SSJ - 1.docx

Request for Sole Source Justification >SAT-SAP under RFO 12.102

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH RFO 12.102

Acquisition Plan Action ID: 36C250-27-AP-0483

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10 in support of Department of Veterans Affairs, VISN 10, John D. Dingell VA Medical Center, 4646 John R. Street, Detroit, MI 48201. 2237: 553-27-1-089-0001.

2. Nature and/or Description of the Action Being Processed: This is a request for other than full and open competition for a sole source procurement to obtain PET MRI radiopharmaceuticals in accordance with RFO 12.102 Restricting Competition and RFO 12.201-1 Simplified procedures. This action will be awarded as a new open market, firm-fixed price purchase order.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: Contractor will furnish (including packaging, transportation, manifests, and reports) all PET radiopharmaceuticals ordered from the Schedule of Supplies to the John D. Dingell VA Medical Center, 4646 John R Street, Detroit, MI 48201 for period of performance October 1, 2026, through September 30, 2027. These are PET radiopharmaceutical supplies used in Nuclear Medicine to perform exams on PET MRI patients.

The estimated value of the proposed action is $560,233.85.

Description of radiopharmaceuticals being requested:

4. Statutory Authority Permitting Restricted Competition:

RFO 12 Acquisition of Commercial Products and Commercial Services. The statutory authority for applying the Simplified Procedures for Commercial Items of RFO 12 is 41 U.S.C. § 1901 and is implemented by RFO 12.102 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 specific PET MRI radiopharmaceuticals listed in Section 3 have been determined by Detroit VAMC physicians and nuclear medicine staff to best meet the needs of the veteran population at the Detroit VAMC. Based on the market research, Sofie, Co. is currently the only vendor capable of providing all the required radiopharmaceuticals. Sofie, Co. is a small business manufacturer and distributor. It has received FDA approval for F18 Fluorodeoxyglucose (FDG), manufactures Neuraceq (F18 Florbetaben) under agreement with Piramal Imaging, manufacturers and distributes F18 PSMA (Pylarify) through a partnership with Lantheus (Progenics), and distributes Cu-64 Dotatate (Detectnet) through a partnership with Curium. Although there are other vendors that can provide some of these items, only Sofie, Co. is able to provide all four.

6. 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 sources that can meet all the Government’s requirements. There is no competition anticipated for this acquisition. An intent to sole source will be posted to SAM.gov.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: The Contracting Officer will ensure that the anticipated cost to the Government will be fair and reasonable. The Contracting Officer will make a fair and reasonable price determination based on a comparison of proposed pricing to historical prices for the radiopharmaceuticals.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Searched SBA SBS using NAICS 325412 with SD/VOSB selected and 187 results were found. Search of SBA SBS using NAICS 325412 and keyword “Radiopharmaceuticals” and 0 results were found. Search of the VA NAC Pharmaceutical Catalog resulted in existing sources for the Cu64 Dotatate (Detectnet) on contract 36F79718D0549 with Curium, LLC and the F18 Piflufolastat (Pylarify) on contract 36F79725D0093 with Progenics Pharmaceuticals, Inc. No existing contracts were found for the F18 FDG and the F18 Neuraceq.

Sources Sought email was sent out on 18 August, and responses were received from Siemens, Sofie, Co., Cardinal Health, Telix Pharma, and RLS Radiopharmacies.

Cardinal Health submitted an email confirming their interest in this opportunity but provided no documentation about their ability to perform the entire requirement. The company stated they only supply FDG and an alternate to F-18 PSMA. Cardinal Health was eliminated as a potential source.

Sofie, Co. responded indicating they are fully capable of meeting the requirement and have successfully performed for the Detroit VA during the current period of performance. Sofie, Co. stated they have received FDA approval for F18 Fluorodeoxyglucose (FDG), manufactures Neuraceq (F18 florbetaben injection) doses under agreement with Piramal Imaging, manufactures and distributes Pylarify through a partnership with Lantheus (Progenics), and distributes Detectnet through a partnership with Curium. Sofie, Co. is a small business.

Siemens responded they could supply three out of four line items, but could not offer Cu-64 Dotatate. Siemens was eliminated as a potential source.

Telix Pharma responded and only offered an alternative to F18 Plarify (No other line items listed). Telix was eliminated as a potential source.

RLS Radiopharmacies responded indicating they are capable of supplying PSMA (but didn’t specify the capability to supply PSMA Pylarify) and Dotatate, but do not have the ability to supply FDG or Neuraceq. RLS was eliminated as a potential source.

Based on the responses received to the Sources Sought notice, Sofie, Co. is the only vendor capable of supplying all of the exact radiopharmaceuticals specified by Detroit VA Nuclear Medicine.

NAICS 325412 is not on the NMR Class Waiver List. Sofie, Co., a small business, produces radiopharmaceuticals in the United States. They have no authorized distributors. The VA and SBA Rules of Two cannot be met.

The Buy American statute applies to this acquisition.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: There are no other supporting facts.

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

Siemens 810 Innovation Drive Knoxville, TN 37932

Sofie, Co.

21000 Atlantic Blvd., Suite 730 Dulles, VA 20166

Cardinal Health 414, LLC 7000 Cardinal Place Dublin, OH 43017

Telex Pharma 11700 Exit 5 Pkwy. Suite 200 Fishers, IN 46037

RLS (USA), Inc.

255 Primera Blvd.

Lake Mary, FL 32746

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: The proposed contract action is for a period of one year. After the one year, the market will be surveyed to determine if there are other sources that could lead to a competitive procurement.

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.

Administrative Officer John D. Dingell VA Medical Center

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.

Contracting Officer Network Contracting Office 10

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.

Branch Chief, Team #5 Network Contracting Office 10

Effective Date: 12/30/2025 Page 1 of 9 Revision: 02 Acquisition ID#: 36C250-27-AP-0483