6515--Supplies - OnX Heart Valves Consignment - Surgery Ann Arbor VAMC

Special Notice Special Notice Page 2 of 2 Page 1 of 2 Special Notice *= Required Field Special Notice Page 1 of 2 Page 1 of 1 Notice of Intent to Sole Source Requirement: The Department of Veterans Affairs, VA Healthcare System, Network Contracting Office (NCO) 10 intends to negotiate a sole source contract under Simplified Acquisition Procedures and the authority of FAR Part 13.106-1(b)(1)(i), Only One Responsible Source for the following items listed below. The associated NAICS code for this is 339113. Description of Inventory Items: Consignment agreement for the following items: OnX Aortic Conform Ext 19 / ONXACE-19 OnX Aortic Conform Ext 21 / ONXACE-21 OnX Aortic Conform Ext 23 / ONXACE-23 OnX Aortic Conform Ext 25 / ONXACE-25 OnX Aortic Conform Ext 27/29 / ONXACE-27/29 OnX Mitral Standard 25 / ONXM-25 OnX Mitral Standard 27/29 / ONXM-27/29 OnX Mitral Standard 31/33 / ONXM-31/33 The sole source contract will be awarded to: Artivion, Inc., 1655 Roberts Blvd NW, Kennesaw, GA 30144-3632, United States. A firm fixed price contract with four (4) option years is anticipated and shall be awarded. It is the Government's belief that only the proposed candidate possesses the required capabilities to successfully meet this requirement. It is the Government's intention to solicit and negotiate with only this source. This notice of intent is not a request for competitive proposals. It is not a solicitation or request for offers. No solicitation package is available. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. Responses must be received no later than 12:00PM EST, Wednesday, July 16, 2025. LouAnn Gilliland Contract Specialist contact@example.gov DEPARTMENT OF VETERANS AFFAIRS Justification and Approval For Exception to Fair Opportunity Memo Acquisition Plan Action ID: 36C250-25-AP-2049 Contracting Activity: Department of Veterans Affairs, VISN 10, Network Contracting Office (NCO) 10, located at 3140 Governor s Place Blvd., Suite 210, Kettering, Ohio, 45409, has been requested by the Ann Arbor VA Medical Center, 2215 Fuller Road, Ann Arbor, Michigan, 48105-2303, to procure a 5-year Consignment Contract for OnX Heart Valves Surgical Implant Consignment. Description of Action: The proposed Sole Source order will be for various sizes of Aortic and Mitral mechanical heart valves to be used within the Surgery Service. This Open Market, Firm-Fixed Price Consignment (total of 5-years) will have 1-each of sizes requested by Surgery Service on the shelf at all times for scheduled/emergency surgeries. The OEM is a Large Business, with no Small Business distributors: Artivion, Inc., 1655 Roberts BLVD NW, Kennesaw, Georgia 30144-3632. Description of Supplies or Services: The proposed action is to provide access to veterans in need of Aortic/Mitral Mechanical Heart Valve surgeries. This will be a 5-year Consignment, where the contractor will ensure that the requested items are on the shelf at all times, to support critical and life-saving equipment to veterans. OnX Aortic and Mitral valves are the only mechanical valve with FDA approval for Low INR of 1.5-2.0. While other manufacturers can also provide these like items, it is the surgeon that will require the specific brand based on the familiarity and training that he/she received for this delicate surgical procedure. 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. ( X ) 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. ( ) 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). Rationale Supporting Use of Authority Cited Above: OnX Aortic and Mitral valves possess unique design features and materials that distinguish them from other heart valve products on the market. These specialized design elements may include superior hemodynamic performance, lower risk of thromboembolism, and potentially fewer complications compared to other mechanical valves. On-X valves may have specific FDA approvals for certain indications or patient populations that other valves do not have. This regulatory distinction further supports the need to procure these valves from the sole source that can legally provide them for the intended use. Given these points, the use of FAR 16.505(b)(2)(i)(B) is justified because the OnX Aortic and Mitral valves meet the requirement of being unique and highly specialized products that only one awardee, Artivion Inc., is capable of providing at the necessary level of quality. If this is a Brand Name Justification: The discussion shall include how the particular brand-name, product, or feature is essential to the Government s requirements and market research indicates other companies similar products, or products lacking the particular feature, do not meet, or cannot be modified to meet, the agency s needs. Include this sentence in your discussion: This is a brand name justification in support of FAR 11.105, Items Peculiar to One Manufacturer. Comprehensive market research has been conducted to identify potential alternatives. This research included reviewing available literature, contacting industry experts, and analyzing similar products on the market. The findings conclusively support that no other suppliers offer a product that meets the unique specifications and clinical requirements provided by OnX valves. Artivion Inc. is the sole manufacturer and authorized distributor of the On-X valves. No other source can provide these valves, as they are protected by patents and proprietary manufacturing processes exclusive to Artivion Inc. 6. Efforts to Obtain Competition: A description of efforts made to ensure that offers are solicited from as many potential sources as is practicable. Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources that can meet the Government s requirements. There is no competition anticipated for this acquisition. In accordance with FAR 5.301 and 16.505(b)(2), this action will be synopsized on SAM.Gov/Contract Opportunities 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: Provide a description of the market research conducted among the contract holders and the results. If market research was not conducted, the reasons it was not conducted should be stated. When citing FAR 16.505(b)(2(i)(b) or FAR 16.505(b)(2)(i)(e), the only possible way to state in paragraph 5 of the J&A that there is only one contractor who can fulfill the agency s needs is to conduct market research, and it should be summarized here. Market Research began with VetCert, using NAICS Code 339113, which found 934 potential vendors. In addition, Contract Opportunities was searched using key word Artivion , which did identify prior RFQ s for these specialized heart valves. eCMS and FPDS confirmed that these items were awarded as an Open Market procurement to the Sole Source vendor, the Large Business OEM, Artivion, Inc. Additionally, SBA, SCMC, GSA were all searched, utilizing key word Artivion , which did not identify any vendors that could provide these items. It should be noted that Artivion, Inc. is the rebranded name of CryoLife, Inc., a name change which occurred on January 10, 2022. Therefore, while this does exceed the 18-month Market Research timeframe, there are additional procurements that were awarded to CryoLife, Inc. prior to January 2022. 9. Other Facts: The Contractor shall furnish and maintain an inventory of implanted mechanical heart valves as required. Products shall be placed in the VAAAHS Surgery Service on a consignment basis in accordance with the terms and conditions of this contract. The Government will be responsible for proper storage and security for all items supplied. The ownership and title of all consigned items shall remain with the Contractor until item(s) are used by the Government. The Government assumes no ownership for any item(s) stored at the VA on a consignment basis until the item(s) has/have been used. The Contractor shall deliver replacement products within 48 hours after receipt of the purchase order. The Contractor shall ship products directly to the Ann Arbor VAMC at no additional charge. 10. Contracting Officer's Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. //signed// LouAnn Gilliland Contracting Officer Richard L. Roudebush VAMC Indianapolis, IN