RFI Engagement Questions.docx

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6515--RFI Remote Patient Pedal Monitoring
Solicitation number
36C79125Q0022
Issued by

About this file

This document is a Request for Information (RFI) from the Department of Veterans Affairs (VA) seeking industry feedback on a proposed Remote Pedal Monitoring Program for Veterans. The RFI contains 15 detailed engagement questions designed to assess vendor capabilities for developing and deploying a thermal imaging-based remote pedal monitoring device for up to 100,000 Veterans nationwide. Key technical requirements include FDA clearance, integration via HL7 FHIR and REST-based APIs, encrypted data transfer meeting FIPS 140-2 Level 2 standards, clinical monitoring services, patient onboarding within 3-5 business days, and compliance with Section 508 accessibility requirements.

The RFI is part of a market research effort to improve understanding of industry capabilities for this new VA program, with a focus on commercial best practices, innovative delivery approaches, and performance strategies. The solicitation (Number 36C79125Q0022) is classified under NAICS code 621999 and PSC code 6515, targeting miscellaneous ambulatory health care services. Importantly, this RFI is solely for market research purposes, does not constitute a formal procurement, and does not guarantee future business opportunities for participating vendors. Responses should be submitted to eric.asper@va.gov and andrea.torrano@va.gov, with vendors encouraged to mark any proprietary information accordingly.

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File Type Posted
SOP_TMD_5_26_2022.pdf PDF
RPPM - PWS DRAFT RFI.docx DOCX document
36C79125Q0022.docx DOCX document
RPPM - Milestones DRAFT.pdf PDF

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Request for Information (RFI) Engagement Questions Attachment General Capability and Product Alignment

1.Does your company currently provide a thermal imaging-based remote pedal monitoring device designed for daily in-home use?
2.Does your device meet the minimum technical specifications outlined in Section 3.3.1 of the draft PWS? If not, what modifications would be required to comply?

Scalability and Distribution

3. Can your company scale delivery and support for up to 100,000 Veterans nationwide, as outlined in Section 1.1? If not, what are the limitations and proposed phasing strategies?

Integration and Data Handling

4.Does your system currently support integration via HL7® FHIR® and REST-based APIs as described in Section 3.2? If not, how long would development take to meet this requirement?
5.Do you currently have a secure method for encrypted data transfer to external systems (such as VA EHR systems) that meets FIPS 140-2 Level 2 or higher?

Clinical and Monitoring Services

6.Do you offer clinical monitoring and patient outreach services in alignment with the requirements of Section 3.3.3?
7.Are your support staff trained in patient engagement, education, and wellness check protocols?

FDA, TAA, and Other Compliance

8.Is your product FDA cleared under 510(k)?
9.Are all offered products Trade Agreements Act (TAA) compliant?

Training and Customer Support

10.Does your company provide patient onboarding and training via telephone within the required 3-5 business day timeframe?
11.Can your company support the VA’s language and Section 508 requirements for training materials?

Pricing Feedback (Optional)

12.What are the primary cost drivers you foresee with the scope outlined in the PWS?
13.Do you foresee challenges with a General Service Fee (GSF) model on a per-patient-per-month basis?

Solicitation Readiness

14.Does any part of the PWS present barriers to your company’s ability or interest in competing? Please explain.
15.What clarifications or additional information would improve your ability to respond to a future solicitation?

Vendors are encouraged to review the attached Draft PWS in detail and respond to the questions provided above. Responses may include comments, capability statements, suggested changes to the PWS, and feedback on technical feasibility, pricing structures, and performance risks. Vendors may also submit questions or request clarification on any part of the Draft PWS requirement.

File details come from the government source that posted it. Updated .