Twitter Chat Summary

Pajamas & Pathology: Implementing Remote Sign-out 

Moderator:
Adam L. Booth, MD; University of Texas Medical Branch

Panelists:
Marilyn Bui, MD, PhD; Moffitt Cancer Center
Eric Glassy, MD; Affiliated Pathologists Medical Group
Liron Pantanowitz, MD; University of Pittsburgh Medical Center
Anil Parwani, MD, PhD; The Ohio State University

Q1. What does the relaxed CMS waiver mean to pathologists?

A1. It means we can sign out from home, at least for now – Dr. Pantanowitz

A1. Waiver allows pathologists to sign-out path cases from a non-CLIA licensed facility (e.g. home office) as long as the primary facility has such a license. It covers primary diagnosis, NGS, flow cytometry, electrophoresis, etc. – Dr. Glassy

A1. Unknown for now if we can continue. Important to get data to show equivalency between scope and digital. FDA wants data. We can prove our point and show the value. – Dr. Glassy

A1. Challenges are most IT related and security. Must keep HiPAA in mind. Patient info on kitchen table is not OK. – Dr. Glassy

Q2. Can I sign out from my home using digital pathology for primary diagnosis?

A2. Yes, you can SIGN-OUT from home if validation is done – Dr. Parwani

A2. Yes, but it is important that the system be validated, you are properly trained, and HIPAA issues respected. – Dr. Glassy

A2. Approved equipment is what you validate, no need for FDA-blessed system. You do NOT need an FDA-approved system to do this. I know people doing live video for cytology reads remotely. Not FDA approved. Validation is the key. I like Liron’s approach. Do a validation from home (CAP guidelines) then replicate and verify at other similar remote sites. No need to have every pathologist do full validation. – Dr. Glassy

Q3. Is it okay to use my home laptop or monitor for remote sign-out?

A3. Yes. But validation is needed to show the personal devices are no inferior that the office computer – Dr. Bui  

A3. Here is a great tool from Leeds to check the quality of monitor/laptop for remote sign out – Dr. Pantanowitz

Q4. Does my lab have to use an FDA approved whole slide imaging system? 

A4. Not necessarily. You can use a non-FDA system as long it is validated – Dr. Parwani  

A4: The FDA approved system needs less stringent validation process, but non-FDA system can be used as LDT need a more stringent validation. – Dr. Bui

Q5. What does my lab need to do to validate remote sign out using WSI?

A5. When we return back to normal (hopefully soon) and many folks did not use FDA-cleared systems, but it worked. What then?? – Dr. Pantanowitz

A5. As more pathologists signout remotely, we will have more data and evidence about safety and value. You need a digital pathology system which is validated for onsite and then extend this validation to remote signout – Dr. Parwani  

A5. 60 for each major use case, 20 for similar ones – Dr. Glassy

   A. Agree. Recipe = 60 H&Es + 20 histochemical stains + 20 IHCs (glass vs digital with >2week washout) – Dr. Pantanowitz

A5. Yes. – Dr. Bui

Q. Is it possible to continue CMS waiver for signing out from home even after the lockdown?

A. We hope so. Maybe this will change people's minds (pathologists & regulators)

A. I've heard from pathologists signing out remotely in the US, Italy & Europe due to the COVID pandemic

Q. What challenges have people faced who are doing this as a new thing now (not a planned event per se)?

A. Issues include internal approvals & some IT factors (viewers, Mac vs PC compatibility, bandwidth) – Dr. Pantanowitz

A. Some institutions are ahead of the game because they have validated using whole slide imaging for primary diagnosis before covid19. They now can validate the remote sign out component so that their pathologists can work from home – Dr. Bui

Q. What is the approved equipment in terms of scanner etc.?

A. You can use FDA approved scanners and workflow or use hardware which is validated by your labs. – Dr. Parwani

Q. We also validated remote sign out at UPMC per CAP guidelines, BUT how do you do sign-off on pathologist competency?

A. You have to use the QA processes that you use for glass slide workflow; adequate trading is also needed – Dr. Parwani

Q. How long does it take to validate a system? Do we need to validate for all biopsy types?

A. It's not hard to validate at all. Just follow these easy CAP guidelinesDr. Pantanowitz

A. Once validated for your lab, additional validation can help you to setup remote sign-out – Dr. Parwani

Q. What about changes in workflow? Do people need to stagger their schedules more? Move staff to scanning duty if more remote Signout is being performed?

A2. Validate for your use case. Primary dx of 60 cases with the range normally seen. If GI doc doing it, most GI, etc. 2-week washout but with COVID, just pull 60 old cases, scan them and then compare digital and glass. – Dr. Glassy  

A. Using digital pathology will change workflow for sure. IT, scanning technologists and high-volume scanners are some of the basic investment – Dr. Bui

Q. Does each non-CLIA licensed facility need to undergo a validation process?

A. Patient safety and quality of our work is critically import. The primary lab must be CLIA certified. The associated/extension facility does not need it during the waiver period but need validation for quality and safety purpose. – Dr. Bui  

Q. How long does it take to validate a system? Do we need to validate for all biopsy types?

A. Please check out the CAP web site for remote sign out FAQs and the reference. If the lab has already down a validation for primary diagnosis before, the validation for remote sign out can be a more accelerated process. – Dr. Bui

Q. Does the review apply only to Whole Slide Images or can you also use various algorithms?

A. Yes, algorithms too as long as they are validated – Dr. Parwani  

A. My understanding is that it applies to anything (WSIs, Flow, NGS, even CTs screening Paps from home!) – Dr. Pantanowitz   

Q. Is there guidance around validating algorithms? I'm familiar with 60 cases for WSI but not around algorthms.

A. Yes, ok as long as you validate it. – Dr. Parwani  

A. Yes, the CAP published QIA guidelines for HER2 that can be extrapolated. – Dr. Pantanowitz

A. If remote access to the work computer which was already validated to do quantitative image analysis by algorithm, it would be similar “another application” which means 20 cases is sufficient, right? – Dr Bui

Q. Do you also do ROSE remotely? Or sign out cytology remotely?

A. Yes ROSE, frozen etc but not cytology yet – Dr. Parwani  

A. Yep, at UPMC we have enabled telecytology for ROSE from home and it is working well – Dr. Pantanowitz

A. Talked to Rose Wu at Penn who is doing ROSE remotely and also virtually teaching her cytoplasms fellow. – Dr. Glassy

A. Some pathologists do ROSE using digital pathology in their hospitals. I have not heard anyone doing it from home yet. Again, this can be done as long as the validation and a process is in place to ensure the patient safety and the quality of diagnosis. – Dr. Bui

A. Not sure WSI would be best solution for ROSE. Live video seems the better option. – Dr. Glassy

    A. Agree...live stream or robotic microscopes are better – Dr. Parwani  

    A. We do live HD video streaming (if a CT is onsite) or robotic telemicroscopy (if there is no CT onsite) – Dr. Pantanowitz  

Q. Are there any resources/recommendations for validation for remote sign-out?

A. Yes, go to https://www.cap.org/covid-19/remote-sign-out-faqsDr. Pantanowitz

A. Digital slides and remote SIGN-OUT have helped us tremendously during this difficult time to maintain social distance – Dr. Parwani 

Q. Has anyone had CT's do remote sign-out from home? If not, would you be willing to? What concerns would you have? 

A. Not yet. Volumes for some cytology cases (Paps, urines) have dropped so there is less pressure to do this now. There are lots of tools to "dot" slides (e.g. annotation). Check out this example: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3870328/Dr. Pantanowitz  

Q. How do you define a discordance?

A. If the alternative method cannot give the same diagnostic result in 90% of the cases exams, it is discordance – Dr. Bui  

Q. How to validate remote signout?

A. At our institute we are doing additional 20 case review per pathologist plus training and monitor verifications – Dr. Parwani  

Q. Are there any resources/recommendations for validation for remote signout?

A. DPA is working on this. There is a real need of this for DPA membership and beyound. Thank you for motivating us to work harder – Dr. Bui

Q. Any key takeaways?

A. I do remote signouts with residents. They preview digital cases and we share my screen and discuss cases…social distancing – Dr. Parwani

A. If we didn't get to answer all your questions join the DPA for more answers - we're here for you digitalpathologyassociation.org/membershipDr. Pantanowitz  

A. The burning platform such as #covid19 makes us have to make the jump to accelerate the adoption of whole slide image for primary diagnosis. DPA is working hard to move the field forward so that pathologists can do the important work for patients – Dr. Bui