SDVOSBVOSB Sole Source Justification_Redacted.pdf

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 4 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: 36C248-25-AP-2716

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Regional Procurement Office East, Network Contracting Office (NCO) 08 on behalf of Bay Pines VA Health Care System located at 10,000 Bay Pines Blvd., Bay Pines, FL 33744.

2. Nature and/or Description of the Action Being Approved: The proposed action is to award a sole source award to a Service-Disabled Veteran-Owned Small Business (SDVOSB) for the procurement of the AquaBeam Robotic System, in accordance with the statutory authority permitting other than full and open competition; 38 U.S.C. § 8127(c), as implemented by VAAR 819.7008 - Sole Source Awards to Service-Disabled Veteran-Owned Small Business (SDVOSB) Concerns and Veteran-Owned Small Business (VOSB) Concerns.

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

System is required to provide advanced treatment options for patients with benign prostatic hyperplasia (BPH) at the Bay Pines VA Medical Center. The system uses Aquablation therapy, combining high-velocity waterjet and robotic technology for precise tissue removal.

Quantity: (1) PBR AB2000 – AquaBeam Aquablation System

(1) PBR AC-1 YR – Aquacare 1 Year Service Period Estimated Value:

Period of Performance: 90 Days ARO

The Urology section within Surgical Service provides a full range of outpatient and inpatient services.

Urology already sees patients with BPH who require surgery. Urology at Bay Pines VAHCS offers transurethral enucleation procedures such as Holmium Laser Enucleation of Prostate (HoLEP).

Aquablation technology will allow for the resection of prostate tissue without using heat as well as, utilizing the dual imaging system to see the anatomy through both the cystoscopic view as well as, the dual plan ultrasound. It provides an option for patients with larger prostate volumes that require HoLEP or simple prostatectomy, thus preventing the inconsistencies encountered in Community Care (for HoLEPs) or reduce invasiveness for those undergoing Simple Prostatectomy.

The AquaBeam Robotic System is intended for use in patients suffering from lower urinary tract symptoms (LUTS) resulting from benign prostatic hyperplasia (BPH). The AquaBeam Robotic System utilizes a high velocity sterile saline waterjet to ablate prostate tissue during a minimally invasive surgical procedure called Aquablation therapy. This is the only athermal robotic resection of the prostate available on the market. The AquaBeam Robotic System incorporates real-time visualization utilizing cystoscopy in conjunction with bi-plane transrectal ultrasound (TRUS) imaging to allow the operating physician to identify the desired area of resection within the prostatic cavity.

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 2 of 4

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). Contracting Officers (CO) 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):

Pursuant to 38 U.S.C 8127(c), COs may use other than full and open competition when awarding to SDVOSB and VOSB firms for procurements under the Simplified Acquisition Threshold (SAT). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7008 (DEVIATION) Sole source awards to a certified service-disabled veteran-owned small business up to $5,000,000. It is recommended that this requirement is sole sourced to the SDVOSB IAW Sole source awards under 41 USC §3304(a)(5), 38 U.S. Code § 8127(c), as implemented by FAR 6.302-5 (Authorized or Required by Statute).

Furthermore, according to VAAR 819.7008(a), “(a) A contracting officer may award a contract to a certified service-disabled veteran-owned small business (SDVOSB) listed in the SBA certification database using other than competitive procedures provided—

(1) The anticipated award price of the contract (including options) will not exceed $5 million;

(2) The requirement is synopsized and the required justification pursuant to FAR 6.302-5(c)(2)(ii) is posted in accordance with FAR part 5;

(3) The SDVOSB has been determined to be a responsible contractor with respect to performance;

and

(4) In the estimation of the contracting officer contract award can be made at a fair and reasonable price that offers best value to the Government.”

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:

Sources Sought Synopsis: A sources sought notice was issued on Contract Opportunities under Notice number 36C24825Q0895 on 06/17/2025 with a due date of 06/24/2025 at 12:00PM EST. No responses from any capable vendors, other than the authorized SDVOSB, Veterans Healthcare Supply Solutions (VHSS), which was confirmed by the manufacturer as the only authorized distributor. The vendor is active with no exclusions in the System for Award Management (SAM) and is listed in both Veterans Small Business Certification (VetCert) and the Small Business Administration/Dynamic Small Business Search (SBA DSBS).

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

Reasonable: The anticipated cost will be considered fair and reasonable comparing the information on the Electronic Catalog System (ECAT) price schedule for SPE2D1-23-D-0007, awarded to VHSS, which is published by the Defense Logistics Agency (DLA). Supplies offered on the schedule are listed at fixed prices. VA has determined the prices of supplies under scheduled contracts 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 efforts include queries on SBA Dynamic Small Business Search (DSBS), Veteran Small Business Certification (VetCert), Federal Procurement Data System (FPDS), General Services Administration and System for Award Management (SAM).

The North American Industry Classification System (NAICS) code is 339112 (Surgical and Medical Instrument Manufacturing); 6515 (Medical and Surgical Instruments, Equipment, and Supplies).

There is no nonmanufacturer class waiver for the NAICS code 339112 for Surgical and Medical Instrument Manufacturing listed on the NMR Class Waiver Database. Any set-aside would require that the vendor provides a small business manufactured good. Procept BioRobotics Corporation is registered in SAM as a small business for NAICS code 339112; therefore, this requirement can be set aside for an SDVOSB.

FPDS was queried utilizing the keywords "AquaBeam” and filtered for the Department of Veterans Affairs and 36C248. The most recent award was made to Veterans Healthcare Supply Solutions, Inc (SDVOSB) on 05/22/2025 under 36C26225P1228 for “AquaBeam Handpieces” in the total procurement value of $161,248.20. Also, an award was made to the same SDVOSB on 12/02/2024 under 36C24125P0112 for “Procept BioRobotics AquaBeam Service Plan Agreement”.

Although the VA Rule of Two cannot be met on the open market for this requirement requirement, there is one SDVOSB vendor that is the manufacturer’s only known distributor interested in this requirement. It has been verified that Veterans Healthcare Supply Solutions, Inc is currently the only authorized distributor for the AquaBeam Aquablation manufactured by Procept BioRobotics Corporation.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: None. According to 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) up to $5,000,000.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: A sources sought was issued on 6/17/2025, in which a response was only received from the authorized distributor for the AquaBeam Aquablation manufactured by Procept BioRobotics Corporation on 7/2/2025.

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 VA will continue to monitor the market for new entrants and technological advancements. Efforts will be made to identify additional SDVOSB/VOSB sources in future procurements.

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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 the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.