P03. JA Sole Source Hemosphere Monitoring Systems Omaha VA_Redacted.pdf

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 2

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: 36C263-23-AP-2445

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 23, 1303 5th St.

Suite 300, Coralville, IA 52241

Organization Activity: Omaha VA Medical Center-VA Nebraska-Western Iowa HCS, 4101 Woolworth Avenue, Omaha, NE 68105

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

Estimated Amount: $

The NWIHCS Cardiology section performs 120 ablations and 60 right heart catheterizations each year. These procedures require highly invasive arterial monitoring, which is painful for patients and can cause complications. The Cardiology Section requires non-invasive arterial monitoring capabilities for ablations or right heart catheterizations on-hand. The Cardiology section requests procurement of the HEMOSPHERE Advanced Monitoring system to provide non-invasive arterial monitoring capabilities. This would decrease the potential for complications and improve the patient experience.

- Hemosphere system is especially important for patients on anticoagulants and reduces the risk of bleeds during both procedure and post-procedure periods.

- Hemosphere system is used at 5 other VA sites across the continental United States

- Hemosphere is the only noninvasive monitoring system for Cardiac catheterization and electrophysiology procedures made in the United States

- Hemosphere is the only noninvasive monitoring system for Cardiac catheterization and electrophysiology procedures compatible with NWIHCS Philips Cath Lab components

Models/Part Numbers:

• 2 HEMAQSR2

• 2 PCCVR

• 2 HEMRLSTD1000

• 2 HEM360Y2

• 2 896083021 Cable Assembly

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

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Last Updated: 02/01/22 Page 2 of 2

The unique character of the required equipment is that the required advanced cardiac output monitoring units can perform the following multiple functions in one unit:

-Continuous Hemodynamic non-invasive monitoring (the monitoring of tissue perfusion) that provides continuous blood pressure data and advanced hemodynamic parameters.

-Precise tissue oximetry monitoring, cerebral and somatic, with site specific algorithms.

-Arterial based cardiac output monitoring with the technology to predict hypotensive events.

-Continuous assessment of flow, pressure, oxygen delivery and consumption via an inter-arterial catheter.

Purchasing these brand name units pre-empts the need to purchase multiple separate units of different brands to obtain all of the required functions.

Additionally, the Government requires the arterial based cardiac output monitoring with technology to predict hypotensive events trademarked as “Acumen” which is proprietary and a brand name of Edwards Lifesciences.

4. Description of market research conducted and results or statement why it was not conducted:

Market research revealed there are only two sources that provide the required equipment: the original equipment manufacturer (OEM) Edwards Lifesciences and their sole authorized distributor 1st American Medical Distributors, Inc. an SDVOSB. This was further confirmed in the form of a written letter from the manufacturer.

An Intent to Sole Source was posted to SAM.gov from 8/6/2023 to 8/11/2023 which produced no new responses.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Joseph Bennett, Contract Officer Date

JOSEPH

BENNETT

Digitally signed by

JOSEPH BENNETT

Date: 2023.09 25 01 06:17 -05'00' 9/25/23