Justification for Sole Source.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-SAP under FAR13.5

Effective Date: 12/30/2025 Page 1 of 5 Revision: 02 Acquisition ID#: 36C263-26-AP-0556

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C263-26-AP-0556; Microwave Ablation (MWA) & Cryoablation Procedures

– Nebraska-Western Iowa VA Health Care System

1. Contracting Activity:

Department of Veterans Affairs, Network 23 Contracting Office, Nebraska-Western Iowa VA Health Care System.

Justification and Approval (J&A) in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items.

2237: 636-26-3-1048-0003.

2. Nature and/or Description of the Action Being Processed:

This procurement pertains to Microwave Ablation (MWA) and Cryoablation procedures, conducted in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items. Specifically, under FAR 13.501, these acquisitions, while exempt from FAR Part 6 requirements, still necessitate a justification using the format outlined in FAR 6.303-2.

The contract is a follow-on with Agility Health Inc., the sole vendor capable of providing both MWA and Cryoablation services in support of the Nebraska-Western Iowa VA Health Care System. It will be a firm-fixed-price contract, including a base period and four optional renewal years. The total contract amount will be $720,000.00, with an annual value of $144,000.00. All procedures—both MWA and Cryoablation—will be performed on-site for every case, including instances where Cryoablation is not indicated.

Access to these services is critical for ensuring comprehensive patient care, with our Interventional Radiologists performing approximately 20 to 40 procedures annually. Securing this contract is vital to maintaining uninterrupted access to these advanced treatment options and supporting the best possible patient outcomes.

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

Microwave Ablation (MWA) and Cryoablation Procedures will be provided in support of the Nebraska-Western Iowa VA Health Care System. These services will include the utilization of specialized equipment as well as the deployment of qualified staff to perform the procedures directly at the VA facility. Billing will be conducted on a per-procedure basis, ensuring flexibility and transparency in the service delivery.

The contractor will be responsible for supplying all necessary equipment, maintaining compliance with relevant standards, and providing trained personnel to perform the procedures efficiently and safely. The scope of work encompasses both the base period and four subsequent option years, allowing for continued support and service expansion if required.

Effective Date: 12/30/2025 Page 2 of 5

Acquisition ID#: 36C263-26-AP-0556

Based on the Independent Government Cost Estimate (IGCE), the total estimated cost for providing these services over the entire contract duration—covering the initial base year plus four additional option years—amounts to $720,000. This estimate ensures that all anticipated costs associated with equipment, staffing, and service delivery are appropriately accounted for within the proposed budget.

The following are the costs for each year:

Base Year: $144,000.00 Option Year One (1): $144,000.00 Option Year (2): $144,000.00 Option Year (3): $144,000.00 Option Year (4): $144,000.00.

Total Contract Total: $720,000.00

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):

The procurement described herein is supported by the authority provided under FAR 13.5, titled "Simplified Procedures for Certain Commercial Items." This authority is appropriate for this acquisition because the services required—Microwave Ablation (MWA) and Cryoablation procedures, including the necessary equipment and staffing—are considered commercial items in accordance with FAR Part 2.101. Furthermore, this procurement involves the continued development and support of a highly specialized medical system required for the treatment of veterans at the Nebraska-Western Iowa VA Health Care System. The procedures and equipment involved are classified as a “highly specialized” medical system, designed explicitly for advanced ablation therapies that are not widely available or replicable by other vendors. The capabilities provided by this system are critical for delivering specialized healthcare services and are integral to the VA’s mission of providing comprehensive veteran care.

In this particular case, only one source, Agiliti Health Inc., is capable of providing both the MWA and Cryoablation procedures, along with the associated equipment and trained personnel. This vendor possesses the unique technical expertise, specialized equipment, and operational capacity necessary

Effective Date: 12/30/2025 Page 3 of 5

Acquisition ID#: 36C263-26-AP-0556 to meet the complex requirements of these highly specialized medical services. Due to this exclusivity, the justification for using FAR 13.5 as a sole source is strongly supported, as Agiliti Health Incis the only capable provider capable of fulfilling the government’s needs for both procedures and related services. The use of FAR 13.5 streamlines the procurement process, reducing administrative burdens while ensuring the timely acquisition of these critical services. This approach aligns with the federal regulatory framework and supports the government’s objective of obtaining the best value in a manner that guarantees high-quality, specialized healthcare for veterans. Given the unique and highly specialized nature of the system and services involved, this justification for sole source procurement under FAR 13.5 is both valid and necessary to ensure continuity of essential medical care.

Accordingly, Agiliti Health Inc is the only firm capable of providing the supplies and services described in Section III above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

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

A Sole Source Notice of Intent (36C26326Q0291) was posted on January 27, 2026, with responses due by February 3, 2026, at 11:00 AM CST. Based on thorough research, the only respondent, BHPE LLC (UPDJHPJUYQ71), does not demonstrate specialization in the required services nor has documented experience performing these services. Given the nature of the procurement and the limited pool of qualified providers capable of meeting the specific technical and clinical requirements, efforts to solicit from additional sources were determined to be impractical.

Therefore, the agency has justified proceeding with a sole source acquisition.

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

The Contracting Officer (CO) has reviewed the anticipated costs and considers them fair and reasonable, based on the Independent Government Cost Estimate (IGCE), market research, and the unique capability of Agiliti Health Inc as only one capable vendor exists, these costs are aligned with current market rates.

To ensure fairness, the acquisition will include a detailed technical evaluation, request certified cost or pricing data for thorough cost analysis, and, if necessary, audits by DCAA or other auditors. These steps will verify the accuracy and reasonableness of the final contract price, ensuring it provides the best value to the government.

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

Market Research Was Not Conducted:

As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by a synopsis of the proposed acquisition, advising industry of the pending procurement and soliciting inquiries from interested parties. Based on this thorough research, no other vendor was identified that can provide both Microwave Ablation (MWA) and Cryoablation procedures on-site with the same level of capability, expertise, and reliability as Agilitis Health Inc. Their exclusive ability to deliver both of these advanced, minimally invasive treatment options makes them the only feasible provider capable of fulfilling our clinical requirements.

Effective Date: 12/30/2025 Page 4 of 5

This unique capability underscores the necessity of sole sourcing this contract to Agilitis Health Inc to ensure continuous, unimpeded access to these vital procedures. The absence of alternative vendors capable of offering both services highlights the importance of establishing and maintaining a direct partnership with Agilitis Health Inc. Their specialized expertise and on-site availability are critical for managing approximately 20 to 40 patient procedures annually in an efficient and effective manner. Securing this partnership is essential for supporting our commitment to providing timely, high-quality care to our veterans without unnecessary delays or disruptions.

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

Not Appicable, this is being Sole Source under ther authority of FAR 13.5, titled "Simplified Procedures for Certain Commercial Items."

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

A Sole Source Notice of Intent (36C26326Q0291) was posted on January 27, 2026, with responses due by February 3, 2026, at 11:00 AM CST. There was only one respondent, BHPE LLC (UPDJHPJUYQ71), which does not specialize in the required services and lacks documented experience performing the necessary procedures.

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:

No actions are planned to remove or overcome barriers to competition. The agency intends to proceed with a sole source acquisition as justified, given the unique capabilities and specialized experience required for the services.

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

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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.

John Becker Date Contracting Officer NCO23 Contracting Office

b. One Level Above the Contracting Officer (Required over $350K but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Chara Collins Date Division Chief

NCO23 Contracting Office

c. VHA Advocate for Competition and RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve $900K to $90 million for other than full and open competition.

Name Date VHA Head of Contracting Activity (HCA) https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx