Attachment 1 Single Source Justification MPT to SAT1_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: 36C244-23-AP-0654

1. Contracting Activity: Department of Veterans Affairs, VISN 4, Pittsburgh Medical Center-University

Drive University Dr. C Pittsburgh, PA 15240. PR: 646-23-1-233-0027

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

Pittsburgh VAMC has a new brand name request for the P/N HEMCARDIAQ HemoSphere Advanced Monitoring System. The HemoSphere advanced monitoring platform provides a comprehensive view of hemodynamics and tissue oximetry, giving you data to inform your clinical decisions. From one monitor, you can continuously monitor your patient using both oxygen saturation and hemodynamic parameters to ensure they remain adequately perfused.

Line No. Part No. Description QTY

0001 HEMCARDIAQ HEMOSPHERE ADVANCED MONITORING SYSTEM

CARDIAC WIN10 WITH SWAN-GANZ MODULE, OXIMETRY

CABLE, PRESSURE CABLE FOR ACUMEN IQ / FLOTRAC,

FORESIGHT, HPI, AND ACUMEN ANALYTICS Kit Contains:

HEM1, HEMSGM10, HEMBAT10, HEMOXSC100,

HEMPSC100, HEMTOM10, HEMFSM10, HEMDPT1000,

HEMQG1000, 70CC2, 10038207001, 194371001, Acumen Analytics

0002 HEMCSMUPG HEMOSPHERE CLEARSIGHT UPGRADE

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

0003 PCCVR PRESSURE CONTROLLER COVER - PCCVR

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

0004 HEMRLSTD1000 HEMOSPHERE ROLL STAND Accessory 2 0005 HEM360Y2 HEMOSPHERE 360 PROGRAM 24MO PLAN Covers Model(s) listed under "Total Protection Program Highlights"

The estimated value of the proposed action is $

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Brand Name Edward Lifesciences has the only modular hemodynamic monitoring platform to offer full-range cuff, sensor, and catheter compatibility and first-of-its-kind hypotension predictive decision support software, HemoSphere advanced monitor enables proactive individualized patient management.

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

Brand Name Edwards Lifesciences monitors include the latest technology in hemodynamics monitoring by providing cardiac output, cardiac index, systemic vascular resistance, and tissue oxygenation by means of an arterial line. It provides actual metrics on fluid and cardiac status. It provides cerebral tissue oxygenation readings, vascular pressure, and flow parameters to achieve optimal tissue perfusion. Decreasing hypotensive episodes may prevent acute kidney injury, decreasing 30-day post-surgery mortality.

The oximetric pulmonary catheter can monitor advanced vascular hemodynamics as well as tissue oxygenation and continuous cardiac output. It provides goal-directed fluid therapy, decreasing fluid overload or hypovolemia. It increases patient safety by providing advanced hemodynamic monitoring and predictive artificial intelligence. It is expected to decrease the length of stay by utilizing the early recovery software, and guiding interventions to achieve goals. It can provide critical information after cardiac surgery by providing numbers without an invasive line. The Critical care service line is also interested in utilizing this technology for cardiac surgery patients post-operatively, thus utilizing these monitors will enhance the continuity of care across the peri-operative period.

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

Sources Sought Synopsis (36C24423Q0177) was posted from 11-25-22 to 12-02-22 and produced zero (0) responses.

S dor Information Pages, VetBiz Portal, SBA Dynamic Small Business Search, DLA Troop Support Medical Electronic Catalog (ECAT), GSA Advantage, GSA eLibrary, Interagency Contract Directory Portal, VA National Acquisition Center Contract Catalog Search Tool (CCST), and VA Supply Chain Master Catalog found zero (0) vendors.

S System-Next Generation found two (2) vendors: Edwards Lifesciences LLC (Large Business) and 1st American Medical Distributors, Inc. (SDVOSB).

Based on the above Market Research, Edwards Lifesciences LLC (Large Business) and 1st American Medical Distributors, Inc. (SDVOSB) are the only vendors that can provide the necessary requirement. A Non-Manufacturer Rule waiver was found but the Rule of Two has not been met.

The Contract Specialist anticipates issuing a Brand Name Unrestricted Solicitation on the Open Market. This market research is less than 12 months old.

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.