JA_Redacted.pdf

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Radiopharmaceuticals
Solicitation number
36C25625AP4141
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This document is a Justification and Approval (J&A) for Other Than Full and Open Competition (>SAT) for the Department of Veterans Affairs, Southeast Louisiana Veterans Health Care System. The procurement is for radiopharmaceutical support for diagnostic imaging services, with an estimated value of $926,170.28 for a performance period from August 1, 2025 to November 30, 2025. The radiopharmaceuticals are critical for nuclear medicine exams and treatment options, particularly for cancer diagnosis and treatment, and will be used to produce images of organs and tissues using scintigraphy.

The procurement is being pursued as an emergency order due to the previous Federal Supply Schedule contract no longer being available. The document emphasizes the unique nature of these radiopharmaceuticals, which can only be dispensed by an authorized nuclear pharmacist with an active Nuclear Regulatory Commission license. The justification cites "Unusual and Compelling Urgency" as the statutory authority for other than full and open competition, and market research yielded no other contractors capable of fulfilling the requirement within the specified timeframe. The VA intends to continue conducting market research to potentially enable future competitive acquisitions.

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Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 4 Revision: 03 Effective Date: 04/15/24 Acquisition ID#:

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID:

Contracting Activity: Department of Veterans Affairs, NCO 16, Southeast Louisiana Veterans Health Care System

Nature and/or Description of the Action Being Processed:

The Nuclear Medicine Section of Diagnostic Imaging Service provides a unique service in that it provides information that is often unattainable using other imaging procedures. The information includes details on the function and anatomy of the body structures using radioactive materials injected into the body. The nuclear medicine supplies (the radioisotopes) are the most viable option for diagnostic imaging and/or radiotherapy treatment and information for many diseases of the organs, as well as treatments of pathological conditions, particularly cancer.

The radiopharmaceuticals were previously procured through an FSS contract but are now no longer available for purchase through this specific contract. This is a new firm-fixed price requirement for an emergency order as a follow on action for these supplies to continue with no further delays.

Description of Supplies/Services Required to Meet the Agency’s Needs:

Radiopharmaceutical support for diagnostic imaging services produc images of organs and tissues using a process called scintigraphy. The estimated value of the proposed action is $926,170.28 for a period of performance August 1, 2025 – November 30, 2025. The Radiopharmaceuticals delivered will be used in the administration of radioisotopes to support and aid in the diagnosis and treatment of various disease processes. Radioisotopes are an essential part of the medical diagnostic procedures that can study the dynamic processes taking place in various parts of the body. The radiation give visualization and trace the radioisotope agent s path through the body. onitor a disease or a manifestation of a disease in humans that exhibit spontaneous disintegration of unstable nuclei with the emission of nuclear particles or photons. Radionuclides are an essential part of the medical diagnostic procedures that can study the dynamic processes taking place in various parts of the body.

Statutory Authority Permitting Other than Full and Open Competition:

( ) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy

Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

(X) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR

6.302-2;

Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 2 of 4 Revision: 03 Effective Date: 04/15/24 Acquisition ID#:

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4 ( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR

6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Due to the nature of these specialized radiopharmaceuticals and the need to avoid unacceptable delays of these highly specialized supplies an emergency procurement must be made to fulfill the agency’s requirement. The materials in the mediations are radioactive, they can only be dispensed by an authorized nuclear pharmacist with an active material program license issued by the Nuclear Regulatory Commission (NRC). This procurement is for the safe delivery of required nuclear radiopharmaceuticals that will be used in the performance of nuclear medicine exams and as treatment options as required by patient’s providers in the diagnosis and treatment of various disease processes in our veteran patients to include cancer.

Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

The proposed action will not be synopsized due to the agency’s urgent need for the supplies and any delays in award of a contract would result in serious injury, financial, or other to the Govern nt. There is only one known vendor that can provide the highly specialized radiopharmaceuticals to the medical center without causing any delays. According to FAR 5.202(a)(2) “the proposed contract action is made under the conditions described in 6.302-2 and the Government would be seriously injured if the agency complies with the time periods specified in 5.203”.

Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

The anticipated cost will be considered fair and reasonable in accordance with FAR 13.106-3(a)(2)(i) market research and FAR 13.106-3(a)(2)(ii) comparison of the proposed price with prices found reasonable on previous purchases and competition.

Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Market Research yielded no other contractors capable of fulfilling the requirement of this contract within the specified timeframe. Due to the urgent and compelling nature of this requirement a solicitation was not feasible.

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

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