Sole Source Justification - NKV-330 Ventilator.pdf

Attachment 1: Request for SDVOSB/VOSB Sole Source Justification Format IAW VAAR 819.7008/9

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 1 of 3 Revision: 04 Effective Date: 11/15/2024

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition

Acquisition Plan Action ID: 36C242-25-AP-2072

1. Contracting Activity: Department of Veterans Affairs, VISN 02, Buffalo VA Medical Center

Purchase request number: 528-25-2-4085-0039.

2. Nature and/or Description of the Action Being Approved: Network Contracting Office 2 (NCO 2) is contemplating the award of a new firm-fixed-price contract on behalf of the Buffalo VA Medical Center.

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

Center has a need for fifteen (15) Nihon Kohden brand NKV-330 Ventilators and accessories. The NKV-330 is a non-invasive ventilator that provides respiratory support to adult and pediatric patients. The ventilators provide mechanical ventilation by moving breathable air into and out of the lungs, to deliver oxygen to a patient who is physically unable to breathe or is breathing insufficiently.

These ventilators will replace the ventilators that are currently being used by the facility but have been discontinued by their manufacturer. The estimated value of this acquisition is $227,234.55.

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. 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 authority allows sole source awards to SDVOSB/VOSB based on 38 U.S.C. 8127(c) and the SDVOSB concern has been determined to be a responsible source with respect to performance. The business meets the eligibility requirements in 819.7003.

To meet the requirements of the Respiratory Therapy department at the Buffalo VA Medical Center, the ventilators must fully integrate dual HEPA filtration, integrate ETCO2 and SpO2 monitoring, high flow oxygen therapy as a standard option, is not under an FDA recall, has hot swappable external batteries, continuous Co2/SPO2 monitoring, and 72 hours of continuous waveform. Members of the Respiratory Therapy department identified and reviewed three ventilator systems as part of their market research efforts and only the NKV-330 ventilator manufactured by Nihon Kohden America, Inc. met all their requirements.

https://www.va.gov/oal/library/vaar/vaar819.asp#8197008 https://www.va.gov/oal/library/vaar/vaar819.asp#8197009 https://www.va.gov/oal/library/vaar/vaar819.asp#8197009

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

Effective Date: 11/15/2024

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: An Intent to Sole Source notice will be posted to sam.gov before an award is made. In addition, see section 8 for further description of the efforts that were taken to ensure offers would be solicited from as many potential sources as practicable.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The anticipated cost to the Government will be determined fair and reasonable by comparing quoted prices to the Independent Government Cost Estimate, and by reviewing the prices on contracts that were previously awarded by VHA for similar requirements. The quote will also be reviewed by the using service to confirm its technical acceptability. A determination that the price is fair and reasonable will be made before contract award.

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 March - April 2025.

To meet the requirements of the Respiratory Therapy department at the Buffalo VA Medical Center, the ventilators must fully integrate dual HEPA filtration, integrate ETCO2 and SpO2 monitoring, high flow oxygen therapy as a standard option, is not under an FDA recall, has hot swappable external batteries, continuous Co2/SPO2 monitoring, and 72 hours of continuous waveform. Members of the Respiratory Therapy department identified and evaluated three ventilator systems during their market research efforts:

Ventec VOSCN - While the Ventec VOSCN does have 9 hours of battery power, it does not meet the requirements of high flow oxygen therapy, hot swappable external batteries, and were unable to display waveform graphics necessary to evaluate efficacy of inhalation delivery and troubleshooting.

Oxygen delivery is limited to 6l/min or .40 FiO2 which does not meet the needs of a critical care non-invasive ventilator.

Drager Savina 300 NIV - The Drager Savina does offer waveform graphics, but it does not meet the requirements of high flow oxygen therapy and does not offer hot swappable external batteries. The Drager Savina 300 was not FDA cleared for high flow oxygen therapy. It also has a large footprint that would reduce bedside space for critical care devices.

Nihon Kohden NKV330 - Only the Nihon Kohden system had all the salient characteristics required by the Respiratory Therapy department and was determined to be the best device for safe and effective critical care non-invasive ventilation.

A search of VetCert using NAICS 334510 identified 322 SD/VOSB vendors. A search of SBA’s DSBS using NAICS 334510, and keyword “ventilator” identified 0 VOSBs and 1 SDVOSB.

A search of FPDS using keyword “NKV330” identified four contract actions, all of which were awarded to Nihon Kohden America, LLC.

https://www.acquisition.gov/far/part-5#FAR_Subpart_5_2 https://www.acquisition.gov/far/part-5#FAR_5_202

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

Effective Date: 11/15/2024

Nihon Kohden America, LLC is the original equipment manufacturer (OEM) of this equipment. They are not a small business but have provided a letter identifying After Action Medical and Dental Supply, LLC as their one and only authorized distributor of this equipment. After Action Medical and Dental Supply meets the eligibility criteria outlined in VAAR 819.7003, is a VetCert and DSBS certified SDVOSB, and this action is below the $5M threshold.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None; IAW the authority under 38 USC 8127(C).

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

• After Action Medical and Dental Supply, LLC

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: Before the ventilators reach end of life, the Buffalo VA Medical Center will ensure extensive market research is performed in a timely manner to evaluate vendor capabilities with the intent of opening competition to all brands of ventilators that can potentially meet the Government’s requirements.

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.

Name Date Title Facility

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.

Jonathan Kilgore Date Contracting Officer

NCO 2

https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx