JA 36C26322AP3362 Hemosphere Cardiac Output Monitors_Redacted.pdf

Attachment 1: Request for SDVOSB/VOSB Sole Source Justification Format >SAT

Effective Date: 02/01/2022 Page 1 of 4

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C263-22-AP-3362

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

Suite 300, Coralville, IA 52241

Organizational Activity: Minneapolis VA Healthcare System, Biomedical Department, One Veterans Drive, Minneapolis, MN 55417. PR#: 618-22-2-040-0165.

2. Nature and/or Description of the Action Being Approved:

This is a non-competitive procurement in accordance with VAAR 819.7007 which allows sole-source awards to a verified service-disabled veteran-owned small business (SDVOSB) under 38 USC § 8127(c) where contracts awarded using this authority shall be supported by a written justification and approval described in FAR 6.303 and 6.304, as applicable. This action will result in a new, firm-fixed price contract to a verified service-disabled veteran-owned small business with an estimated cost of $ . The anticipated award date is 9/26/2022 with delivery to be completed within 90 days after award.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The procurement is to replace 18 of the medical center’s Continuous Cardiac Output Monitor units which are used during thoracic surgery procedures and during post-operation recovery in the PACU and ICU. Each unit is an advanced hemodynamic monitoring system.

18 qty HEMOSPHERE ADVANCED MONITORING SYSTEM – CARDIAC by Edwards Lifesciences, Inc. P/N:

ED-HEMCARDIAQ

Includes:

• WIN10 WITH SWAN-GANZ MODULE, OXIMETRY CABLE, PRESSURE CABLES FOR ACUMEN

IQ / FLOTRAC, FORESIGHT, HPI, AND ACUMEN ANALYTICS

• Kit Contains: HEM1, HEMSGM10, HEMBAT10, HEMOXSC100, 2 X HEMPSC100, HEMTOM10, HEMFSM10, HEMDPT1000, HEMQG1000, 70CC2, 10038207001, 194371001, Acumen Analytics

18 qty HEMOSPHERE CLEARSIGHT UPGRADE KIT, P/N: ED-HEMCSMUPG

• Contains: HEMCSM10, PC2K, EVHRS, PCCVR and Windows 10

18 qty PCCVR - PRESSURE CONTROLLER COVER, P/N: ED-PCCVR

• Included with EV1000CS / EVNIUPG-US kits

4 qty HEMOSPHERE ROLL STAND, P/N ED-HEMRLSTD1000

4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC § 3304(a)(5) and 38

USC § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute) allowing Contract Officers to use the non-competitive (sole source) procedures authorized in VAAR 819.7007 to issue sole source awards to a verified service-disabled veteran-owned small business.

Effective Date: 02/01/2022 Page 2 of 4

5. Demonstration that the Contractor’s Unique Qualifications and/or Nature of the Acquisition

Requires the Use of the Authority Cited Above (applicability of authority):

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.

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 subpart

5.2 and, if not, which exception under 5.202 applies:

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 8/31/2022 to 9/6/2022 which produced no responses.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

The prices are comparable to a past award made by our colleagues in a different Network Contracting Office in the same region, and they are comparable when compared to the manufacturer’s pricing. We find the anticipated cost to be fair and reasonable.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market research was conducted on FPDS, GSA, FSS. Additional sources were not located.

Market research included a VIP search using NAICS code 334510 which produced 179 matches.

Though the equipment is proprietary to the OEM, it is also available from one SDVOSB who is the sole distributer of the OEM.

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

Effective Date: 02/01/2022 Page 3 of 4

38 USC § 8127(c) enacted through VAAR 819.7007 allows the Contract Officer to make a sole source award to an SDVOSB.

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

There were no responses to the Intent to Sole Source.

As noted, there are two possible sources. The source that has expressed interest in the acquisition is:

1st American Medical Distributors, Inc.

-SDVOSB verified in VIP -Sole authorized distributor for this equipment for Edwards Lifesciences.

- 151 Heritage Park Dr, Suite 201, MURFREESBORO, TN, -Rep: Roy Rayfield, 615-904-1263

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:

In this particular circumstance, where competition can occur between the manufacturer and their only authorized distributor, discretion is given to the Contracting Officer who has determined, in considering the cost to be fair and reasonable, it is in the best interest of the Veterans Administration to utilize VAAR 819.7007 under 38 USC § 8127(c) and make a sole source award to the SDVOSB distributor.

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.

Faith Broman Date ICU Nurse Manager Minneapolis VA Healthcare System

FAITH

BROMAN

Digitally signed by FAITH

BROMAN

Date: 2022.09.21 15:16:19 -05'00' 9/21/22

Effective Date: 02/01/2022 Page 4 of 4

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.

Wendy Hoeschen Date Contract Officer Network 23 Contracting Office (NCO 23)

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Jameson Schwartz Date Branch Chief

c. NCO DOC Review and Approval: I certify the justification meets requirements for other than full and open competition.

Daryl A. Berg Date Director of Contracting

d. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for other than full and open competition.

Terry L. Spitzmiller Date Executive Director Regional Procurement Office Central (VHA)

Wendy S. Hoeschen 1488945

Digitally signed by Wendy S. Hoeschen 1488945 Date: 2022.09.21 15:45:34 -05'00' 9/21/22

Jameson A.

Schwartz 1455536

Digitally signed by Jameson A. Schwartz 1455536 Date: 2022.09.21 16:12:47 -05'00' 9/21/22

Daryl A. Berg 429170

Digitally signed by Daryl A.

Berg 429170 Date: 2022.09.22 09:44:07 -05'00' 9/22/22

TERRY

SPITZMILLER

Digitally signed by TERRY

SPITZMILLER

Date: 2022.09.22 14:13:26 -05'00'

9/22/22