Real-world Data for Remote Sign-out

Dear Pathologists, Trainees, and Lab Professionals,

​​Although remote sign-out of pathology cases is not uncommon in certain parts of the world (i.e. Europe), it was not allowed in several countries (i.e. the US). In response to the national public health crisis, however, authorities from different countries have temporarily allowed pathologists to review pathology slides remotely**. In addition, some countries have released specific guidelines for the remote use of digital pathology systems. In the US this includes systems that have not been cleared***, meaning primary diagnoses can be rendered from a non-CLIA-licensed site if certain criteria are met. However, these policies are temporary, and will not permit remote sign out post-pandemic. 

The Digital Pathology Association (DPA)* continues to advocate for the emergency AND permanent use of remote sign-out. The DPA is proactively working with you, our DPA members, industry partners, and other entities, such as the College of American Pathologists (CAP) and the Alliance for Digital Pathology to help make a positive impact during this crisis and formulate a path forward.

One key DPA initiative is to gather real world data regarding remote sign-out for primary diagnosis and monitor/displays being used. This data collection will help the DPA and regulators better understand how remote sign out is being conducted and how to best support it moving forward. The overall goal is to:

 

  1. Collect data from pathologists using remote sign-out with whole slide images regarding scanners, operating systems, displays, etc. and evaluate if patient pathology specimens can be safely diagnosed remotely, while utilizing different scanners and displays
  2. Use this data to support policies that will allow remote sign out and increased interoperability
  3. Collect data to analyze if remote primary diagnosis can be safely performed and under what conditions
  4. Use such data to provide guidance and/or Quality Assurance metrics to users on how to best validate and support safe remote sign-out
  5. Show vendors what is needed, such as limitations in their technology to adequately support remote sign-out

 

To help us better prepare for this data collection project, we conducted a survey on remote sign-out. So, what’s in it for you? 

 

  • It will provide us with a holistic view and concrete data not so readily available today on the adoption of digital pathology on a global scale.
  • Real world data collected will exponentially help the field of pathology with implementing digital pathology, providing much needed information and guidance.
  • We will use your feedback to help the DPA and regulators understand how remote sign-out is being conducted to drive policies and standards; so, your expertise here matters.
  • Your participation will help the DPA work with regulatory agencies such as the FDA to discuss how to develop favorable and flexible guidance which could extend the remote use of digital pathology and artificial intelligence tools to help us weather this pandemic and better prepare for future disasters.
  • Most important, it will help your patients receive timely diagnoses, overall improving patient care, not only during this time of pandemic but as the new standard of practice for pathology moving forward.

 

We graciously thank those who responded. ​As a reminder, you will have access to the information as the DPA intends to publish the results. We have one common goal; to achieve better patient care and it is our hope that this data will help your institution determine how to best implement digital and computational pathology in your operations, including remote use.

Please feel free to contact us directly should you have any feedback, questions and/or concerns.

*The DPA is a nonprofit organization comprised of Pathologists, scientists, technologists, and industry representatives dedicated to advancing the field of digital pathology
**accessed April 24, 2020
http://www.clpmag.com/2020/03/digital-pathology-association-commends-cms-waiving-restrictions-remote-pathology-diagnoses/
https://www.usa.philips.com/healthcare/resources/landing/philips-intellisite-pathology-solution 
https://www.leicabiosystems.com/news-events/news-details/article/leica-biosystems-receives-fdas-enforcement-discretion-for-use-of-aperio-imagescope-dx-viewing-softw/News/detail/
​***accessed April 24, 2020:https://www.fda.gov/media/137307/download