P03 Single Source Justification_Redacted.pdf

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Notice of Intent to Sole Source- Annual Software Subscription License for the EndoTool
Solicitation number
36C24925Q0291-1
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This document is a Single Source Justification form for a sole source procurement by the Department of Veterans Affairs (VA). The VA's James H. Quillen Veterans Affairs Medical Center (JHQVAMC) is seeking to acquire the EndoTool Intravenous (IV) software system from Monarch Medical Technologies for an Annual Software Subscription License. The specialized glucose management software provides clinical decision support for insulin dosing, utilizing 11 patient-specific physiological factors and an Estimated Residual Extracellular Insulin (EREI) feature that calculates residual insulin in the bloodstream. The software has VA Technical Reference Model approval and is designed to recommend intravenous and subcutaneous insulin transition dosing while maintaining glucose levels within a clinician-determined target range.

The procurement is valued under the Simplified Acquisition Threshold (SAT) of $250,000, with an anticipated award date of no later than 07/30/2025. Market research confirmed Monarch Medical Technologies as the sole manufacturer, and the software is an FDA medical device that leverages machine learning to adapt insulin dosing to individual patient physiology. The contract will cover the period from 07/30/2025 through 07/29/2026, with the software compatible with existing VA computer systems and prepared for future Cerner system updates. The contracting officer, Scott Dickey, has certified the justification as accurate and complete in accordance with federal acquisition regulations.

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VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 1 of 2 Acquisition ID# 36C249-25-AP-2271

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C249-25-AP-2271

1. Contracting Activity: Department of Veterans Affairs (VA), Network Contracting

Office (NCO) 9, 1639 Medical Center Parkway Suite 204, Murfreesboro, TN 37129.

James H. Quillen VAMC (JHQVAMC) 1 Veterans Way, Mountain Home, TN 37684

2237: 621-25-3-091-0072

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

James H. Quillen Veterans Affairs Medical Center (JHQVAMC) Pulmonary Clinic is requesting the EndoTool Intravenous (IV) software system for insulin dosing. This procurement consists of the Annual Software Subscription License. This EndoTool software is a glucose management software system used in all patient care settings to recommend intravenous and subcutaneous transition dosing. The software adjusts and maintains the glucose level within a configurable clinician-determined target range.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

The Monarch Medical Endotool has a feature that no other sources or products can provide. It has 11 patient specific physiological factors to provide clinical decision support in the dosing of insulin. Endotool is an electronic glycemic management system for decisional support of insulin titration that has VA Technical Reference Model approval for use within the Veterans Healthcare Administration (VHA). The Monarch Endotool is the only source that has the Estimated Residual Extracellular Insulin (EREI) feature that allows for enhanced customization by constantly calculating the amount of residual insulin circulating in the blood stream and determining how much insulin is needed to ensure proper patient-specific dosing.

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