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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

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.

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.

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:

Product Name
UoM
Est. Annual Quantity
Cu-64 Dotatate (Detectnet) 3-5 mCi
Dose
F18 PSMA (Pylarify) 8-10 mCi
Dose
F18 Fluorodeoxyglucose (FDG) 8-10 mCi
Dose
F18 Neuraceq 8-10 mCi
Dose
F18 PSMA (Pylarify) Cancellation Fee
Each

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

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.