RPPM - PWS DRAFT RFI.docx

PERFORMANCE WORK STATEMENT

1.0 BACKGROUND AND OBJECTIVES

1.1 Background

Veteran’s Health Administration (VHA) objective is to establish new innovative technologies used for early detection and prevention of diabetic foot ulcers (DFU) and subsequently related complications such as amputations. The implementation of this technology is expected to increase access to care for diabetic Veterans, which could lead to more efficient and effective treatment. Remote Patient Pedal Monitoring (RPPM) is an early detection mechanism that monitors at-risk Veterans in their personal environment using a thermal imaging mat and/or scanner to perform daily temperature measurement of their foot.

This program will contribute to the standardization of guidelines and protocols in remote care of diabetic Veterans through the uniform management of connected device data. It will generate objective data and promote quality care towards the overall reduction in diabetic limb amputations. Finally, patient use cases and feedback will be used to refine the processes, effectively adapting it to the Veteran Environment. Veterans will benefit from increased self-management and better access to effective diagnosis and treatment.

Daily monitoring has the potential to reduce the burden of DFUs to Veterans, improve Veteran access to needed preventive care, and reduce costs incurred by the VHA treating diabetic foot complications.

The thermal imaging device, which is not a sock or shoe insert, remotely monitors temperature of the feet every day. The thermal imaging device shall be intended, suitable, and designed for safe and effective daily use by Veterans in a home environment, not a clinical setting. The data is monitored by the contractor utilizing VHA Clinical Standard Operating Procedures (SOP) outlined in the most recent version of VA National RPPM Guidance SOP released by the VA Office of Connected Care (Attachment TBD). The contractor shall then notify VA of identified clinical problems as an early warning system that enables VA providers to intervene early to prevent the ulcer from forming.

Under this contract, VHA will lead the expansion of remote temperature monitoring at the VA, with the goal of enrolling a minimum of 10,000 Veterans and up to 100,000 Veterans. This will be achieved through the procurement and deployment of Remote Pedal Monitoring Devices.

“Device” as used in this document, refers specifically to a thermal imaging-based remote pedal monitoring mat and/or scanner that meets the requirements defined in this performance work statement (PWS).

1.2 Objectives:

The objectives of this contract are to:

A. Establish a multiple award contract that can serve the entire United States and its territories for medically prescribed home telehealth remote pedal monitoring to eligible Veteran beneficiaries using standardized ordering processes.

B. Leverage the Department of Veteran Affairs enterprise account to establish favorable pricing for Remote Pedal Monitoring services and supplies through cost savings by streamlining internal processes and billing practices in conjunction to current commercial standards.

C. Contract will be used as a primary source by VHA. Other Government agencies (if authorized by the VA NAC/CSAS), may use the contracts as a source. If authorized, other Government agencies may procure contract line items as a single purchase order outside of the Denver Logistics Service’s (DLS) Remote Order Entry System (ROES) by directly contacting the Contractor(s).

2.0 SCOPE:

The Contractor shall provide remote pedal monitoring solutions that include devices and monitoring services in accordance with the Performance Work Statement (PWS). Veterans are issued devices through clinical prescription and use the Remote Pedal Monitoring technologies which upload data relevant to early detection of DFUs. These technologies help Veterans self-manage their condition and simultaneously alert caregivers or medical personnel to the need for active care/case management, including referral for clinic and/or hospital care. The data is transmitted from the device to the device manufacturer for monitoring services. If the data meets escalation criteria set forth in the Remote Monitoring for Amputation Prevention SOP, it is referred to the Office of Connected Care (OCC). The data is then distributed to the appropriate care team for the purposes of managing the health conditions of the Veteran.

The RPPM device automatically collects and sends patient owned data, in near real time transmission, to a Contractor owned server that is located outside the secure VA hosted environment. Once received, the data is stored on the contractor’s server and then forwarded via encrypted email to OCC before being distributed to VHA clinicians over the VA network.

Please note that the VA is working to integrate contractor systems with VA systems to eliminate the need for encrypted emails to share patient care data. The future state will allow escalation reports to go directly from the contractor system to the patient’s electronic health records.

The VA utilizes both an Application Programming Interface (API) and the standard Health Level 7 (HL7), within specified VA functions, to support the integration of data from these Medical Device Data System (MDDS) platforms with the Veteran’s electronic medical record. The VHA is currently in a planned 10-year transition of the Electronic Health Records (EHR) from the Vista/CPRS federal record to a commercial EHR (Oracle).

Contractor(s) shall successfully integrate and coordinate all activities needed to execute the requirement. The Contractor(s) shall manage the timeliness, completeness, and quality of problem identification. The Contractor(s) shall provide corrective action, plans, proposal submittals, timely identification of issues, and effective management of subcontractors. The Contractor(s) shall seek to ensure customer satisfaction and professional and ethical behavior of all Contractor(s) personnel.

The Contractor(s) shall be responsible for any subcontract management necessary to integrate work performed on this requirement and shall be responsible and accountable for subcontractor performance on this requirement. The Prime Contractor(s) shall manage work distribution to ensure there are no Organizational Conflict of Interest (OCI) considerations. Contractor(s) may add subcontractor to their team after notification and approval of the Contracting Officer (CO).

3.0 Minimum Technical Requirements:

The requirements for this contract are a combination of information technology (IT) requirements and clinical requirements associated with the purchase of supplies with services attached. The General Service Fee will cover support service requirements for both remote patient monitoring and the reporting of clinical data by the contractor.

3.1 Minimum System Requirements:

3.1.1 System Requirements

A. All data transmitted wirelessly shall meet FIPS 140-2 Level 2 standards or its successor, in accordance with VA security policies outlined in PWS Section 3.1.

B. The contractor shall maintain patient health data for a minimum of six years in accordance with VA directive 6500.6 Appendix C, as referenced in PWS Section 5.3.

C. The contractor shall apply appropriate administrative, technical, and physical safeguards to protect the privacy of medical records and other protected health information (PHI) as required by HIPAA.

D. The system must be compatible with all major browser platforms utilized by the VA (Internet Explorer, Edge and Chrome).

E. The system must maintain robust API infrastructure to support Rest APIs, HL7 and FHIR EMR integrations which allow for solutions that support existing clinical and patient workflows.

F. System shall be capable of storing and retrieving patient identification information in accordance with the HL7 and API Functions.

G. All contractor systems shall be able to record and store patient information simultaneously by an Integration Control Number (ICN) or Electronic Data Interchange Personal Identifier (EDIPI) or a Social Security Number (SSN). Patient information shall be retrievable by ICN, EDIPI or SSN (for continuity of operations).

H. All the data collected for a patient shall be stored in such a manner that it can be viewed historically regardless of the VA facility that requested the patient care or data center that supported the patient.

I. The contractor shall maintain a standardized method for enrollment and disenrollment of each patient with longitudinal display of data for all currently enrolled patients over the whole course of the enrollment period.

J. Contractor systems need to have the capability to integrate with VA digital health management system or application.

K. The contractor shall have a method to resolve patient correlation errors, i.e. serial number discrepancies and provide a contact team to address patient correlation problems with the DLC Telehealth Support Group (such as duplicate patients or incorrectly identified patient). This method and team must be capable of resolving all correlation/serial number discrepancies. Patient correlation error communication shall be done by emailing the DLC at DALCTelehealthSupport@va.gov with any errors and/or patient correlation disconnects.

L. Contractor shall test and validate all updates/upgrades to ensure full system functionality, compatibility with existing infrastructure, and no degradation in performance.

M. The contractor shall test and validate all updates/upgrades through VA-approved testing procedures to certify compatibility with APIs, HL7® FHIR®, and VA’s existing Connected Care infrastructure, as required in PWS Section 3.1.

N. Contractor shall schedule and perform all software updated and upgrades outside of standard patient care hours to eliminate any potential operational impact as determined by usage trend analysis.

O. The contractor shall provide advance notice of any scheduled updates/upgrades to the Contracting Officer (CO) and Contracting Officer Representative (COR) at least 2-3 business days prior to implementation.

P. Upon completion of any update/upgrade, the contractor shall provide a Post-Update Report to the CO and COR within one business day detailing:

· Changes implemented

· Confirmation of successful deployment

· Any identified issues and their resolutions (if applicable)

· System performance validation and status post-update Q. Prices for all products shall include warranty, delivery to the DLC, and all user/training manuals.

R. Contractor shall follow all policies outlined in the most recent version of the VA National RPPM Guidance SOP released by the Veterans Health Administration (VHA) Digital Health Office, Connected Care.

S. Contractor shall follow all instructions contained within the Performance Work Statement (PWS) for this contract.

3.2 System Operational Requirements:

A. API Support: Contractors shall support both REST-based APIs and HL7® FHIR® (Fast Healthcare Interoperability Resources) APIs to enable seamless data sharing with the VA’s systems. This includes capabilities for:

1. Securely transmitting patient temperature data in real-time.

2. Supporting both synchronous and asynchronous data exchanges.

3. Ensuring interoperability with the VA’s existing Connected Care infrastructure.

B. Integration with VHA Connected Care Systems: Contractors shall ensure their monitoring devices and services solutions can:

1. Integrate directly with VA Connected Care web applications for data ingestion.

2. Provide real-time event-driven notifications for clinical escalations.

3. Enable monitoring and tracking of patient temperature data within the VA ecosystem.

C. Flexibility for Clinical Workflows: Contractors shall ensure the system can:

1. Trigger workflows or notifications for clinical events requiring intervention.

2. Provide customizable thresholds for temperature monitoring and alerts.

D. Testing and Certification: Contractors shall:

1. Undergo VA-approved testing to certify compatibility of their APIs and systems.

2. Demonstrate successful data exchange and error-handling mechanisms.

E. Comprehensive Documentation: Contractors shall provide:

1. Detailed API documentation for both REST and FHIR endpoints.

2. Guidelines on authentication, authorization, and data formats.

3. Support resources for integration troubleshooting and maintenance.

F. All data transmitted wirelessly shall meet FIPS 140-2 Level 2 standards or its successor

3.3 Minimum Technical Requirements for RPPM Devices, Warranty, and Services.

The technical requirements in Section 3.1 above apply for the RPPM Devices, Services, and Data Management.

This section identifies additional minimum technical requirements for the RPPM Devices, Warranty, Monitoring Services, and Customer Support.

3.3.1 Device:

A. Device shall be compliant with the US Trade Agreements Act (TAA) and cleared by the FDA through the 510(k) process, unless determined exempt under 21 CFR Parts 862-892 per PWS Section 5.4.

B. Connectivity shall be self-configuring and not require patient or Care Coordinator to configure IP addresses, communications ports, or data exchange rates.

C. Device shall use simple touch technology (e.g. push button or touch screen that does not require the patient to use a computer mouse or keyboard).

D. Device shall capture, store, and transmit patient data through VA approved secure communication methods with all VHA Electronic Health Records (EHR).

E. Device shall be configurable to allow features not approved or endorsed by VA to be disabled F. Device shall have temperature sensors for feet with temperature data tracking and monitoring.

G. Device shall measure plantar foot temperature using contact temperature sensors.

H. Device shall transmit collected temperature data via wireless or cellular connection to a remote server for automatic processing, long-term storage, and analysis.

I. Device shall be calibrated to provide temperature measurement accuracy of +/- 0.6 deg Celsius and a precision of +/- 0.3 deg C over the entire temperature range of 15 to 35 deg C.

J. The temperature data shall be digitized and transmitted to be calibrated into temperature units.

K. Temperature sensors shall be stable, reliable, and accurate for the entire service life of the device.

L. The sensor failure rate shall be 3% or lower for readings.

M. Device shall be capable of receiving software updates/upgrades and RPPM requirement updates remotely and in accordance with applicable security and compliance requirements.

N. The device shall provide minimum of 30 days of storage for collected data in case of prolonged use without wireless or cellular access. Device shall transmit saved data once connected.

O. Device shall identify key locations on the feet and compare the temperature between the feet, or in the case of patients with only one foot, compare the temperatures to previous readings.

P. The device shall not take longer than 60 seconds to record requisite data and must be accessible while sitting or standing.

Q. Transmission of data from all devices shall be disabled within 24 hours of patient disenrollment.

R. Rechargeable batteries will hold a charge of no less than four weeks S. Battery life will be displayed on the device interface and monitored remotely to enable outreach as required.

T. Batteries requiring a charging station shall be rechargeable lithium-ion polymer batteries or equivalent/higher grade.

U. Charging stations shall be medical grade.

3.3.2 Warranty:

A. Contractor shall provide unlimited warranty for the duration of the contract up to five years.

B. The warranty shall be an unlimited warranty and shall replace any device that fails to meet its performance specifications at no expense to the VA or patient.

C. Contractor shall maintain remote device quality monitoring service to ensure devices are operating accurately and reliably and shall provide replacement under warranty if substandard device performance levels are observed.

D. If the device is damaged or broken upon delivery, the contractor shall replace it under warranty at no cost to the patient or VA.

E. Returns will be sent to the DLC if the device was not used by the patient. If the device was used, and requires special handling for disposal, it will be returned to the contractor, who shall pay the cost of shipping and comply with disposal protocols outlined in PWS Section 6.5.

3.3.3. Monitoring Services:

A. Contractor shall follow all policies outlined in the most recent version of the VA National RPPM Guidance SOP (attachment A) released by the VA Office of Connected Care.

B. Contractor must provide alerts via secure electronic transmission when an escalation occurs within 24 hours of scan and ensure risk-stratified data is transmitted clearly to VA care providers, as required in PWS Section 3.4. A copy of the report must also be included with the alert.

C. Contractors shall provide scripts to VA program personnel for approval prior to use with patients and shall follow all instructions found in the PWS, Section 3.4 - Clinical Data Components.

D. Services shall be configurable to allow features not approved or endorsed by VA to be disabled.

E. Contractor shall provide a service support function that will be available to the patient for their entire enrollment in the program.

F. The service support function shall provide outreach calls for onboarding, training, re-engagement, wellness, offloading, inflammation checks, inflammation resolution, and technical support.

G. Contractor shall provide the same support as stated above for re-enrollments and when devices are replaced.

H. Contractor shall reach out to patients when data has not been received from the device for more than four consecutive days.

I. Contractor patient support teams shall provide wellness check-ins and monthly usage reports for patients.

J. Contractor shall provide monthly summary reports that are imported into EHR.

K. Contractor shall provide monthly adherence information, quarterly newsletters, and additional educational materials.

L. Safety reports shall not exceed 1% of all VA issued devices.

M. All safety incidents shall be relayed to VA care provider and program office the same day it is discovered/reported to contractor.

N. Safety reports require contractor follow up with report to program office, that includes corrective actions, NLT 5 business days from notification of incident.

O. Satisfaction surveys will at a minimum evaluate patients’ experience with training, device use, patient support team interactions, and program satisfaction.

P. Patient surveys shall show no less than 85% of patients provide the highest rating for ease of use.

3.3.3.4 Customer Support:

A. Contractor shall comply with all instructions contained in the PWS, Section 3.5 - Customer Service.

B. Each patient upon receiving the device, must receive training by telephone from a registered nurse, including standardized offloading and educational support as defined in PWS section 3.3.

C. Patients will receive a welcome package which includes, at a minimum, a user manual and quick start guide. The patient support team shall ensure these items are included and shall review both documents with the patient via phone.

D. User/Training Manuals – all written communications and directions for the patient training manuals shall be written at a sixth grade or below readability level as determined by Microsoft Word’s Readability Statistics that indicate the Flesch-Kincaid Grade Level.

E. Cleaning instructions shall be provided in the user manual and during training with the Patient.

F. Contractor(s) shall provide customer support from 8:00 AM - 11:00 PM Eastern Time (ET) Monday through Friday and as needed on Saturday, Sunday and Federal Holidays to, at a minimum, cover inbound calls and messages, and to report any scans that require escalation. For Guam, American Samoa, Hawaii, and Saipan, the same hours will be covered in local time. Customer outreach must be performed during these hours.

G. Contractor shall provide toll-free technical support to help patients resolve technical issues with a live representative.

H. Devices shall be monitored remotely to ensure accurate and reliable operations and support team will reach out to patients to troubleshoot issues if needed.

3.4 Optional Desired Capabilities for RPPM Devices and Services

These desired capabilities, as described in the product literature, are above the minimum technical requirements, but not required. For proposals that include desired capabilities, a higher rating may be assigned during the evaluation process. These desired capabilities will also be taken into consideration when determining the best value to the government and a fair a reasonable price.

The following capabilities are optional but desired by the VA.

The Contractor(s) shall ensure that all equipment delivered under contract is patient ready and meets all safety requirements. Equipment shall be checked by the Contractor(s) for configuration, calibration, and electrical current leakage. Leakage shall conform to industry safety standards.

The following capabilities are optional but desired by the VA.

A. Two-way messaging B. VA approved educational libraries or videos for the Veteran C. Ability to refurbish D. Device will display when a patient is compliant, as well as not compliant, for every 24-hour period E. Temperature sensors which flex and contour to the shape of the foot F. Use of temperature units to form a thermogram for analysis G. Capture and display the weight of a patient H. Capture images of the feet to identify and provide visual analysis of abornmalities

3.5 General Service Fees

The General Service Fee (GSF) compensates the Contractor(s) for services identified throughout this PWS that support the device. Invoicing of GSF fees will be made monthly in arrears. Payment will be proposed as $X/patient/month. Charges invoiced for Veterans using the service for less than the full month will be pro-rated on the basis of the number of patient days of actively deployed service compared to a 30-day month. Active deployment criteria consist of units and/or services actively transmitting patient data that is viewable by the Care Provider via approved data sharing methods. The Contractor(s) shall calculate the number of patient days of actively deployed device/service every month in arrears according to guidance provided in Attachment TBD. The VA will validate this submission. The Contractor(s) shall maintain and provide accurate and current patient data reflecting equipment/modality utilized for each month. Payment will be limited to charges the VA determines to be in accordance with the Contract. For this contract, there will only be one pro-rated monthly General Service Fee paid per currently enrolled patient to the Contractor(s).

The GSF compensates the Contractor(s) for service costs included but not limited to the following:

A. The General Services Fee covers all data transmissions for all contracted technologies B. Supports OIT infrastructure and interfaces for all RPPM patients using the applicable VA Electronic Health Record (e.g. VistA and Federal EHR).

C. Maintain a complete duplicate of the server system and replicate all VA patient-associated data in real time.

D. Provide the necessary capacity and functionality to support patient care as prescribed in the PWS.

E. Upgrade and update the software on the Contractor(s) servers and RPPM technologies.

F. Systems monitoring and support of the associated operating system and applications.

G. Capacity management and regular upgrades of server, operating system and applications as needed, and the Systems Development Life Cycle (SDLC) shall align with VA hardware and software.

1. VA standards and requirements on back up and redundancy of data.

2. System Monitoring

3. Equipment and Software Procurement, Provisioning, Deployment, and Maintenance

4. Help Desk Support

5. Infrastructure and Architecture Support

6. Program, Project, and Release Management and Deployment Support

7. Training development and delivery

8. Data communication support

9. The costs of supplying all contractually required data, reports, and files, both individual patient and population level.

10. The process of enrollment requires the contractor's clinical staff to reach out via phone within 3-5 business days from shipment to train Veterans on the proper use of their new remote monitoring devices. The contractor's clinical staff shall also monitor each patient's remote monitoring data and reach out to the patient if there are concerning data trends. The contractor's clinical staff shall implement standard offloading/education approved by VA and collect subjective information from the Veterans. The contractor shall notify the patient's VA care team within 24 hours of any concerning data trends or clinically concerning findings reported by patients.

11. Programming and implementing monitoring requirements listed in the most recent version of VA National RPPM Guidance SOP released by the VA Office of Connected Care (Attachment TBD).

12. Programming and implementing all changes to RPPM monitoring protocol scripts necessitated by regular reviews, by upgrades, or by urgent changes necessitated for patient safety reasons.

13. Making the patient data available to the VA Care Team on the VA Network.

14. Any other associated licensing fees (e.g. security certificates)

15. Compliance with all changes and updates to applicable federal laws, VA Policy, Procedures, Directives, and Handbooks.

3.5 Patient Management Protocols and Clinical Data Ownership

A. RPPM Clinical Protocol Scripts

RPPM Patient Management Protocols are structured clinical communication tools and algorithms used by contractors when interacting with Veterans as part of the RPPM program. These protocols help enable patients to self-manage their conditions, facilitate timely care, and support shared decision-making with their providers.

Each protocol script includes the following standardized elements:

· Questions that elicit information about patient scan results

· Questions that elicit information about health-related behaviors

· Questions that query a patient’s knowledge of their condition

· Questions to assess health promotion factors

· Information that is provided to patients to support self-management

· Flags and/or alerts to be presented for risk stratification sent to the VA Care Team

There are two categories of RPPM Patient Management Protocols:

1. Vendor-Developed Protocol Scripts

Vendor-developed protocol scripts are scripts that the vendors have developed and implemented based on the clinical needs identified for patient populations. These protocols are subject to initial review by the VA RPPM Oversight Staff to ensure basic adherence to VA Clinical Practice Guidelines, as defined in the latest VA National RPPM Guidance SOP. Use of these protocols at the VISN or local level requires approval from the VISN or local Chief Medical Officer or authorized designee. Protocol ownership remains with the vendor but is subject to Government approval and oversight.

2. VHA Standardized Protocols

These protocols are developed by the VA and provided to vendors as Government Furnished Information (GFI). Vendors may not rename or alter the content. These scripts are derived from evidence-based clinical practice within the VHA and are considered public domain under 17 USC §101 as Works of the United States Government. Use of this content outside VHA does not imply endorsement.

a. Implementation, Deployment, and Support Requirements:

All RPPM platform devices and services delivered under this contract shall support the implementation of both VHA Standardized and Vendor-Developed Patient Management Protocols. The following requirements apply:

· The most current VA Clinical Practice Guidelines, available in the National RPPM Guidance SOP, shall be followed.

· There shall be no ability for RPPM clinical staff to free text and alter protocol script templates.

· Prior to deployment, vendor-developed protocols shall be submitted with tracked changes and a clean conformed copy for VA RPPM Oversight Staff review.

· All protocol content changes—whether safety-related or part of routine annual review—must be visible and verifiable in the live system (admin view). Contractors shall provide written notification quarterly confirming changes were implemented.

· The patient monitoring data shall be risk stratified for Care Provider review. It shall be clearly presented and verifiable to identify which Care Provider received the report and the date/time the report was accessed.

· The price for use of Vendor-Developed Protocols must be included in the General Services Fee.

· RPPM protocol scripts shall be available to VA RPPM Oversight Staff for review and approval electronically. These will be viewable via a printer friendly option, browser, or a separate test database. The sample protocol scripts should not be populated by VA patient data.

· VHA RPPM protocol scripts shall be provided to vendors upon award and with any new development.

· All new or revised VHA RPPM protocol scripts will be subject to pre-acceptance testing by the VA RPPM Oversight Staff.

· The vendor shall ensure that “patient safety” updates shall be completely updated and ready to deploy to Veterans by removing content of concern from the RPPM protocol scripts within 5 business days from the time the VA notifies the Contractor(s) of a need for protocol script update. If the VA chooses to correct or add new content with new messages, a definitive plan and timeline shall be developed by the vendor within 5 days.

· Each standard VHA RPPM protocol script will be reviewed annually by VA RPPM Oversight Staff. Any changes required by VA in response to the Annual Review shall be provided to Contractor(s) in a definitive version by the 5th of the first month in each CY Quarter. An RPPM protocol script message is any individual statement or question. A message shall be considered new when it does not currently exist in the most recent version of VA National RPPM Guidance SOP released by the VA Office of Connected Care. Patient safety items identified in the Annual Review shall still meet the modification requirement listed under Requirements for both Vendor-developed and VHA Standardized RPPM protocol scripts above.

· Calendar Year (“CY”) Quarter shall mean: Q1 (Jan-March), Q2 (April-June), Q3 July-Sept), Q4 (Oct-Dec).

· The Annual review schedule will follow these guidelines:

· VA delivers a final version approved to vendor by 5th of first month in each VA CY Quarter.

· The VA shall provide the vendor with the following:

· The most current version of the RPPM protocol scripts with the identification of changes noted on the document. (e.g. tracked changes)

· The final, clean copy of the RPPM protocol script to be implemented. The document will reflect only the most current version (no notations of past year’s revisions).

· Prior to submitting to the vendor, the VA RPPM Oversight Staff will check the RPPM protocol scripts during the Annual review for the following:

· Spelling mistakes, Grammar mistakes (Ex: Correct sentence structure -Their/There, You’re/Your)

· Title changes or version control

· Clear notification and detail of changes

B. Clinical Data: Date/Time Stamp Standards

All biometric and patient-reported data must be accompanied with an accurate date/time stamp to ensure it is accurately documented in the patient’s official VA electronic medical record. The date/time stamp is required for the following:

· The date/time the patient collected the data.

· The date/time the device transmitted the data to the vendor server.

· The date/time the vendor transmitted the data to the VA.

· The date/time the vendor contacted the Veteran, if applicable.

National standards have been defined for the date/time stamping of RPPM data. The VA will require Contractor(s) to conform to these standards and the associated business rules found in Attachment TBD.

VA requires that Contractor(s) have processes in place to ensure patient data acquired from their RPPM platforms is captured with an accurate date/time stamp or is flagged as having a questionable date/time stamp to ensure data integrity.

Upon request, the Contractor(s) shall provide applicable lab and clinical testing that provides verification of accurate date/time stamping for all platforms. Overall, validation processes shall demonstrate how the Contractor’s technology can be used with utmost confidence of date/time accuracy 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 VA electronic medical record.

3.6 Customer Service

A. Customer Service for Device and Veteran Patient Support:

Contractor(s) shall provide a customer support help desk for VA personnel (including Veterans) over a 1 - 800 phone line and e-mail support from 8:00 AM - 11:00 PM Eastern Time (ET) Monday through Friday and as needed on Saturday, Sunday and Federal Holidays to, at a minimum, cover inbound calls and messages, and to report any scans that require escalation. For Guam, American Samoa, Hawaii, and Saipan, the same hours shall be covered in local time. During help desk hours, the Contractor(s) shall respond to requests for support within five minutes via telephone or e-mail. Support includes the RPPM devices, the user account management (VA staff and Veterans), the RPPM application software support, and the associated RPPM Protocol scripts. Any clinical issues that may be raised to the Contractor’s help desk shall be re-directed to the assigned VA RPPM Care Provider, medical provider, or emergency 911 services, as appropriate. A website with clinical and technical information shall also be available to VA staff 24 hours by 7 days a week.

Contractor ensures that all systems, devices, and associated services do not have unscheduled outages (excluding scheduled outages and VA interruptions). Monthly unscheduled outages should not be more than:

· More than 0 major outages per month that exceed 4 hours

· No more than 1 incident lasting 1-4 hours

· No more than 3 incidents lasting 60 minutes or less

B. Customer Service for Program Office and Clinical Support:

Contractor(s) shall provide a contact support number to the COR for urgent technical, patient safety or other risk management issues at all times. All such communications for urgent technical, patient safety, or other risk management issues, shall be formally communicated:

· Email and phone notification within 10 minutes of any outage to the program office/COR/CO.

· Email and phone notification within 10 minutes of any data breach or suspected data breach to the OI&T program manager, program office, COR, and CO.

The Contractor(s) shall accept customer service complaints/concerns that are generated within VA by RPPM or other staff. Customer Service complaints will be entered by VA staff in the form of Quality Improvement Reports (QIR). Vendors are required to respond to the QIRs IAW VA National RTM Guidance SOP and this PWS.

The contractor shall submit a weekly Contractor(s) Support Log to the OI&T program manager, RPPM Oversight Staff, CO, and COR. It shall include but is not limited to:

· Quantity of reported issues

· Highlighted patient safety issues

· Date and time of reported issue including resolution date and time, VA site affected, VA staff reporting the issue and specific details regarding the issue reported, device serial number upon request

3.7 Training Requirements

A. Clinical Staff Training

All training shall include instructions and/or demonstration as applicable for installation and use of patient equipment, use of any software, cleaning and refurbishment of equipment, and troubleshooting guidelines. Printed and/or electronic materials for each trainee participant shall also be provided for this training. Training shall occur for all affected VA staff members in conjunction with the initial purchase of any new RPPM equipment and or software by a VA facility and for any major changes or upgrades to equipment or software. This training can be offered on-site, web-based or via video training.

Additional on-site training may be requested from the individual facilities or Program Office.

These training visits would not be at government expense and may occur quarterly at a central VISN facility or conference location, identified by appropriate RPPM Program Oversight Staff. Web-based training or videoconferencing shall be provided for additional site participation during the on-site trainings. This training will not be at additional government expense and shall be included as part of the General Service Fee.

B. Veteran Patient Training (Telephonic or Virtual)

The Contractor(s) clinical staff shall initiate contact with each Veteran patient within a three to five business days after device shipment for routine orders and 1-2 business days for emergency orders. During this contact, the contractor shall:

· Provide telephonic training on device setup and use

· Review offloading/educational materials approved by VA

· Provide troubleshooting support and address questions

· Ensure understanding of daily usage requirements

Each Veteran shall receive a welcome package including:

· User manual (6th - grade reading level, font size 14, with visuals)

· Quick start-guide

· Cleaning instructions

· Contact information for support

Patient interactions and training sessions must be documented in accordance with VA SOP and retrievable upon request.

C. Training Development, Delivery and Life Cycle Management:

OCC will oversee the development of training for clinical providers on Remote Patient Pedal Monitoring technologies, ensuring alignment with VA and VHA standards, as well as compliance with Section 508 requirements. The National Podiatry Program Office will serve as the clinical support and subject matter expert. The Contractor(s) shall provide all the materials to OCC for the development and lifecycle management of training plans, training courses, and supplementary/reference training materials in multiple modalities. Training courses and materials (including all electronic versions) shall comply with VA and VHA branding and style, privacy guidelines, and Section 508 requirements. All Veteran education material shall be written at no higher than a 6th grade level. Manuals identified in Section 3.6.C shall be used to support but not replace the required structured training content described in Sections 3.6.A and 3.6.B.

Training materials must include the following:

· User Manuals

· Quick-Start Guides

· FAQs

· PowerPoint Presentations (Required for care provider only)

Contractors are encouraged to provide supplemental training materials, which may include:

· Instructional or How-To Videos

· Interactive Media

· Podcasts

· Web Slide Shows

Clinical training for RPPM equipment, systems, and software shall conform to the Shareable Content Object Reference Model (SCORM) standard for e-learning interoperability and shall be produced as a compiled Shareable Content Object (SCO). OCC will be responsible for uploading, launching, and maintaining all training plans, courses, and materials in the appropriate VA training portal, which are currently hosted using the Drupal Content Management Framework, LifeRay Content Management System, Blackboard Learn Platform, and/or VA’s Talent Management System (TMS). OCC shall deliver digital health technology training to VA clinicians and staff. The Contractor(s) shall provide the Veteran end-users training both virtually and on-site. The Contractor(s) shall also provide production and logistical support for training delivery.

OCC shall provide training program support including course inventorying, process improvement, course evaluation and surveying, and technical writing and coordination support for training course accreditation.

3.8 Manuals

1. Service Data Manuals

The Contractor(s) shall furnish two (2) copies of a printed and/or electronically available service data manual for all contracted products to the COR. Manuals shall be provided in conjunction with the initial contract award (within 20 business days) and for any major changes or upgrades to equipment or software (10 business days prior to the planned implementation). This manual shall include pictures and/or illustrations, schematics, and complete repair/test guides as necessary with initial purchase and with any major change or upgrades. Where applicable, it shall include electrical data and connection diagrams for all required utilities. The instructions shall also contain a complete list of all component replacement parts to include part number, name, and quantity required. The electronic copy of this document can be provided as an email attachment or available for download from website.

2. Patient User Manuals

The Contractor(s) shall furnish one patient user manual, handbook or brochure containing operating, installation, and maintenance instructions for use by patients with each platform purchased. These manual(s) shall utilize a size 14, Veranda or Arial font. Content shall be written to a 6th grade reading level and the use of pictures and diagrams shall be used in a manner to facilitate patient understanding. An optional electronic copy of this document may be made available to the patient when requested. Training materials need to be 508 compliant for visually and hearing impaired.

3. Clinician User Manuals

The Contractor(s) shall furnish one copy of a clinician user manual, handbook and/or brochure containing operating, installation, cleaning, maintenance, and refurbishment instructions for use by clinical staff members. The electronic copy of this document can be provided as an email attachment or available for download from website for Care Provider review.

4.0 Contract Administration

4.1 Ordering Periods

The contract ordering periods are anticipated to span five (5) years, encompassing a base one (1) year ordering period with four (4) one-year option periods. The ordering period is expected to begin on or about March 1, 2026, once the Contractor(s) successfully receives fully authorized Memorandum of Understanding (MOU) through VA Security and the DLS, as well as approval from Podiatry Program Office, Office of Connected Care, and Prosthetics (PSAS).

4.2 Transition Period

The VA recognizes the need to ensure continuity of services during any contract transition period associated with the award of new contracts. For all new Contractor(s), the ordering period follows per Section 4.1. If an incumbent Contractor(s) receives an award under this solicitation, they shall maintain previously assigned platforms for one (1) year after the initial purchase of the device. The underlying goal with all contract transitions will be to ensure the continued, uninterrupted delivery of products and services in accordance with the terms and conditions of this contract and minimal disruption to Veterans enrolled in the program.

4.3 Guaranteed Minimum

4.3.1 Minimum Guarantee:

The minimum guarantee for this contract is $2,500. This minimum guarantee is established for the base period and not for each optional period of performance. The guaranteed minimum will be satisfied upon issuance of orders that sum to a total of $25,000 per contract.

4.3.2 Contract Ceiling:

The maximum value of services that the Government may order during the contract performance period is $500,000,000.00, which includes the base year and all option periods (if all option periods are exercised). This ceiling amount shall be a shared among up to two selected contractors under this multiple award IDIQ. Pursuant to FAR 16.504(a), the total maximum quantity of supplies and services under the basic contract for all awardees combined shall not exceed $500 million, including the base and all option periods.

4.4 Contract Type

The contract type selected for this acquisition is a Multiple Award Firm-Fixed-Price (FFP) Indefinite-Delivery Indefinite- Quantity (IDIQ) contract.

The contract line item number (CLIN) structure for this contract is included in the solicitation.

All offerors shall include proposals for each CLIN to meet the minimum requirements of this solicitation, to include all option years and the period covered by FAR 52.217-8 (Option to Extend Services). Capabilities are further defined in Attachment D – Minimum Technical Requirements.

4.5 Contractor(s) Furnished Materials

The contractor(s) shall furnish all items (equipment, medical devices and supplies, materials, manuals, software, hardware, etc.) required to perform the tasks identified in this PWS.

4.6 Government & Contractor(s) Points of Contact

A. Government Personnel:

1. Contracting Officer (CO), Eric Asper – eric.asper@va.gov

2. Contract Specialist (CS), Andrea Torrano – andrea.torrano@va.gov

3. Contracting Officer Representative (COR), Randy Blevins – randy.blevins@va.gov

4.7 Deliverable and Performance

4.7.1 Place of Performance:

The contract will provide service coverage for the entire geographic area of the United States and its territories. The work effort defined in this PWS shall be performed at various government sites and or contractor and or Veteran domicile site both within the continental United States (CONUS) and outside the continental United States (OCONUS) in its territories (Puerto Rico, Guam, American Samoa, Hawaii, and Alaska).

4.7.2 Period of Performance:

The period of performance for this contract is from the date of award through one (1) year from award date, with four (4) option periods of one year each.

4.7.3 Deliverables and Submittals:

The contractor shall refer to Attachment TBD – Deliverables and Submittals Table, which contains deliverables required under the contract. The Government reserves its right to request deliverables, even if such deliverable requirements are not specifically listed on the table.

5.0 Regulatory Requirements, Policy, Procedures, and RPPM Standards

5.1 HIPAA, HITECH, and Privacy

This procurement is subject to the Privacy Act of 1974, Title 38 USC Statutes and Public Law 104-191; Health Insurance Portability & Accountability Act (HIPAA) of 1996; and Health Information Technology for Economic and Clinical Health (HITECH) Act.

5.2 Policies, Directives, Handbooks, and RPPM Standards

All Contractor(s) shall comply with all policies, directives, handbooks, and other standards listed in the Definitions, Acronyms and References of this solicitation (see Attachment TBD).

5.3 Data Ownership and Access

All data collected, processed, transmitted, and stored from the patient by the Contractor is patient owned data. Once the Contractor transmits data relating to patients and staff RPPM activities to a VA network, and in accordance with VA Directive 6500.6 Appendix C (VA Publications), it becomes property of the VA. This data shall be available to authorized VA RPPM staff or provided to the VA at any time requested. This data shall not be communicated to any other bodies/organizations or used, analyzed, summarized, or reported in any way by the Contractor(s) without the signed authorization of VA.

5.3.1 Data Center Provisions:

5.4 Food & Drug Administration (FDA) Regulations

This solicitation provides for the supply of medical devices that must be either cleared for commercial distribution by the U.S. Food and Drug Administration (FDA) under Section 510(k) of the Federal Food, Drug, and Cosmetic (FD&C) Act (i.e., premarket notification) or approved for commercial distribution by FDA under Section 515 of the FD&C Act (i.e., premarket approval), unless otherwise determined to be exempted devices as defined in Title 21 Code of Federal Regulations (CFR) Parts 862-892. Additionally, the medical device manufacturer shall be a registered establishment with the FDA and each medical device shall be listed with FDA in accordance with 21 CFR Part 807. For devices requiring 510(k) clearance, Contractor(s) shall provide the associated 510(k) number and certificate issued by the FDA.

5.5 Section 508 Compliance for Electronic and Information Technology Products

The Contractor(s) shall provide a comprehensive list of all offered specific electronic and information technology (EIT) products (supplies and services) that fully comply with Section 508 of the Rehabilitation Act of 1973, per the 1998 Amendments, and the Architectural and Transportation Barriers Compliance Board's Electronic and Information Technology Accessibility Standards at 36 CFR Part 1194.