P03_ SSJ MODUS.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for MPT up to SAT

Revision: 02 Effective Date: 12/30/2025 Page 1 of 2 Acquisition ID# 36C241-26-AP-4321

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the Simplified Acquisition Threshold

Acquisition Plan Action ID: 36C241-26-AP-4321

1. Contracting Activity: Network Contracting Office 1, Regional Procurement Office East on behalf of the Department of Veterans Affairs, Veterans Integrated Service Networks (VISN 1), Jamaica Plain VA Medical Center 150 S. Huntington Avenue Jamaica Plain, MA 02130- 4817. Funding 523-26-4-7183-0164.

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount: This is a new, sole-source requirement. Boston�s VA Healthcare System is looking to acquire 12 months of continued support for the CSP2017 Pivotal POP (Percutaneous Osseointegrated Prosthesis) Study, which relies on Modus Health�s StepWatch activity monitors and their proprietary data platform to track how Veterans move throughout their daily lives. The purchase covers the monitors and accessories, the Modus cloud where all study data is uploaded and cleaned, remote training for participating sites, mobile hotspots to keep data flowing reliably, and the specialized data-processing service that generates the metrics the study depends on. Total Amount for one year of service from August 1, 2026 � July 31, 2027, is $82,880.87.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The CSP2017 Percutaneous Osseointegrated Prosthesis (POP) Study employs StepWatch devices and Modus� proprietary analytics to assess secondary endpoints of functional mobility and community ambulation. Boston�s VA Healthcare System requires specific derived metrics produced within the Modus cloud, plus strict turnaround and export capabilities. Substituting another brand device or analytics would require protocol changes, re-validation of endpoints, and would compromise longitudinal comparability with existing data captured under prior contract 36C24121P0844.

The previous period ended on July 8, 2026, and to avoid missed follow-ups and data gaps, this action must start August 1, 2026. Only Modus Health LLC can lawfully provide the required proprietary metrics, device compatibility (UDIs), and the project-specific cloud pipeline used by CSP Boston. Modus Health LLC is the original developer of the StepWatch devices and the only source for the secure, project-specific cloud and algorithms already

Year 1 CR app and cloud annual fee 1 $20,411.49

Data cleaning fee 1 $55,809.38

Hot spots service fee 1 $2,580.00

Remote training fee 3 $3,000.00 JAMF device management 1 $1,080.00

Year 1 Total $82,880.87

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for MPT up to SAT

Revision: 02 Effective Date: 12/30/2025 Page 2 of 2 Acquisition ID# 36C241-26-AP-4321 used under contract 36C24121P0844, continuing with them is the only way to maintain seamless, scientifically valid data collection as the study moves into its next year.

4. Description of market research conducted and results or statement why it was not conducted: Market research was limited for this requirement because it is a follow-on to contract 36C24121P0844, and the CSP2017 POP Study relies on Modus Health�s proprietary StepWatch devices, data-cleaning algorithms, and the project-specific Modus cloud, which are integral to the study�s longitudinal data collection. The proprietary nature of the StepWatch system and its analytics pipeline prevents other vendors from providing compatible devices or data-processing services without disrupting the study design. Internal communications confirm that the prior contract ended and the requirement must continue without interruption, with instruction from leadership to proceed with sole sourcing due to timing and the study returning to research. This establishes that only Modus Health LLC can satisfy the study�s technical, proprietary, and continuity needs. Accordingly, further market research was not conducted, as no alternative sources exist that can provide the StepWatch hardware, UDI-matched devices, the CSP-specific Modus cloud environment, or the validated data-cleaning outputs required for protocol compliance. This research directly supports VA�s Statutory Mission 3, �To conduct health care research,� and fulfills the VA�s mandated obligation under 38 U.S.C. § 7303, Part (B) to conduct prosthetic research that advances care for Veterans with limb loss. The clinical trial cannot proceed without continuous StepWatch data collection, because these mobility measurements are the scientifically validated endpoints required to evaluate safety, efficacy, and long-term functional benefit of the prosthetic intervention. The study�s results will inform future VA clinical practice, prosthetic procurement decisions, and national policy regarding rehabilitation support for amputee Veterans. Continuation of this requirement is therefore mission-critical, legally mandated, and foundational to ensuring high-quality, evidence-based care for this Veteran population. This will be sole sourced to large business Modus Health requires as Boston�s VA Healthcare System needs 72-hour raw data availability and quarterly cleaned datasets from Modus� pipeline no later than August 1, 2026. No other source can lawfully provide Modus� derived metrics or guarantee equivalency without licensing or re-validation.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR 13.106- 1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Gail Grundy Date Contracting Officer

NCO 1/ RPO EAST