P03 FAR 13.5 Sole Source Justification - SAT-9.0M Copy_Redacted.pdf

Effective Date: 11/15/24 Page 1 of 4

REVISION: 01

Acquisition ID#: 36C261-26-AP-1099

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261-26-AP-1099 JOFOC Tracker 26: FY26-NCO 21-290

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Network Contracting Office (NCO) 21, on behalf of the Veterans Integrated Service Networks (VISN) 21, San Francisco VA Health Care System (SFVAHCS).

2237: 662-26-3-045-0034.

2. Nature and/or Description of the Action Being Processed: This procurement is for the provision of supplies and services for the Point-of-Care hemostasis analyzer. The required supplies include QPlus test cartridges, QPlus quality controls (1&2), cleaning cartridges, QStat test cartridges, and QStat quality controls (1&2). This acquisition is conducted in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements. While acquisitions under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, they still necessitate a justification using the format of FAR 6.303-2.

The nature of this action is to request approval to procure supplies and service of Point-of-Care hemostasis analyzer as a sole source, open market action. This is a new requirement that will be awarded under a firm-fixed-price contract. This procurement will be awarded to Hemosonics, LLC a small business, located at 4020 Stirrup Creek Drive, Suite 105, Durham, NC 27703-8970.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Laboratory Medicine Service department at SFVAHCS is requesting supply provision and service of Point-of-Care hemostasis analyzer. Supplies include QPlus test cartridges, QPlus quality controls (1&2), Cleaning cartridges, QStat test cartridges, & QStat quality controls (1&2). The analyzer is VA owned and currently is used at Anesthesia Department.

The estimated total value of the proposed action is $411,500.00 one-year base period with four (4) one-year option periods.

FAR clause 52.217-8, Option to Extend Services will be used if needed to ensure there is no interruption in services to Veterans.

The period of performance would be:

Base Year 04/01/2026 – 03/31/2027 $82,300.00

Option Year 1 04/01/2027 – 03/31/2028 $82,300.00 Option Year 2 04/01/2028 – 03/31/2029 $82,300.00 Option Year 3 04/01/2029 – 03/31/2030 $82,300.00 Option Year 4 04/01/2030 – 03/31/2031 $82,300.00

Effective Date: 11/15/24 Page 2 of 4

Acquisition ID#: 36C261-26-AP-1099

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

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

Hemosonics, LLC is the Original Equipment Manufacturer (OEM) of the Point-of-Care hemostasis analyzer. As the exclusive provider, Hemosonics, LLC is uniquely qualified to supply the necessary supplies and deliver the required services for this system. The proprietary nature of these supplies and services makes Hemosonics, LLC the sole vendor capable of meeting the specific needs of the Department of Veterans Affairs (VA).

Effective Date: 11/15/24 Page 3 of 4

Acquisition ID#: 36C261-26-AP-1099

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

No alternative sources are considered viable. Hemosonics, LLC, as the Original Equipment Manufacturer (OEM), is the exclusive vendor able to provide the essential services and supplies required for this need. The supplies and services offered by Hemosonics, LLC are proprietary, establishing them as the sole source capable of meeting these specific requirements.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: IAW FAR 13.106-3(a)(2), the anticipated cost to the Government will be considered fair and reasonable by comparing the proposed pricing to the independent government cost estimate

(IGCE).

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

Market Research Was Not Conducted:

The equipment Quantra Hemostasis Analyzer is owned by San Francisco VA Healthcare System – Anesthesia Dept. The Anesthesia Dept is requesting supplies (Cartridge kit) and instrument service of Point-of-Care hemostasis analyzer.

Sources Sought Notice was posted on Contracting Opportunities on 11/21/25 and closed on 11/28/2025. No response was received from any vendors.

There is no preventative maintenance except for using a Sani-cloth to wipe down the touchscreen and exterior of the instrument. Product KT-0012, Cleaning cartridge, is run once per week to remove any dust or debris that may build up. Should the equipment fail and requires maintenance, a Field Engineer comes on site to assess and repair the Quantra. They do not have outside sources/vendors who perform maintenance on the Quantra. HemoSonics provided proprietary letter stating that only HemoSonics-authorized personnel are trained and certified to perform service on the Quantra System. Service training is not offered to customers or any third-party service organizations.

HemoSonics LLC, OEM, is the only vendor that can provide the equipment, service and supplies for this requirement. The supplies and service are proprietary to the vendor.

Small Business Administration’s (SBA’s) Small Business Search (SBS) database was used to identify certified capable Service-Disabled Veteran-Owned Small Business (SDVOSB) and Veteran-Owned Small Business (VOSB). The database search utilizing NAICS code 339112 - Surgical and Medical Instrument Manufacturing yielded two (2) SDVOSB and VOSB matches and nine (9) small businesses.

The Non-Manufacturer Rule (NMR) is not applicable to this requirement. Hemosonics, LLC, a small business, is the Original Equipment Manufacturer (OEM).

The vendor, HemoSonics notified that the cartridges and kits are made by them in Raleigh, North Carolina. The Buy American Statute and Trade Agreement Act does not apply.

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

The supplies and service are proprietary to the vendor.

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

Hemosonics, LLC has expressed interest.

Effective Date: 11/15/24 Page 4 of 4

Acquisition ID#: 36C261-26-AP-1099

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 future acquisitions, appropriate market research will be conducted to determine if sources capable of meeting the agency’s needs have become available in the marketplace.

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.

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.

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.