Attachment 1 - Justification - HemoSphere_Redacted.pdf

SDVOSB/VOSB Sole Source Justification Format IAW VAAR 819.7008/9

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 1 of 6

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A)

Other Than Full and Open Competition

Acquisition Plan Action ID: 36C257-26-AP-4478 JOFOC: FY26-NCO17-2289

1. Agency: Department of Veterans Affairs (VA)

Contracting Activity: Network Contracting Office 17

5441 Babcock Road San Antonio, Texas 78240

Requesting Office: VA North Texas Health Care System (VANTHCS)

Critical Care Unit Dallas VA Medical Center

4500 S. Lancaster Road Dallas, Texas 75216-7167

Purchase Request: 549-26-4-205-0765

2. Nature and/or Description of the Action Being Approved: This J&A supports the award of a new Firm Fixed Price supply contract for the Edwards Lifesciences/Beckton Dickson (BD) HemoSphere Advanced Hemodynamic Monitoring Platform. The action will be awarded as an SDVOSB sole-source procurement under the Veterans First Contracting Program.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The requirement is for the procurement of HemoSphere systems, associated clinical modules, and accessories to support advanced hemodynamic monitoring within VANTHCS. The HemoSphere platform is the only FDA-cleared solution that maintains full interoperability with existing Edwards’ disposables—including Swan-Ganz catheters, ForeSight tissue oximetry, Acumen IQ sensors, ClearSight cuffs, and TruWave pressure transducers.

The Hemosphere Alta must interface natively with all existing Edwards accessories and disposables without adapters, converters, or third-party interface devices. This advanced monitoring system is necessary to maintain current clinical workflows, alarm logic, and monitoring parameters without requiring staff retraining or protocol changes. The system is required to maintain continuity of care, preserve validated workflows, and prevent clinical risk associated with transitioning to incompatible platforms that may compromise output accuracy.

See specifications below:

Minimum Equipment Requirements:

Item Number Item Details Quantity Unit of

Measure

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ALTASRSV2 HemoSphere Alta Smart Recovery Bundle with Acumen IQ/ClearSight, Pressure Cable for Acumen IQ/FloTrac, and Alta 360.

Kit contains: ALTASR1, HEMPC2K, EVHRS, HEMAPSC200,50038354001.

Alta 360 Program 24-month Plan

12 EACH

PCCVR PRESSURE CONTROLLER COVER –

PCCVR Included with HemoSphere, HemoSphere Alta, and HemoSphere Vita bundles, as well as Acumen IQ cuff, ClearSight cuff, and VitaWave cuff module upgrade kits.

12 EACH

HEMRLSTD1000 HemoSphere Roll Stand Accessory

12 EACH

3. Technical Specifications:

Hemosphere Alta Advanced Monitor or equal to Weight: 21 +/- 0.57 lbs (9.7 +/- 0.1 kg) Height: 13.45 in (342 mm) Width: 15.26 in (388 mm) Depth: 8.20 in (208 mm)

Display/Resolution/OS/Speaker Count: Active Area 15.6 in diagonal (396 mm)/1920x1080/Windows 10/ 1 - Speaker

Electrical Rated Supply Voltage: 100 to 240 Vac, 50/60 Hz Rated input: 1.5 to 2.0 Amps

Input/Output Touch Screen: Projective capacitive touch RS-232 Serial Port: 2 Edwards proprietary protocol:Maximum data rate=57.6 kilo baud USB Ports: 3 USB 2.0 (rear) Ports: 1 RJ-45 Ethernet, 1 HDMI Hospital information system connectivity: Wifi integration services are subject to local availability DPT Pressure: DPT Pressure out signal from ClearSight technology is compatible with monitors and accessories intended to interface with Edwards non-invasive pressure signal ECG monitor: Sync line conversion: 1V/mV; Input voltage range: +/- 10V full scale;

Resolution: = +/- 1 BPM; Accuracy = ±10% or 5 BPM of the input, whichever is greater Range: =30-200 BPM; 1/4 in. stereo jack: tip at positive polarity; analog cable

Key Modules and Capabilities ClearSight System: Noninvasive, continuous monitoring using a finger cuff; measures blood pressure (BP), cardiac output, systemic vascular resistance (SVR).

Compatibility: Swan-Ganz (pulmonary artery catheter), ForeSight (tissue oximetry), and Acumen IQ sensors.

Acumen HPI: Provides predictive insight into potential hypotension events (MAP < 65 mmHg).

Functionality Interface: 11 customizable monitoring views.

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Satisfactory performance has been determined through a review of the vendors’ Contractors’ Performance Assessment Records System (CPARS).

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable, including whether a notice was or will be publicized as required by RFO 6.301 and, if not, which exemption under RFO 5.101(b)(1) applies:

The Notice of Intent (NOI) to Award a Sole Source procurement to was issued under 36C25726Q0857, and published to SAM.gov on August 25, 2026. One response was received from Covidien Sales LLC, a large business and authorized distributor for Medtronic’s ARGOS platform.

According to the documentation supplied by the vendor (see 36C25726Q0857 – Response 60-001-Rev-L-English, located in the briefcase), the ARGOS monitor is not compatible with the facility’s existing Edwards hemodynamic monitoring ecosystem. The operator’s manual identifies compatibility with the analog output of the following patient monitors:

1. Philips IntelliVue® Models MP40 and above (MP90, MX700, MX800) which accept the M1006B module with option #C01 Pressure Module

2. GE Carescape® Models with Patient Data Module (PDM) Solar 8000, Carescape B650, Carescape B850

3. Spacelabs Xprezzon®

4. Draeger Infinity®

5. Mindray BeneVision® N series and T series with MPM MP1 Module

6. Nihon Kohden Life Scope G9® BSM-6000®, 3500 and 1700 Bedside Monitors

Neither the Edwards EV1000 platform nor the HemoSphere system is listed as compatible.

As a result, the ARGOS platform cannot be considered a viable replacement for the facility’s existing Edwards-based ecosystem.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: Price reasonableness will be determined in accordance with RFO FAR 12.204(a) based on competitive quotations or offers. Other steps include reviewing historical prices on existing or previously awarded contracts for similar items or services.

8. Description of the Market Research Conducted and the Results, or a Statement of the

Reasons Market Research Was Not Conducted: The program office reviewed multiple clinical and industry sources—including the Critical Care Medicine Journal, MedicalExpo, the American Nurse Journal, and brochures for generally available hemodynamic monitoring products—along with technical materials from Edwards Lifesciences/BD. The subject matter expert (SME) also evaluated comparable platforms manufactured by a large business (LB) GE Carescape, Philips IntelliVue (LB), and Masimo LiDCO (LB). Although these manufacturers provide their own hemodynamic monitoring systems, none are compatible with the facility’s existing Edwards-based ecosystem.

Additionally, no other U.S. manufacturers produce a monitoring system interoperable with the facility’s current Edwards Swan-Ganz catheters, oximetry catheters, Acumen IQ sensors, and ClearSight cuffs. Because the Edwards EV1000 platform is now discontinued, maintaining system compatibility requires selecting a replacement that supports all existing Edwards hardware and disposables. This ensures continuity of clinical workflows, minimizes patient-care risk, and avoids unnecessary cost and retraining.

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Queried multiple federal procurement platforms—Ability One, UNICOR, Medical Supplies Program Office (MSPO), National Equipment Catalog (NEC), General Services Administration (GSA) eLibrary, GSA Advantage, Supply Chain Master Catalog (SCMC), Analytics, Data and Decision Support Unified Platform (ADDS UP), USAspending.gov, System for Award Management (SAM.gov), Small Business Search SBS, and FPDS—to identify eligible SDVOSB, VOSB, small business, and other-than-small-business vendors capable of providing the requested equipment. Results consistently showed that only the OEM (Edwards Lifesciences/BD) and the authorized SDVOSB distributor, 1st American Medical Distributors, Inc., can supply the HemoSphere Advanced Monitoring System.

The vendor, 1st American Medical Distributors, Inc., meets the eligibility criteria outlined in VAAR 819.7003(DEVIATION), as a certified SDVOSB in the SBS VetCert portal, and this action is below the $5M threshold.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

Pursuant to the authority at 38 USC 8127(c) - Sole Source Contracts for Contracts Above the Simplified Acquisition Threshold:

(1) such concern is determined to be a responsible source with respect to performance of such contract opportunity;

(2) the anticipated award price of the contract (including options) will exceed the simplified acquisition threshold (as defined in section 134 of title 41) but will not exceed $5,000,000;

and

(3) in the estimation of the contracting officer, the contract award can be made at a fair and reasonable price that offers best value to the United States.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

One vendor expressed interest in the acquisition; however, they proposed alternative equipment and were not identified as an authorized vendor to supply the required equipment. Market research confirms that vendor interest, without OEM authorization or verified capability, does not meet the threshold for consideration in this procurement. This requirement is a brand-name-only solicitation.

The Notice of Intent (NOI) under 36C25726Q0857 was published to SAM.gov on August 25, 2026. One response was received from Covidien Sales LLC, a large business and authorized distributor for Medtronic’s ARGOS platform.

According to the documentation supplied by the vendor (see 36C25726Q0857 – Response 60-001-Rev-L-English, located in the briefcase), the ARGOS monitor is not compatible with the facility’s existing Edwards hemodynamic monitoring ecosystem. The operator’s manual identifies compatibility with the analog output of the following patient monitors:

3. Philips IntelliVue® Models MP40 and above (MP90, MX700, MX800) which accept the M1006B module with option #C01 Pressure Module

4. GE Carescape® Models with Patient Data Module (PDM) Solar 8000, Carescape B650, Carescape B850

3. Spacelabs Xprezzon®

4. Draeger Infinity®

5. Mindray BeneVision® N series and T series with MPM MP1 Module

6. Nihon Kohden Life Scope G9® BSM-6000®, 3500 and 1700 Bedside Monitors

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Neither the Edwards EV1000 platform nor the HemoSphere system is listed as compatible.

As a result, the ARGOS platform cannot be considered a viable replacement for the facility’s existing Edwards-based ecosystem.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required: Encouraging the original equipment manufacturer Edwards Lifesciences/BD to expand authorized SDVOSB distributor network to increase competition for future acquisitions.

12. Requirements Certification: I certify that the requirement outlined in this justification is a

Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Astrid McKinney Contracting Officer

ASTRID MCKINNEY

Digitally signed by ASTRID

MCKINNEY

Date: 2026.09.03 08:47:15 -05'00'