36C25022Q0223.docx

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

GENERAL INFORMATION

Network Contracting Office 10 8888 Keystone Crossing Suite 1100 Indianapolis IN 46240

POINT OF CONTACT*

Contract Specialist Erik Fallo erik.fallo@va.gov 240-215-0608

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Notice of Intent to Sole Source Requirement

The Department of Veterans Affairs, VA Healthcare System, VISN 10 Contracting Activity intends to negotiate a sole source contract under Simplified Acquisition Procedures and the authority of FAR Part 6.302-1, Only One Responsible Source for the following items listed below. The associated NAICS code for this is 339112. The vendor will be Edwards Lifesciences, LLC, One Edwards Way, Irvine, CA 92614.

Description of equipment requirements:

Line Item 1: Hemosphere Advanced Monitoring System – HEMAQSR2 Quantity: 2 Line Item 2: Pressure Controller Cover – PCCVR Quantity: 2 Line Item 3: Hemosphere Roll Stand – HEMRLSTD1000 Quantity: 2 Line Item 4: Hemosphere 360 Program 24MO Plan – HEM360Y2 Quantity: 2

A firm fixed price contract with no option years is anticipated and shall be awarded. It is the Government's belief that only the proposed candidate possesses the required capabilities to successfully meet this requirement. It is the Government's intention to solicit and negotiate with only this source.

This notice of intent is not a request for competitive proposals. It is not a solicitation or request for offers. No solicitation package is available. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. Responses must be received no later than 10:00 am on Monday, January 17, 2022.

Erik Fallo Contract Specialist Erik.Fallo@va.gov

Special Notice Special Notice

Special Notice

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: 36C250-22-AP-1821

1. Contracting Activity: Department of Veterans Affairs, VISN 10, Marion Medical Center 2237: 610-22-1-279-0024

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

$107,000.00

HemoSphere advanced monitoring platform which monitors hemodynamic stability and tissue oximetry. This equipment monitors stroke volume, oxygen levels, perfusion levels through the body and heart, and general cardiovascular stability.

The current non-invasive cardiac output monitoring system EV1000 made by Edwards Lifescience is no longer to be supported or serviced effective December 31, 2021. The new Hemosphere system by Edwards Lifescience will be the replacement to the EV1000s. This equipment is utilized daily in the ICU setting to provide continuous non-invasive cardiac output monitoring for critical patients.

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

Edwards Lifescience Hemosphere equipment is the only non-invasive cardiac monitoring platform that utilizes two different methods/options for monitoring. There is a finger-cuff option and an arterial line option.

Finger Cuff:

The Acumen IQ cuff unlocks Acumen Hypotension Prediction Index (HPI) software and provides continuous blood pressure and advanced hemodynamic parameters from a noninvasive finger cuff. Acumen IQ cuff gives you noninvasive access to calculated beat-to-beat hemodynamic information for a broad patient population, including patients in whom an arterial line would not typically be placed.

Arterial Line:

Acumen IQ sensor unlocks the Acumen Hypotension Prediction Index (HPI) software. This first-of-its-kind predictive decision support software detects the likelihood of a patient trending towards a hypotensive event. It also attaches to any existing radial arterial line and automatically calculates key parameters every 20 seconds, reflecting rapid physiologic changes in surgical and nonsurgical patients.

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

There are other companies that offer non-invasive cardiac output monitoring with only single platforms, like LiDCO LXi Noninvasive. However, Edwards Lifescience is the only company that offers the dual platform option to meet the criteria Acute Medicine needs to properly monitor critical patients in the ICU.

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. Note: COs are required to make a determination of price reasonableness IAW FAR 13.106-3. See the S19 Open Market (FAR13) Award Documentation Form with Abstract to document price reasonableness.

Erik Fallo Contracting Officer

NCO 10

VHAPM Part 813.106 Page 4 of 4 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020