Exception to Fair Opportunity Justification.pdf

Attachment 1: Request for Exception to Fair Opportunity

36C247-25-AP-4474

Effective Date: 03/15/2023 Revision 02 Page 1 of 2

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval For

Exception to Fair Opportunity Memo

Acquisition Plan Action ID:____36C247-25-AP-4474________

1. Contracting Activity: Department of Veterans Affairs, VISN 7, Ralph H. Johnson VA Medical Center

Medical Center, Charleston SC, 29401 PR# 534-25-4-783-0313

2. Description of Action: The Charleston VA Medical Center is seeking approval to purchase three

Intuitive Surgical da Vinci 5 robotic systems to replace and expand upon our existing robotic surgery capabilities. Currently, the facility operates two da Vinci Xi systems, which are scheduled to be traded in for credit toward the new systems. A new Firm-Fixed Price (FFP) Task Order will be issued off of Indefinite Delivery Contract 36C10G-25-D-0013, which was awarded to SDV Office Systems on 1/31/25 by the Strategic Acquisition Center.

3. Description of Supplies or Services: The Surgical Department has successfully used the da Vinci Xi systems for several years across multiple specialties, including urology, general surgery, gynecology, and thoracic procedures. The da Vinci 5 is the latest advancement in robotic surgery and offers enhanced ergonomics, improved visualization, advanced instrumentation, and greater data integration capabilities. Importantly, the da Vinci 5 system maintains backward compatibility with many Xi system components, ensuring a smoother transition and preservation of existing inventory.

The current Xi systems, while still functional, are becoming outdated and do not support newer instruments and software enhancements now standard in robotic-assisted procedures. The addition of a third system will support the increasing surgical volume and reduce scheduling bottlenecks.

Trading in the two Xi systems for credit directly through Intuitive Surgical will provide a financial offset, making this transition more cost-effective. Maintaining platform continuity ensures minimal disruption to surgical workflows and avoids costly retraining or changes to infrastructure.

The total estimated value of the proposed action is: $7,229,325.00. Delivery shall be made within 90 days of Task Order award date.

4. Statutory Authority: The statutory authority permitting an exception to fair opportunity is Section

41 U.S.C. 4106(c) as implemented by the Federal Acquisition Regulation (FAR) 16.505(b)(2)(i):

( ) FAR 16.505(b)(2)(i)(A): The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

( ) FAR 16.505(b)(2)(i)(B): Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

( ) FAR 16.505(b)(2)(i)(C): The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

( ) FAR 16.505(b)(2)(i)(D): It is necessary to place an order to satisfy a minimum guarantee.

Attachment 1: Request for Exception to Fair Opportunity

36C247-25-AP-4474

Effective Date: 03/15/2023 Revision 02 Page 2 of 2

(X) FAR 16.505(b)(2)(i)(E): For orders exceeding the simplified acquisition threshold, a statute expressly authorizes or requires that the purchase be made from a specified source”. The statutory authority permitting an exception to fair opportunity for this action is 38 U.S.C. 8127(c), known as the Veterans First Contracting Program which provides the authority to directly contract with a Service-Disabled Veteran-Owned Small Business (SDVOSB) or a Veteran-Owned Small Business

(VOSB).

5. Rationale Supporting Use of Authority Cited Above: On February 1, 2025, the SAC established a

Sole Source Requirements Contract 36C10G-25-D-0013 with SDV Medical, LLC. (“SDV”). SDV is the sole distributor of the da Vinci® Robotic device and the suite of accessories, consumables, and allied services. The da Vinci ®System is consistent with Veterans Affairs (“VA”) policies to standardize the types and categories of supplies and services to ensure consistency with patient care and particular needs. Further, SDV will only contract with the SAC on behalf of the VA.

6. Effort to Obtain Competition: There is no competition anticipated for this acquisition. SDV Medical is the sole distributor for this equipment. In accordance with FAR 5.301 and 16.505(b)(2), this action will be synopsized at award on the Federal Business Opportunities page (FBO) and the justification will be made publicly available.

7. Actions to Increase Competition: Describe actions taken, or that will be taken, to remove or overcome any barriers to competition before initiating any subsequent acquisitions for the supplies, or services required, including challenges to restrictive data markings, data rights, preparation of a performance-based work statement, and etc. The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

8. Market Research: Market research was not conducted. A 5-year VA SAC national robotics contract (36C10G-25-D-0013) was established to procure da Vinci equipment as confirmed by David King, Deputy Program Manager, VHA CO Procurement & Logistics Office. Intuitive Surgical is the manufacturer of da Vinci equipment. SDV Office Systems LLC, doing business as SDV Medical (SDVOSB) is an exclusive distributor.

9. Other Facts: NONE