6505--PET MRI Radiopharmaceuticals 36C25025Q0891

INTENT TO SOLE SOURCE The Department of Veterans Affairs, VHA Regional Procurement Office Central, Network Contracting Office 10, intends to enter into a sole source procurement for PET MRI Radiopharmaceuticals for the John D. Dingell VA Medical Center, 4646 John R Street, Detroit, MI 48201. The Department of Veterans Affairs intends to award a sole source, firm-fixed price, 1-year purchase order to Sofie Co., 21000 Atlantic Blvd., Suite 730, Dulles, VA 20166. The associated North American Industry Classification System (NAICS) Code is 325412 Pharmaceutical Preparation Manufacturing, and the Business Size Standard is 1,300 employees. The contractor will furnish (including packaging, transportation, manifests, and reports) all PET radiopharmaceuticals listed below to the John D. Dingell VA Medical Center, 4646 John R Street, Detroit, MI 48201 for period of performance October 1, 2025, through September 30, 2026. These are PET radiopharmaceutical supplies used in Nuclear Medicine to perform exams on PET MRI patients. Product Name UoM Est. Annual Quantity Cu-64 Dotatate (Detectnet) 3-5 mCi Dose 25 F18 PSMA (Pylarify) 8-10 mCi Dose 70 F18 Fluorodeoxyglucose (FDG) 8-10 mCi Dose 908 F18 Neuraceq 8-10 mCi Dose 52 It is the Government s belief that Sofie Co. is the only vendor capable of providing all of these specific radiopharmaceuticals for the Detroit VA. Sources sought notice 36C25025Q0852 was published on Contract Opportunities from August 18, 2025 through August 22, 2025. Responses were received from five contractors, including Sofie Co. Contractor capabilities were reviewed, and although the other contractors could provide some of the required products, Sofie Co. was the only contractor capable of providing all of these specific radiopharmaceuticals required by Detroit VA Nuclear Medicine. This notice satisfies the requirement at FAR 5.201(b)(1) to publicize the proposed contract action. This notice of intent is not a request for competitive proposals or quotes. Interested parties may identify their interest and capability to respond to the requirement. A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. Interested persons may identify their interests and capability to respond to this requirement no later than 5:00 PM Eastern Time, Tuesday, September 2, 2025. Any response to this notice must show clear and convincing evidence that competition would be advantageous to the Government. Supporting evidence must be furnished in sufficient detail to demonstrate the ability to meet the subject requirement. This information shall be provided at no cost or obligation to the Government. Interest/capability statements shall be submitted to Jeffrey Rozema, Contracting Officer, via e-mail at jeffrey.rozema@va.gov. Telephone inquiries will not be accepted.

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5 Effective Date: 11/15/24 Page 1 of 9 REVISION: 01 Acquisition ID#: 36C250-25-AP-2180 DEPARTMENT OF VETERANS AFFAIRS SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5 Acquisition Plan Action ID: 36C250-25-AP-2180 Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10, in support of VISN 10, John D. Dingell VA Medical Center, Pathology & Medicine Services, located at 4646 John R Street, Detroit, MI 48201 2237: 553-26-1-059-0004 Nature and/or Description of the Action Being Processed: This procurement is for various blood, blood products, and specialized reference laboratory testing services for the veteran patients at the John D. Dingell VA Medical Center, Pathology & Medicine Services, in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. A sole source procurement is being conducted for these products and services. The action will be awarded as a new open market, firm-fixed price, 5-year ordering period IDIQ contract. Description of Supplies/Services Required to Meet the Agency s Needs: The products and services provided will vary based upon orders specified by the clinicians. The contractor shall provide blood, blood products, and specialized reference laboratory testing services on an as-needed and on-demand basis, 24 hours a day, 7 days a week, 365 days a year. The total estimated contract value for all five years is $2,305,387.02 in accordance with the Independent Government Estimate as developed from historical ordering quantities, future demand projections, and market research pricing quote from The American National Red Cross. The contract period of performance is anticipated to be October 1, 2025 through September 30, 2030. 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 Demonstration that the Contractor s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): Previous procurement history and current market research show there are two potential providers of blood, blood products, and reference laboratory testing services in the service area of the John D. Dingell VA Medical Center The American National Red Cross and Versiti Michigan, Inc. Versiti Michigan, Inc. was contacted by the Detroit VAMC blood bank lab; the company responded saying they have made commitments to their current and new clients transitioning to Versiti, and they are not in a position to add the John D. Dingell VAMC to their participating partners at this time. Historically, Versiti also will not allow for blood and blood products to be re-distributed between local hospitals for credit, which would ultimately increase costs to the VA up to $10K per year based on current re-distribution volumes and pricing. The American National Red Cross has been the sole and exclusive vendor for blood products and reference testing services for this facility for many years. Their proximity to the John D. Dingell VA Medical Center s current location provides rapid turn around for both blood products and service requests and makes courier services more cost-effective. The American National Red Cross maintains files of our existing patients which have been previously sent there for difficult cross-matches, enabling future blood product needs to be met more quickly. Additionally, all current blood banking procedures would have to be re-validated and re-written if a different provider was chosen. Lastly, all current employees, both laboratory and clinical staff, would have to be re-educated on the changes in ordering, specimen collection, transportation, and billing. These changes could potentiallyly increase the likelihood of delays and/or testing errors which could negatively impact patient care. Therefore, for the reasons stated above, a sole source procurement with The American National Red Cross is in the best interests of the John D. Dingell VA Medical Center and its mission. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional responsible sources that can meet the Government s requirements. There is no competition anticipated for this acquisition. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer will utilize the price analysis techniques in FAR 13.106-3(a)(2) to determine the prices to be fair and reasonable. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Search of VetCert using NAICS 621991 resulted in 61 potential SDVOSB/VOSB s. Search of DSBS for certified SDVOSB/VOSB s using NAICS 621991 and keyword Blood resulted in zero concerns. A second DSBS search for all small businesses in Michigan also resulted in zero concerns. There are no existing VA or other Government agency contracts from which to source the required blood products. There are only two suppliers of blood and blood products in the Detroit, Michigan service area, The American National Red Cross and Versiti Michigan, Inc. Both companies are other than small business. The American National Red Cross has always serviced the Detroit VAMC as historically it has been the only company capable of meeting all the requirements of the VAMC Detroit blood bank lab. Past performance of The American National Red Cross has always been satisfactory or higher. Versiti Michigan, Inc., as noted in Section V above, is not in a position to service the John D. Dingell VAMC at this time. Neither the VA Rule or Two nor the SBA Rule of Two can be met. 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: The American National Red Cross 431 18th St Washington, DC 20006 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 proposed contract action is for a period of five years. After the five years, the market will be surveyed to determine if there are other sources that could lead to a competitive procurement. 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.