6515--Remote Patient Monitoring - Home Telehealth (RPM-HT) FY 2022
Request for Information (RFI) Remote Patient Monitoring - Home Telehealth (RPM-HT) 7-9-2020 DISCLAIMER This Request for Information (RFI) is issued solely for market research and planning purposes onl... Request for Information (RFI) Remote Patient Monitoring - Home Telehealth (RPM-HT) 7-9-2020 DISCLAIMER This Request for Information (RFI) is issued solely for market research and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. In accordance with FAR 15.201(e), responses to this notice are not offers and cannot be accepted by the Government/Department of Veterans Affairs (VA) (VA and Government may be used interchangeably) to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Please see the Statement of Work (SOW) for definitions and additional information. Any references to Attachments within the SOW are not provided for the purposes of the RFI. Request for Information Remote Patient Monitoring - Home Telehealth (RPM-HT) 7-9-2020 Title: Sources Sought notice for products and services to support the Department of Veterans Affairs enterprise-wide Remote Patient Monitoring - Home Telehealth (RPM-HT). The purpose of this RFI is to conduct market research to support an upcoming procurement and to update/refine the SOW to incorporate new commercial technologies and capabilities to better support the RPM-HT Program. This RFI encourages potential contractors to submit a capabilities statement and responses to the questions within this RFI. A spreadsheet is provided to track your company s responses to the questions herein. Please ensure your responses correlate to the letter/number format of this RFI, when possible. Please submit your company s capabilities statement (no longer than 3 pages) and completed vendor response spreadsheet electronically to Ms. Alyssa Urquhart at Alyssa.Urquhart@va.gov AND Mr. Joseph Kohles at joseph.kohles@va.gov no later than August 10, 2020 at 3:00 p.m. Mountain Daylight Time (MDT). Please include your company name in the subject of the email response as: "Attention: RPM-HT RFI VENDOR NAME HERE". Requirements Summary: All items that are specified by the VA in this RFI must be commercially available as telehealth/disease management products. The VA seeks contractors to provide Medical Device Data System (MDDS) platforms for use by Veterans together with the requisite data management, support services and information technology services necessary to provide a comprehensive range of RPM-HT services. These MDDS platforms are used for data access and communication. The link Veteran patients receiving RPM-HT based care with Veterans Health Administration (VHA) clinicians using a range of telecommunications system options. These platforms and associated systems must support and enable bi-directional transfer of prescribed data, as outlined below from Veteran patients to VHA and vice versa. VA is seeking technologies (mobile and stationary defined in the SOW) that collect and securely transmit encrypted patient data through various disease management protocols (DMPs) either via VA provided platforms/devices or Veteran owned devices. The VA contracting office is requesting responses from qualified business concerns; the qualifying NAICS code for this effort is 621999 All other Miscellaneous Ambulatory Health Care Services . The broad requirements listed below should be reviewed in order to accurately respond to this notice. The Government is also seeking to gain knowledge of potential qualified sources and their size classifications, Service Disabled/Veteran Owned Small Business (SDVOSB/VOSB), HUBZone Program, 8(a), Small Business (SB), Small Disadvantaged Business, Woman Owned Small Business, or large business (LB) status; relative to NAICS 621999. Preliminary Review of Product Information: Responses to this notice will be used by the Government to make appropriate acquisition decisions. After review of the responses to this notice, a request for proposals may be issued to the government wide point of entry (www.beta.sam.gov). Responses to this RFI are not considered adequate responses to any corresponding solicitation announcement. Background: The mission of the VA/VHA is to provide benefits and services to Veterans of the United States. VHA has made a considerable investment organizationally as well as in medical technologies to support digital health technology capabilities. The Office of Connected Care (OCC) Telehealth Services Program uses telehealth technologies to provide clinical care in circumstances where distance separates those receiving services and those providing services. The value VHA derives from Telehealth is not just in implementing telehealth technologies alone, but incorporates how VHA utilizes health informatics, disease management, self-management, and care/case management to facilitate access to care and improve the health of Veterans with the intent to provide the right care in the right place at the right time. Please see SOW for more background details. Corporate information 1. Provide your company s contact information (Company name, address, Point of contact name and email). 2. Indicate whether your business is a Small Business (SB) or Large Business (LB). If small, indicate if your firm qualifies as a small, emerging business, or small disadvantaged business. If disadvantaged, specify the disadvantaged group. 3. Specify if your firm is certified under Section 8(a) of the Small Business Act. Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business (SDVOSB) or Veteran Owned Small Business (VOSB). 4. Include the DUNS number of your firm. 5. State whether your firm is registered with the System for Award Management (SAM) at http://www.sam.gov and/or the VetBiz Registry at http://vip.vetbiz.gov. If not, please NOTE that any future solicitation could only be awarded to a contractor who is registered in SAM; in order to receive award based on VOSB or SDVOSB status you must be registered in the VetBiz Registry. 6. Provide product information including product specifications and pricing for supplies and services and whether or not they are commercially available and length of time they have been in use. F. Vendor Platform Capabilities (Please review definitions in the SOW for a description of each platform): Hub Does your company provide this platform? What challenges, if any, does your company face in providing a hub device? Specifically, challenges related to connectivity using cellular, POTS, and home Wi-Fi connections? Does your company manufacture its own device, or would the company be using a mobile device to fulfill this requirement? If so, who manufactures it? How are remote upgrades performed? Is screen sharing supported of the vendor dashboard between the VHA Care Coordinator and Veteran (educational materials, trending vital signs/graphs)? Does your company s device (manufactured or distributed) have the ability to deliver educational content or information through video technology to educate a patient about their clinical condition? Video Hub Does your company provide this platform? What challenges, if any, does your company face in providing a video hub device? Specifically, challenges related to connectivity using cellular, POTS, and home Wi-Fi connections? Does your company manufacture its own device, or would the company be using a tablet to fulfill this requirement? If so, who manufactures it? How are software remote upgrades performed? Is your technology flexible to meet integration with VA Video solution (e.g. Pexip®)? Describe the video portion of your company s video hub; how does the video hub differ from hub device? Can Care Coordinators and other healthcare providers view video via their VA desktop or only through a web viewer? Can your company s video hub capture and transmit biometric data in session? Do you have remote ability for a clinician to manually pan, tilt, and zoom video camera (i.e. to visualize environment, gait etc.)? Can the video camera detach from the base for mobile or hand-held use (i.e. to view skin and wounds, etc.)? Is screen sharing supported of the vendor dashboard between the VHA Care Coordinator and Veteran (educational materials, trending vital signs/graphs)? Does your company s device (manufactured or distributed) have the ability to deliver educational content or information through video technology to educate a patient about their clinical condition? Interactive Voice Response (IVR) Does your company provide this platform? What challenges, if any, does your company face in providing this IVR platform? What method would your company use to capture and transmit biometric data? Is it capable of Bluetooth® capture and transmission? VHA would like to see Bluetooth® Peripherals utilized with IVR in a way that meets all the program requirements (see SOW Section 5.8.1) for completing both a DMP session and vitals sign capture. This would ideally be done in a way that does not allow patient to ONLY complete vital signs, thereby skipping the DMP process. Does your company offer a solution that would address this capability? Mobile Device (e.g. laptop, tablet, smart phone) Does your company provide this platform? What challenges, if any, does your company face in providing this Mobile Device CLIN platform requirement? What method would your company use to capture and transmit biometric data? Is it capable of Bluetooth® capture and transmission? VHA would like to see Bluetooth® Peripherals utilized with Mobile Platforms in a way that meets all the program requirements for completing both a DMP session and vitals sign capture. This would ideally be done in a way that does not allow Veteran to ONLY complete vital signs, thereby skipping the DMP process. Does your company offer a solution that would address this capability? What challenges, if any, does your company face with purchasing Mobile Devices that are Trade Agreement Act (TAA) compliant? Does your company have end of life (EOL) issues with this technology? If so, how do you mitigate EOL issues? What challenges, if any, does your company face adding other VHA applications and links (e.g. PTSD Coach, MyHealtheVet), especially regarding the security of Veteran PII and PHI from your application and your Authority to Operate (ATO)? Does your company prefer providing its own Mobile Device solution, or utilizing VHA issued mobile devices that could incorporate your mobile application? Mobile Application Does your company provide this platform? Would your company prefer having its app available via your company s Mobile Device solution, or utilizing other VHA issued mobile device? What problems and/or challenges, if any, do you anticipate from utilizing your application on VHA issued and/or Veteran owned devices? Are there any obstacles in offering/downloading apps from any specific Mobile Device manufacturer (i.e. App Store via Apple, Google Play etc.)? Web Application Does your company provide this platform? What problems and/or challenges, if any, do you anticipate from utilizing your web application on VHA issued and/or Veteran owned devices? Would your mobile application (app) be any different than your web application (URL)? e.g. would you get the full site details and functionality on the app as you would from the URL on a computer? If not, please explain. Care Coordinator Web Viewer (CCWV) Does your company provide this platform? How would your CCWV meet processes to identify and flag any potentially inaccurate data, such as a weight that shifts 100 pounds in one day, as well as a method to remove and/or annotate inaccurate readings such that they can be reconciled and displayed correctly and do not adversely affect data averages/trending reports? 8. General questions/requests regarding all platforms: Include information of how data is transmitted from the patient assigned platform to the vendor server on each platform (telephone landline/Plain Old Telephone Service (POTS), cellular, satellite, broadband, Wi-Fi, etc.) Are any or all of your company s platforms programmed with readily available multi-modal transmission capabilities as standard issue? Include information on the capability of all platforms to be updated remotely for any software and/or firmware and without requiring any involvement from the Veteran or VHA staff. Describe any impact to the patient/Veteran receiving automated/remote upgrades, such as average length of downtime of RPM-HT platforms and/or utilization of Veteran s own telephone line during the upgrade process. For all platforms that may be offered on a possible Request for Proposal (RFP): Provide a full description and images to include functionalities and capabilities of your company s platforms. Prefer that documents are sent electronically as PDFs or please provide an URL link to access the information. Include information of how data is transmitted from the patient assigned platform to the vendor server on each platform (telephone landline/Plain Old Telephone Service (POTS), cellular, satellite, broadband, Wi-Fi, etc.) Are any or all of your company s platforms programmed with readily available multi-modal transmission capabilities as standard issue? Include information on the capability of all platforms to be updated remotely for any software and/or firmware and without requiring any involvement from the Veteran or VHA staff Describe any impact to the patient/Veteran receiving automated/remote upgrades, such as average length of downtime of RPM-HT platforms and/or utilization of Veteran s own telephone line during the upgrade process. 6) Describe any existing global messaging system capability that your company has in place that could be used to communicate issues such as outages and software updates and population health information to Veterans. 7) Address the ability or challenges to meet the following for global and/or individual messages: Maximum character length (e.g. supporting messages with over 250 characters) Veteran option to read and/or cancel/disable messages Delivery of global messages program wide, Veterans Integrated Service Networks (VISN) wide, facility wide or to a group of Veteran cohorts G. Peripheral Measurement Technologies for Required Platforms The following FDA approved peripheral measurement technologies (a through g) will likely be required for capture of vital sign measurements/biometric data, that interface with the MDDS platform. Describe/comment on your company s ability to provide the peripherals below and any distinguishing characteristics. Describe how the interface could/would occur (e.g. cable, Bluetooth® or self- reported) Digital Weight Scale Does the scale have talking ability and voice response? Describe the scales maximum weight capabilities. Does your company have a standing scale with handrails? Electronic Digital Blood Pressure Monitor with pulse measurement in a variety of different sizes of cuffs and/or wrist cuffs Non-pharmacy digital blood glucose meter cable and glucose meter adaptor (Bluetooth®) that would interface with VA provided blood glucose meters Electronic Thermometer (List options for method (e.g. ear, forehead, no touch, etc.)) Pulse Oximeter Can you transmit oxygen (O2 saturation without heart rate (to avoid discrepancies with BP monitor))? Spirometer Pedometer Do your company s peripheral measurement technologies have the capability to capture and transmit via all platforms by wired and/or wireless connections and self-reported/manual entry? Please describe each platform s capability. Are there any adjustment programming for Bluetooth® peripherals? VA is considering providing standard Bluetooth® (BT) and Bluetooth® enabled (BTE) FDA approved peripherals to improve efficiency and reduce cost. Our RPM-HT vendors would need to ensure their platforms are compatible with the following VA peripherals and that they transmit accurate values and date/time stamp. Provide any questions and/or concerns regarding a potential requirement to utilize VA standard peripherals. Peripherals and current models used within the VA are listed below (subject to technical refresh) Peripherals Current models as of July 2020 Blood Pressure device A&D UA-651 BLE Pulse Oximeter Nonin 3230 Bluetooth® Smart Stethoscope Eko DUO Stethoscope and EKG Thermometer FORA IR20b BLE Version 4 Weight scale A&D UC-352 BLE b) Provide comments regarding your ability to provide the following optional peripherals (or others not listed) on the vendor response spreadsheet: Electrocardiogram Otoscope Health and Fitness Tracker Coagulation Monitoring Device Continuous Blood Glucose Monitor interface Wearables (e.g. Smart watch) Hemoglobin A1c (at home) Other H. Disease Management Protocols (DMP s) In addition to DMP requirements listed in the SOW, VHA would like to add the following capabilities. Please describe if your company can do the following: The ability to add a 4th alert color to the DMP s and CCWV. In addition to the green, yellow, red alerts already in place and in the current SOW (Section 8.1.3), VHA would like to add another other designated color alert on the VHA DMP s for suicidal alerts. Would your company be able to support this? Ability to restrict DMP assignment options based on patient specific populations (e.g. Category of Care) Provide other vendor developed DMPs in addition to the required VHA DMPs Upgrade DMP content IAW SOW (see section 8) without resetting current Veteran-assigned DMP schedules Ability for VHA Care Coordinators to customize DMP s to patient specific needs/concerns I. Date-Time Stamp Describe how their platforms can be used with utmost confidence of date/time stamp accuracy. Accurate date/time stamp allows Care Coordinators to safely and efficiently manage large patient panel sizes using alert thresholds so that this data can be accurately documented in the patient s official electronic medical record. Vendors should describe how values and date/time stamps can be flagged based on VHA business rules for being potentially inaccurate. That flag would prevent direct entry into the electronic medical record system until validated and unflagged by the Care Coordinator. Describe how all platforms (hub device, IVR and web-enabled technology, etc.) assigned for patient use meet accurate date/time stamp requirements, including any peripheral measurement devices (blood pressure monitors, blood glucose meters, weight scales, pulse oximeters, etc.,) that would be used by the patient, regardless of the connection type for such peripheral measurement devices (integrated into RPM-HT platform, connected via cable, or have wireless transmission capability, entered manually by patient, etc.). Describe the processes your company uses for testing and verifying date/time stamp accuracy for all platforms and peripheral measurement devices that connect to a vendor s system. How often does your company verify/validate accurate date/time stamp? Describe how battery-operated peripheral measurement devices and devices with individual setting functions or with their own internal processors (e.g., blood glucose meters) are designed to reliably integrate with the RPM-HT platform (hub device, IVR and web-enabled technology, etc.) so that an accurate date/time stamp will be provided for each measurement taken, despite any additional programming functions that may be available or used by the patient on that peripheral measurement device. Describe how data collected prior to enrollment and stored in a peripheral measurement device would not be transmitted or would be flagged as pre-enrollment data in the CCWV. What is your ability to identify, in the CCWV, potentially inaccurate date time stamp or values? J. Clinical Data Reporting: In addition to meeting the reporting requirements in the SOW (see section 9), below are some examples of additional identified needs. Please provide a description of your company s ability to meet these reporting needs: Patient facing data and/or graphs of trends Blood glucose reports/log that include items such as fasting vs non fasting, and notation regarding mealtimes Vendor CCWV response reporting to be consistent with required VA response reporting per SOW (see section 9) List/describe other clinical data reports your company uses that are not described in the RFI and SOW K. Office of Information and Technology (OIT) The VHA is in a lengthy transition of Electronic Health Records (EHR) from the Vista/CPRS federal record, to a commercial EHR. It is estimated, this transition will span over a 10-year period. The VHA utilizes both an Application Programming Interface (API) and the standard Health Level 7 (HL7) within specified VHA functions to support the integration of data from these platforms with the Veteran s corresponding EHR. Both EHR s will need to be supported through the entirety of this contract. How would your company manage two separate IT production systems over the length of this potential contract, one using API and one using HL7? If VA moves to a cloud-based structure, describe your experience with using cloud-based services specifically, any experience with using the VA cloud. List/describe other OIT considerations that are not described in the RFI and/or SOW (see section 9.1). L. Transition Period The VHA recognizes the need to ensure continuity of services during any contract transition period associated with the award of new contracts. The underlying goal with all contract transitions will be to ensure the continued uninterrupted delivery of products and services to Veterans. Such a contract transition should be done in a way to be the most patient centered and cost effective for the VA. Describe how supporting legacy devices in the field, replaced through attrition only, affects your business model? What other factors could impact the transition period of devices and/or services? M. Product Lifecycle and Change Management Define and discuss your organization s hardware product lifecycle management and software change management tools, techniques, and processes ranging from design, development, implementation, use, ongoing support, and replacement if necessary. In addition, the respondents must highlight their processes that address any issues (e.g. patient safety) are identified, reported and mitigated in a timely manner. N. Help Desk Describe any issues with meeting the SOW (see section 10.1) Help Desk functions and capabilities. O. Additional Innovative Features VHA would be interested in exploring additional features available for RPM-HT. Please describe any additional features your company can provide to include but not limited to: Use of Avatars Chat (live chat between patient and care coordinator) Screen sharing between the patient and the care coordinator Educational libraries-either via text or educational videos Voice options (example ability to change/modify voice on hub) Other capabilities P. Logistics In regard to Return Merchandize Authorizations: 1. Would your company be able to accept products directly from Veterans? 2. Could your company ship replacement items/devices to Veterans? Q. Additional information 1. Please provide other relevant product information that has not been previously described.
Data sourced from SAM.gov.
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