Draft (Pre Decisional) VHAPG Part 806.3 OFOC Page 1 of 4 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C24426AP0796 DEPARTMENT OF VETERANS AFFAIRS Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT) Acquisition Plan Action ID: 36C244-26-AP-0796 Contracting Activity: Department of Veterans Affairs, VISN 04, Lebanon VA Medical Center 1700 South Lincoln Avenue, Lebanon PA 17042. Transaction Number 595-26-1-050-0731 Nature and/or Description of the Action Being Approved: The Lebanon VA has a new firm fixed price requirement for the Plasmax Plasma Kits. The Plasmax concentration system is a specialized device designed to produce a fully autologous plasma concentrate with elevated fibrinogen concentration, which is optimal for haemostasis. It consists of two parts: the GPS III Separator, which produces leukocyte-rich platelet-rich plasma (L-PRP) from a small sample of the patient s own blood, and the Plasmax Concentrator, which produces autologous fibrinogen-rich platelet-poor plasma concentrate (PPPc) using polyacrylamide beads to remove excess water. This system is designed to eliminate concerns regarding pooled blood sources, as it produces an autologous output from the Plasmax Plasma Concentration System. Description of Supplies/Services Required to Meet the Agency s Needs: The Plasmax Plasma Concentration System is comprised of two distinct parts, the GPS III Separator and the Plasmax Concentrator. The GPS III Separator produces leukocyte-rich platelet-rich plasma (L-PRP) from a small sample of the patient s own blood. The Plasmax Concentrator produces autologous fibrinogen-rich platelet-poor plasma concentrate (PPPc) utilizing polyacrylamide beads to remove excess water. Features of the system include: Outputs up to 10 cc of rapidly polymerizing autologous plasma concentrate3 Outputs up to 3 or 6 cc of PRP, depending on which GPS III kit is being used Produces both outputs in less than 20 minutes Autologous outputs eliminate concern regarding pooled blood sources Autologous output from the Plasmax Plasma Concentration System eliminates concern regarding pooled blood sources. Pooled plasma sources found in donor-based fibrin sealants carry the risk of transmitting infectious diseases and viruses. The Lebanon VA requires 1050 kits to be delivered 30 days after the receipt of the order and no there are no options to extend or increase quantities. Total Contract Value: ___________(800-0517 Plasmax Kits Quantity 1050) Statutory Authority Permitting Other than Full and Open Competition: (X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by RFO 6.103-1; ( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by RFO 6.103-2; ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by RFO 6.103-3; ( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by RFO 6.103-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by RFO 6.103-5; ( ) (6) National Security per 41 USC §3304(a)(6) as implemented by RFO 6.103-6; ( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by RFO 6.103-7; Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Plasmax is the only physiologically relevant cell culture medium that closely resembles the metabolic and nutritional profile of human plasma. Unlike traditional media designed to supply excessive levels of a few nutrients, Plasmax provides unmatched metabolic fidelity in a unique ready-to-use formula. This specialized cell culture media improves the metabolic fidelity of in vitro cancer cell models. The Plasmax Plasma Concentration System stands out with its autologous output, which eliminates concerns regarding pooled blood sources. This feature is crucial for patients who may have concerns about the safety of receiving blood from donor sources. The system's design ensures that the plasma concentrate is derived from the patient's own blood, providing a safer alternative to donor-based fibrin sealants that carry the risk of transmitting infectious diseases and viruses. The Plasmax Plasma Concentration System is also notable for its elevated fibrinogen concentration, which is optimal for haemostasis. This concentration is beneficial for various surgical procedures, as it enhances the effectiveness of the clotting process. The system's design allows for the production of a plasma concentrate with elevated fibrinogen, which is particularly useful in situations where a higher fibrin concentration is required for optimal healing and recovery. Overall, the Plasmax Plasma Concentration System is a unique and innovative solution for producing platelet-rich plasma (PRP) that offers several advantages, including safety, efficacy, and the ability to provide a plasma concentrate with the desired properties for various medical applications. Description of Efforts Made to ensure that offers are solicited from as many potential sources as possible (including whether a notice was or will be publicized as required by RFO Part 5 and, if not, which exception under RFO Part 5 applies): Posted a notice of intent to sole source 36C24426Q0175. This requirement was previously solicited by the Strategic Acquisition Center and there is a mandatory contract with Red One Medical LLC. (SDVOSB) 36C10G24D0040 for this item. The Contracting Officer contacted the Strategic Acquisition Center for guidance and to ensure that the bulk order and discount could be purchased through a delivery order against the mandatory contract. To receive the bulk discount the order cannot be placed against 36C10G24D0040. A separate justification to support an open market purchase order was published on January 13, 2026 and will close on January 16, 2026. Red One is the only authorized distributor of Zimmer Biomet for Plasmax, plasma kits. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable It is anticipated the unit price will be lower than the mandatory Strategic Acquisition Center contract s unit price. The price will be determined fair and reasonable through a comparison of previously awarded contract pricing. The Strategic Acquisition Center SING contract 36C10G24D0040 is not set up for bulk ordering. Red one is offering a voluntary price reduction of Zimmer Plasmax Plus kits w/30ML ACDA (SKU#800-0517) at $________offered to the facility is a ___% discount off the contract pricing. This bulk purchase agreement will save the government $___________. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: The results of the market research will be based on recent awards and on the results of this notice of intent. Any Other Facts Supporting the Use of Other than Full and Open Competition: None Listing of Sources that Expressed, in Writing, an Interest in the Acquisition: None 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: If this bulk discount is not offered an order will be placed against the mandatory Strategic Acquisition Center contract 36C10G24D0040. If the Strategic Acquisition Center contract expires market research will be conducted to ensure the government maximizes competition and a best value decision is made. 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. _____________________________ Acquisition Utilization Specialist Lebanon VA Medical Center Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. _____________________________ Andrew Taylor Contracting Officer NCO4 _____________________________ Branch Chief, Commodities 2 NCO4 VHA 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 recommend approval (if over $90 million) or approve ($900K to $90 million) for other than full and open competition. _____________________________ VHA Head of Contracting Activity (HCA) RPO East REQUEST FOR INFORMATION INSTRUCTIONS: It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above. Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, UEI Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 339112 (size standard of 1000 employees). Please answer the following questions: Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)? Is your company considered small under the NAICS code identified under this RFI? Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above? If not, can you provide additional information shown below. This is to confirm compliance with the non-manufacturer rule IAW 13 CFR 121.406(b) Nonmanufacturers. Does your company exceed 500 employees; Primarily engaged in the retail or wholesale trade and normally sells the type of item being supplied; Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice; Obtained an individual or class waiver? If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available). If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified? Must have an authorized distributor letter from the original equipment manufacture. If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to subcontracted work and completion of job. Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number. If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract? General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award. Please submit your capabilities in regard to the salient characteristics detailed above and any information pertaining to equal to items to establish capabilities for planning purposes? Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A. Please provide your UEI number. This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 12. Telephone responses will not be accepted. Responses must be received via e-mail to
[email protected] no later than, 4:00 PM Eastern Time (ET) on January 16, 2024. This notice will help the VA in determining available potential sources only. Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contracting Specialist, Andrew Taylor. Questions or responses will include the Source Sought number 36C24524Q0013 in the subject line. All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award. Any interested business concern must submit a capability statement addressing its ability to meet the requirements listed above to Capability Statement shall include a statement regarding how the business concern is engaged in wholesale trade and normally sells the item being supplied and how the business concern will take ownership of the items being delivered. Vendors shall also provide certification, evidence that they are an authorized distributor of the Original Equipment Manufacturer. If a solicitation is issued, information will be posted on the SAM web site for all qualified interested parties at a later date and interested parties must respond to the solicitation to be considered for award. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by e-mail to Contracting Officer at
[email protected] include 36C24426Q0175 in the subject line. DISCLAIMER This RFI Notice of Intent is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. End of Document