JA - Signed - Hemosphere.pdf

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

Revision: 01 Effective Date: 11/15/2024 Page 1 of 3 Acquisition ID#: VA-25-00043242

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: VA-25-00043242

1. Contracting Activity: Department of Veterans Affairs, VISN 4, Network Contracting Office 4 in support of VA Pittsburgh Medical Center, University Drive C, Pittsburgh, PA 15240, support by Purchase Request # 646-25-2-233-0235

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

The VA Pittsburgh Medical Center Critical Care department has a brand name requirement for the purchase of one (1) additional HEMOSPHERE ADVANCED MONITORING SYSTEM - CARDIAC WIN10

WITH SWAN-GANZ MODULE, OXIMETRY CABLE, PRESSURE CABLE FOR ACUMEN IQ/FLOTRAC,

FORESIGHT, AND HPI and accessories. The intent of this contract is to provide our 4EICU with the equipment able to provide critical comprehensive hemodynamic monitoring for the Cardiac Surgery patients.

Total estimated price of this procurement is $65,895.00

The procurement package must include the following:

Item Product Model Product Description Quantity

1 HEM7CARDIAC HEMOSPHERE ADVANCED MONITORING

SYSTEM - CARDIAC WIN10 WITH SWAN-

GANZ MODULE, OXIMETRY CABLE,

PRESSURE CABLE FOR ACUMEN

IQ/FLOTRAC, FORESIGHT, AND HPI

Kit Contains: HEM1, HEMSGM10, HEMBAT10, HEMOXSC100, HEMPSC100, HEMTOM10, HEMFSM10, HEMDPT1000, HEMQG1000, 70CC2, 10038207001, 194371001, Acumen Analytics

2 HEMCSMUPG HEMOSPHERE CLEARSIGHT UPGRADE

Kit Contains: HEMCSM10, PC2K, EVHRS, and Windows 10

3 PCCVR PRESSURE CONTROLLER COVER - PCCVR

Included with HEMAQSR2, HEMCSMUPG, EV1000CS, and EVNIUPG-US kits

4 HEMRLSTD1000 HEMOSPHERE ROLL STAND

Accessory

Revision: 01 Effective Date: 11/15/2024 Page 2 of 3 Acquisition ID#: VA-25-00043242

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

The HEMOSPHERE ADVANCED MONITORING SYSTEM - CARDIAC WIN10 WITH SWAN-GANZ MODULE, OXIMETRY CABLE, PRESSURE CABLE FOR ACUMEN IQ/FLOTRAC, FORESIGHT, AND HPI and supplies have already been approved by the Clinical Product Review Committee (CPRC). The CPRC is a team that reviews any new product that touches a patient that the hospital proposes to introduce in to use. The VA requires a CPRC request entered through the CPRC portal that requests detailed justification and documents, that is subsequently reviewed by the committee members (logistics, biomed, property management, infection prevention, etc.) who vote whether the item can be used or not.

The approved hemosphere monitors are already in use in our ICU units by our ICU nurses who rotate through each unit and are trained on the monitor. To introduce another monitor model would increase the risk for potentially fatal errors when not using consistent equipment. Other monitoring devices would not be compatible with the expendable supplies for the monitor that are approved and currently in use. This could incur additional costs to the facility and require additional training. All the included features in this monitor increase patient safety measures, decrease length of stay, and decrease the 30-day post-surgery mortality rate.

Features that make the Edwards Lifescience HEMOSPHERE ADVANCED MONITORING SYSTEM - CARDIAC WIN10 WITH SWAN-GANZ MODULE, OXIMETRY CABLE, PRESSURE CABLE FOR ACUMEN IQ/FLOTRAC, FORESIGHT, AND HPI unique are:

Acumen Hypotension Prediction Index (HPI) software predicts the likelihood of a patient trending towards a hypotensive event.

Intuitive navigation, and responsive touch for intelligent decision support during rapidly changing situations.

Continuous monitoring platform with noninvasive, minimally invasive, and comprehensive catheter capabilities Detection of Cerebral and tissue desaturations.

Detection of Hemodynamic Instability Cardiac Output (CO) and Stroke Volume (SV) for early detection and management of Sepsis Continuous Hemodynamic monitoring for early detection of Hypotension Comprehensive view of tissue oximetry to ensure continuous oxygen saturation for adequate perfusion Thermodilution and pulse contour analysis to deliver cardiac output and stroke volume updates every 20 seconds.

Continuous assessment and tracking of flow, pressure, and oxygen delivery and consumption to assist in your early evaluation of cardiac performance.

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

The HEMOSPHERE ADVANCED MONITORING SYSTEM - CARDIAC WIN10 WITH SWAN-GANZ MODULE, OXIMETRY CABLE, PRESSURE CABLE FOR ACUMEN IQ/FLOTRAC, FORESIGHT, AND HPI can be purchased directly through Edwards LifeSciences(LB) or their authorized distributor; 1st American Medical Distributors, Inc. (SDVOSB).

Revision: 01 Effective Date: 11/15/2024 Page 3 of 3 Acquisition ID#: VA-25-00043242

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.

Contracting Officer Melvin Moore NCO4, Commodities 1