anal Cell Pathol. 2000;21(3–4):101–6.

    Article  CAS  Google Scholar 

  34. Wells CA, Sowter C. Telepathology: a diagnostic tool for the millennium? J Pathol. 2000;191(1):1–7.

    Article  CAS  Google Scholar 

  35. Jukić DM, Bifulco CB. Telepathology and pathology at distance: an overview. Croat Med J. 1999;40(3):421–4.

    PubMed  Google Scholar 

  36. Farahani N, Pantanowitz L. Overview of telepathology. Clin Lab Med. 2016;36(1):101–12.

    Article  Google Scholar 

  37. Bashshur RL, Krupinski EA, Weinstein RS, Dunn MR, Bashshur N. The empirical foundations of telepathology: evidence of feasibility and intermediate effects. Telemed E-Health. 2017;23(3):155–91.

    Article  Google Scholar 

  38. Bauer TW, Slaw RJ. Validating whole-slide imaging for consultation diagnoses in surgical pathology. Arch Pathol Lab Med. 2014;138(11):1459–65.

    Article  Google Scholar 

  39. Bauer TW, Schoenfield L, Slaw RJ, Yerian L, Sun Z, Henricks WH. Validation of whole slide imaging for primary diagnosis in surgical pathology. Arch Pathol Lab Med. 2013;137(4):518–24.

    Article  Google Scholar 

  40. Jones NC, Nazarian RM, Duncan LM, Kamionek M, Lauwers GY, Tambouret RH, et al. Interinstitutional whole slide imaging teleconsultation service development: assessment using internal training and clinical consultation cases. Arch Pathol Lab Med. 2015;139(5):627–35.

    Article  Google Scholar 

  41. Zhao C, Wu T, Ding X, Parwani A, Chen H, McHugh J, et al. International telepathology consultation: three years of experience between the University of Pittsburgh Medical Center and KingMed Diagnostics in China. J Pathol Inform. 2015;6(1):63.

    Article  Google Scholar 

  42. World Internet Users Statistics and 2019 World Population Stats [Internet]. [cited 2019 Jun 4]. Available from: https://www.internetworldstats.com/stats.htm.

  43. Farris AB, Cohen C, Rogers TE, Smith GH. Whole slide imaging for analytical anatomic pathology and telepathology: practical applications today, promises, and perils. Arch Pathol Lab Med. 2017;141(4):542–50.

    Article  CAS  Google Scholar 

  44. Fontelo P, Liu F, Yagi Y. Evaluation of a smartphone for telepathology: lessons learned. J Pathol Inform. 2015;6(1):35.

    Article  Google Scholar 

  45. Monaco SE, Koah AE, Xing J, Ahmed I, Cuda J, Cunningham J, et al. Telecytology implementation: deployment of telecytology for rapid on-site evaluations at an Academic Medical Center. Diagn Cytopathol. 2019;47(3):206–13.

    Article  Google Scholar 

  46. Michel R. Pathologists in China, U.S. linked by digital pathology [Internet]. The Dark Intelligence Group. 2012 [cited 2019 Jun 4]. Available from: https://www.darkintelligencegroup.com/the-dark-report/digital-pathology/pathologists-in-china-u-s-linked-by-digital-pathology/.

  47. UCLA Health International Telepathology Brochure [Internet]. UCLA Health. 2016 [cited 2019 Jun 4]. Available from: http://pathology.ucla.edu/workfiles/Clinical%20Services/Telepathology/EnglishBrochure11-23.pdf.

  48. Chlipala E, Elin J, Eichhorn O, Krishnamurti M, Long RE, Sabata B. Archival and retrieval in digital pathology systems [Internet]. Digital Pathology Association. 2011 [cited 2019 Jul 10]. Available from: https://digitalpathologyassociation.org/_data/files/Archival_and_Retrieval_in_Digital_Pathology_Systems.pdf.

  49. Miller K. Calculating optical fiber latency [Internet]. [cited 2019 Jun 4]. Available from: http://www.m2optics.com/blog/bid/70587/Calculating-Optical-Fiber-Latency.

  50. Frumento E. Cybersecurity and the evolutions of healthcare: challenges and threats behind its evolution [Internet]. springerprofessional.de. [cited 2019 Jul 10]. Available from: https://www.springerprofessional.de/en/cybersecurity-and-the-evolutions-of-healthcare-challenges-and-th/16506760.

  51. FDA Product Classification, Whole slide imaging system [Internet]. [cited 2019 Jun 11]. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=5048.

  52. Administration AGD of HTG. IVD medical devices: Definitions & links [Internet]. Therapeutic Goods Administration (TGA). 2010 [cited 2019 Jun 9]. Available from: https://www.tga.gov.au/ivd-medical-devices-definitions-links.

  53. Buckman Company v. Plaintiffs’ Legal Committee - Amicus (Merits) [Internet]. 2014 [cited 2019 Jun 11]. Available from: https://www.justice.gov/osg/brief/buckman-company-v-plaintiffs-legal-committee-amicus-merits.

  54. Canada H. Health Canada [Internet]. aem. 2019 [cited 2019 Jun 9]. Available from: https://www.canada.ca/en/health-canada.html.

  55. Abels E, Pantanowitz L. Current state of the regulatory trajectory for whole slide imaging devices in the USA. J Pathol Inform [Internet]. 2017 May 15 [cited 2019 Jun 9];8. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5450449/.

  56. Mukhopadhyay S, Feldman MD, Abels E, Ashfaq R, Beltaifa S, Cacciabeve NG, et al. Whole slide imaging versus microscopy for primary diagnosis in surgical pathology. Am J Surg Pathol. 2018;42(1):39–52.

    Article  Google Scholar 

  57. Borowsky AD, Glassy EF, Wallace WD, Kallichanda NS, Behling CA, Miller DV, et al. Digital whole slide imaging compared with light microscopy for primary diagnosis in surgical pathology: a multicenter, double-blinded, randomized study of 2045 cases. Arch Pathol Lab Med. 2020;arpa.2019-0569-OA.

    Google Scholar 

  58. College of American Pathologists. All common checklist. CAP Accreditation Program. College of American Pathologists; 2018.

    Google Scholar 

  59. Food and Drug Administration. Product classification: Digital Pathology Display (PZZ) [Internet]. [cited 2020 Apr 27]. Available from: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?id=5105.

  60. Leica Biosystems Receives FDA 510(k) clearance to market a digital pathology system for primary diagnosis [Internet]. Leica Biosystems. [cited 2019 Jun 9]. Available from: https://www.leicabiosystems.com/news-events/news-details/article/leica-biosystems-receives-fda-510k-clearance-to-market-a-digital-pathology-system-for-primary-diag/News/detail/.

  61. Food and Drug Administration. 510(k) substantial equivalence determination decision summary: K190332 [Internet]. Food and Drug Administration. 2019 [cited 2019 Jun 4]. Available from: https://www.accessdata.fda.gov/cdrh_docs/reviews/K190332.pdf.

  62. Food and Drug Administration. 510(k) substantial equivalence determination decision summary: K193054 [Internet]. Food and Drug Administration. 2020 [cited 2020 Apr 27]. Available from: https://www.accessdata.fda.gov/cdrh_docs/reviews/K193054.pdf.

  63. College of American Pathologists. Laboratory General Checklist. CAP Accreditation Program. College of American Pathologists; 2007.

    Google Scholar 

  64. Carlson DA. Laboratory inspections: the view from CAP. Lab Med. 2003;34(5):373–80.

    Article  Google Scholar 

  65. Clinical Laboratory Improvement Amendments (CLIA) Application For Certification. Form CMS-116. [Internet]. Centers for medicare and medicaid services. 2017 [cited 2019 Jul 5]. Available from: https://www.cms.gov/Medicare/CMS-Forms/CMS-Forms/downloads/cms116.pdf.

  66. College of American Pathologists. Validating Whole Slide Imaging for Diagnostic Purposes in Pathology. [cited 2021 Sep 21]. Available from: https://www.cap.org/protocols-and-guidelines/cap-guidelines/current-cap-guidelines/validating-whole-slide-imaging-for-diagnostic-purposes-in-pathology.

  67. Pantanowitz L, Hassell L, Henricks W, Lennerz J, Lowe A, Parwani A, et al. American telemedicine association clinical guidelines for telepathology. J Pathol Inform. 2014;5(1):39.

    Article  Google Scholar 

  68. College of American Pathologists. Anatomic pathology checklist. CAP Accreditation Program. College of American Pathologists; 2021.

    Google Scholar 

  69. Cornish TC, McClintock DS. Medicolegal and regulatory aspects of whole slide imaging-based telepathology. Diagn Histopathol. 2014;20(12):475–81.

    Article  Google Scholar 

  70. FSMB | Contact a State Medical Board [Internet]. [cited 2019 Jun 13]. Available from: https://www.fsmb.org/contact-a-state-medical-board/.

  71. Biereg J. Mr. Smith goes to Washington [Internet]. CAP Today Online. 2011 [cited 2019 Jun 13]. Available from: http://www.captodayonline.com/Archives/0311/0311d_mr_smith.html.

  72. Hiemenz MC, Leung ST, Park JY. Crossing boundaries: a comprehensive survey of medical licensing laws and guidelines regulating the interstate practice of pathology. Am J Surg Pathol. 2014;38(3):e1–5.

    Article  Google Scholar 

  73. Interstate Medical Licensure Compact | A faster pathway to medical licensure [Internet]. [cited 2019 Jun 4]. Available from: https://imlcc.org/.

  74. Hamilton TE. Telemedicine services in hospitals and critical access hospitals (CAHs) [Internet]. Centers for Medicare and Medicaid. 2011 [cited 2018 Oct 6]. Available from: https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter11_32.pdf.

  75. Wu Y-C, Chen C-S, Chan Y-J. The outbreak of COVID-19: an overview. J Chin Med Assoc. 2020;83(3):217–20.

    Article  CAS  Google Scholar 

  76. Azar AM. Determination that a public health emergency exists [Internet]. Depertment of Health and Human Services. 2020 [cited 2020 May 9]. Available from: https://www.phe.gov/emergency/news/healthactions/phe/Pages/2019-nCoV.aspx.

  77. Trump DJ. Proclamation on declaring a national emergency concerning the novel coronavirus disease (COVID-19) outbreak [Internet]. 2020 [cited 2020 May 9]. Available from: https://www.whitehouse.gov/presidential-actions/proclamation-declaring-national-emergency-concerning-novel-coronavirus-disease-covid-19-outbreak/.

  78. Kates J, Michaud J, Tolbert J. Stay-At-Home Orders to Fight COVID-19 in the United States: The risks of a scattershot approach | The Henry J. Kaiser Family Foundation [Internet]. 2020 [cited 2020 May 9]. Available from: https://www.kff.org/coronavirus-policy-watch/stay-at-home-orders-to-fight-covid19/.

  79. CDC. Coronavirus Disease 2019 (COVID-19): Older adults [Internet]. Centers for Disease Control and Prevention. 2020 [cited 2020 May 9]. Available from: https://www.cdc.gov/coronavirus/2019-ncov/need-extra-precautions/older-adults.html.

  80. Ehrlich H, McKenney M, Elkbuli A. Protecting our healthcare workers during the COVID-19 pandemic. Am J Emerg Med. 2020;S0735675720302527.

    Google Scholar 

  81. Robboy SJ, Weintraub S, Horvath AE, Jensen BW, Alexander CB, Fody EP, et al. Pathologist workforce in the United States: I. development of a predictive model to examine factors influencing supply. Arch Pathol Lab Med. 2013;137(12):1723–32.

    Article  Google Scholar 

  82. Metter DM, Colgan TJ, Leung ST, Timmons CF, Park JY. Trends in the US and Canadian pathologist workforces from 2007 to 2017. JAMA Netw Open. 2019;2(5):e194337.

    Article  Google Scholar 

  83. Alliance for Digital Pathology. CMS/CLIA allowing temporary remote signout [Internet]. [cited 2020 May 9]. Available from: https://digitalpathologyalliance.org/remote-signout.

  84. Centers for Medicare & Medicaid Services. Clinical Laboratory Improvement Amendments (CLIA) laboratory guidance during COVID-19 public health emergency; Memo No. QSO-20-21-CLIA [Internet]. 2020 [cited 2020 May 5]. Available from: https://www.cms.gov/files/document/qso-20-21-clia.pdf-0.

  85. Food and Drug Administration. Enforcement policy for remote digital pathology devices during the coronavirus disease 2019 (COVID-19) public health emergency - guidance for Industry, Clinical Laboratories, Healthcare Facilities, Pathologists, and Food and Drug Administration Staff [Internet]. 2020 [cited 2020 May 5]. Available from: https://www.fda.gov/media/137307/download.

  86. Technical performance assessment of digital pathology whole slide imaging devices - guidance for Industry and Food and Drug Administration Staff [Internet]. April 2016 [cited 2019 Jun 13]. Available from: https://www.fda.gov/media/90791/download.

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Cornish, T.C., McClintock, D.S. (2022). Whole Slide Imaging and Telepathology. In: Parwani, A.V. (eds) Whole Slide Imaging. Springer, Cham. https://doi.org/10.1007/978-3-030-83332-9_7

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