JOFOC_819.7008-7009_balloon pump_Redacted.pdf

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 1 of 3 Revision: 03 Effective Date: 06/15/2024

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition

Acquisition Plan Action ID: 36C261-25-AP-0173 JOFOC Tracker ID: FY25 - NCO 21 - 233

1. Contracting Activity: Department of Veterans Affairs, NCO 21 on behalf of VISN 21, VA Southern Nevada Healthcare System located at 5406 E. El Campo Grande Ave., STE 150, Las Vegas, NV 89

USA.

PR: 593-25-1-136-0003

2. Nature and/or Description of the Action Being Approved: This procurement is for a new sole source contract to Marathon Medical Corporation, a Service-Disabled Veteran-Owned Small- Business (SDVOSB) concern. For intra-aortic balloon pumps. The type of contract contemplated will be a firm fixed price. This action will be in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the Format of FAR 6.303-2.

3. Description of Supplies/Services :

This is a sole source by statute for an AC3 Optimus Intra-Aortic Balloon Pumps. The purpose of this requirement is to replace cardiac intra-aortic balloon pumps (IABPs) that are at the end of life and are recommended to be replaced by the FDA. The requirement is for two AC3 Optimus Intra-Aortic Balloon Pumps, manufacturer part number IAP-0700. The IABP systems shall be portable for use in multiple rooms, have IV poles, and shall be currently approved by the FDA and without major recalls or alerts indicating issues with this critical equipment. The equipment shall come with all parts and accessories needed for the systems to function. The acquisition shall include setup of the machines and training for the users. This shall be executed as a new firm fixed-price (FFP) contract.

Independent Government Estimate:

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

Code § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7008 (DEVIATION) or VAAR

819.7009 (DEVIATION) up to $5,000,000. Check the specific VAAR clause used below:

( X ) 819.7008 Sole source awards to a certified service-disabled veteran-owned small business;

or ( ) 819.7009 Sole source awards to a certified veteran-owned small business

5. and/or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority ):

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 2 of 3

Effective Date: 06/15/2024

This action is being sole sourced by statute (VAAR 819-7008) to Marathon Medical for a variety of reasons. The FDA has identified that several other manufacturers are no longer considered safe and recommends phasing out other devices in favor of the Teleflex balloon pump. The station currently utilizes a , which the FDA has recommended to discontinue. The current equipment on site is at its end of life, and needs to be replaced. There are only two known distributors of the Teleflex IABP, (SDVOSB) and (large).

There is only one known device that is FDA approved, the AC3 Optimus Intra-Aortic Balloon Pumps, and given the current safety risks presented by other manufacturers

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

A notice of intent will be posted before solicitation, offering any other distributors or competitors the ability to submit a capability statement to the Government. The Government will review all responses and determine whether to continue with the sole source.

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

Pricing will determined fair and reasonable by utilizing available procurement history as well as the

IGCE.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

An NMR Class Waiver exists, allowing for a SDVOSB sole source.

An email was sent to (manufacturer) on 10/28/24 to confirm distributors and Country of Origin. confirmed that the items are manufactured in the US, and that were the only distributors.

VetCert was utilized, NAICS code 334510 was reviewed, resulting in 322 SDVOSB and VOSBs.

GSA Advantage was reviewed searching for the needed item with no results. A contract with was found on GSA eLibrary ( ), however the needed items are not available.

The SCMC was reviewed, was found, a mandatory IDIQ awarded to

. This contract contains a similar model to the needed item from the same needs are and is priced higher than appropriated funds.

FPDS was reviewed, where was found, previously referenced. was found awarded to on 08/23/2024 in the amount of $ for an Intra-aortic balloon pump.

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 3 of 3

Effective Date: 06/15/2024

SAM.Gov was reviewed, where notice ID was found, an intent to sole source to

The NAC was reviewed with no relevant results.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition : None IAW 38 USC

8127(c).

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

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 :

The Contracting Officer will continue to monitor the industry and market for future acquisitions.

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.

Benjamin Johnson Date Administrative Officer VA Southern Nevada Healthcare System

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Mathew B. Czeshinski Date Contracting Officer

NCO 21