P03. Urgent JA NKV330 Ventilators.pdf

Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 3 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C244-25-AP-1174

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C244-25-AP-1054

Contracting Activity: Department of Veterans Affairs, VISN 04, Pittsburgh VA

Medical Center, University Drive C, Pittsburgh, PA 15240-1003.

2237: 646-25-1-233-0132.

Nature and/or Description of the Action Being Processed:

The Critical Care Department has a new requirement to purchase twenty (20) Nihon Kohden NKV330 Ventilators to replace the current ventilators that are on FDA recall.

The estimated award will be a new firm fixed price contract in the estimated amount of $ .00.

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

The Critical Care Department is set to purchase twenty (20) Nihon Kohden ventilators.

Respiratory ventilators are essential medical devices that assist patients who are unable to breathe adequately. They play a crucial role in various healthcare settings, particularly during respiratory illnesses, surgeries, and critical care situations. These ventilators must comply with stringent regulatory standards established by health authorities, such as the FDA, to ensure they are safe and effective.

Currently, the FDA has recalled the existing ventilators and urgently requires their replacement to prevent failure, ensure patient safety, and maintain continuous care during critical times.

Statutory Authority Permitting Other than Full and Open Competition:

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

(X) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR

6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

VHAPG Part 806.3 OFOC Page 2 of 3 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C244-25-AP-1174

The field of respiratory medicine is rapidly evolving, with new ventilators featuring advanced capabilities that enhance patient care and outcomes. Upgrading from recalled models allows healthcare providers to utilize these advancements effectively.

After the FDA's recall of Philips ventilators, the Nihon Kohden NKV330-STD-T-ZA system is now the only invasive/non-invasive ventilator on the market that offers both ETCO2 and SpO2 monitoring, along with high-flow therapy. It also uses the same circuit as existing non-invasive models, ensuring a quick transition.

In summary, replacing recalled ventilators is crucial for improving patient care, maintaining safety standards, and ensuring effective respiratory support in urgent situations.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Due to unusual and compelling urgency as stated in 41 USC §3304(a)(2) and implemented by FAR 6.302-2, we did not consider any other options. This unit facilitates the replacement of the recalled units while replacing two units. Additionally, it uses the same circuit as the existing non-invasive models, ensuring a smooth and quick transition.

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

Reasonable: Market Research indicates that several contracts awarded to Nihon Kohden have similar prices to the quote provided to the facility by the Original Equipment Manufacturer (OEM) and comparable to the IGCE.

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

1. Federal Procurement Data System (FPDS): Two results were identified, both awarded to the Original Equipment Manufacturer (OEM).

2. Electronic Contract Management System (ECMS): Forty-four results were found; access was limited to three, which pertained to a different ventilator.

3. Adds Up: Five total results, with four related to the same ventilator, awarded to one Service-Disabled Veteran-Owned Small Business (SDVOSB).

4. SCMC, ECAT, GSA Library Search, and VA NAC: No relevant results found.

In summary, while some sources provided information, many did not yield pertinent data for the procurement.

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

No, due to the urgency of the requirement.

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

A quote was obtained from the Original Equipment Manufacturer (OEM) Nihon Kohden America, LLC.

VHAPG Part 806.3 OFOC Page 3 of 3 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: 36C244-25-AP-1174

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 Contract Specialist (CS), an expert in procurement, conducted an extensive search for information related to procurement. The findings indicate that no additional actions will be taken to promote competition for future acquisitions of this requirement. This decision is due to the Pittsburgh VAMC's need to replace all of their current ventilators under FDA recall, ensuring a smooth transition.

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.

Matthew Edwards Date Contract Specialist NCO4, Commodities 2

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

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

Robert Neal, Lead Contracting Officer NCO4, Commodities 2

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

William DeQuinzio, Branch Chief NCO4, Commodities 2

Date

Date

MATTHEW EDWARDS

Digitally signed by MATTHEW

EDWARDS

Date: 2025.02.28 11:38:24 -05'00'

ROBERT NEAL

Digitally signed by ROBERT

NEAL

Date: 2025.02.28 11:32:30 -05'00'

WILLIAM

DEQUINZIO

Digitally signed by WILLIAM

DEQUINZIO

Date: 2025.02.28 13:06:07 -05'00'