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The DPA needs your help to assess the safety and validity of remote sign-out of pathology cases. If you are doing remote sign-out or plan to do it, please participate in the following brief survey. Your experience will help craft a response to the FDA and CMS that will promote the safe and effective use of this technology beyond the current pandemic. We appreciate your time and look forward to the productive engagement of all pathologists as well as laboratory and IT professional staff to provide critical real-world data. 

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* 1. What is your current role?

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* 2. Are you currently using Whole Slide Imaging Systems (WSI systems, i.e. scanner, workstation, including display) as well as image analysis algorithm at your primary workplace, i.e. your hospital, lab, reference lab?

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* 3. If yes, how many years have you been using WSI systems at your primary workplace?

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* 4. Prior to receiving this survey, were you aware of the emergency waiver from CMS and the FDA enforcement discretion allowing remote sign out of pathology cases during the COVID-19 Emergency?

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* 5. Are you currently (in last 2 months) remotely signing out cases by making use of the emergency waiver? (Please select all that apply)

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* 6. Please select yes or no regarding your use of the following digital pathology systems components.

  Currently using/installed at primary location Currently using/installed at remote location prior to COVID-19 Currently using/installed at remote location during COVID-19
Scanner(s)
Medical Grade Monitor(s)
Commercial Monitor(s)
Viewing Software
Image management software (workflow related, such as related to case load, case assignment)
Lab Information System (LIS)
Image Analysis software
Use a secure connection (VPN, IAM, PAM, etc.)

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* 7. Please identify which products (brand/model) you use for each of your pathology system components at your lab/hospital prior COVID-19.

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* 8. Did you require material or set-up changes to components of the Whole Slide Image System to enable remote use during COVID-19?

  Yes No
Scanner
Monitor
Viewing Software
VPN or Network Connection

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* 9. Please specify each component change and any impact this change has on your diagnostic decision making.

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* 10. Before the emergency waiver, what WSI use cases were you using at your institution in the last 6 months? (Please select all that apply)

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* 11. How many pathologists are signing out remotely/making use of the CMS emergency waiver? (Please select from the list below that best represents your number of Pathologists)

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* 12. Have you used any guideline/internal SOP to self-validate the remote use sign-out?

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* 13. If yes, is your institution willing to share its validation protocol and results?

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* 14. Has your institution included a quality assurance process such as retrospective review of a percentage of remotely signed out cases in the validation process?

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* 15. Did your your institution change procedure(s) to access the clinical patient information during remote use such as how you access or integrate with the electronic medical record or the laboratory information system?

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* 16. If regulations allowed, does your institution intend to continue to use remote sign-out following the COVID-19 pandemic?

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* 17. Have you experienced any issues with remote accessibility or maintaining QA during remote use? If yes, describe your experience.

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* 18. If you are interested in working with the DPA to collect real-world data on remote sign-out, please provide the following information. (Contact information is for internal use only and will not be shared.)

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