JA - Part 806.3 - Over SAT - 36C257-26-AP-1108 - Redacted.pdf

VHAPG Part 806.3 OFOC Page 1 of 3 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C257-26-AP-1108

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C257-26-AP-1108

Tracker #: FY26-NCO 17-520

1. Agency: Department of Veterans Affairs (VA)

Contracting Activity: Network Contracting Office 17 (NCO-17) 5441 Babcock Rd., Ste. 302 San Antonio, TX 78240 Requesting Office: VA North Texas Health Care System

2. Nature and/or Description of the Action Being Approved:

NCO-17 intends to award a new firm-fixed price contract with Medi-Physics, Inc. for the procurement of Flyrcado™.

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

Flyrcado™ (flurpiridaz F-18) Injection, Quantity: 990 (mCi)

The VA North Texas Health Care System requires the manufacturing and delivery of Flyrcado™ (Flurpiridaz F-18), a radioactive diagnostic drug indicated for the positron emission tomography (PET) myocardial perfusion imaging (MPI) under rest or stress in patients with known or suspected coronary artery disease (CAD) to evaluate for myocardial ischemia and infarction.

Total estimated value: $378,090.90 Delivery Dates: 2/10/2026 – 2/9/2027

4. 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

VHAPG Part 806.3 OFOC Page 2 of 3

Acquisition ID#: 36C257-26-AP-1108

( ) (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;

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

GE Healthcare provided a sole source letter stating that Medi-Physics, Inc. (doing business as: GE Healthcare) is the manufacturer of Flyrcado™. Flyrcado™ is only available for purchase through GE Healthcare, with delivery from one of their radiopharmacy partners.

6. 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):

A notice of intent for sole source procurement was posted to SAM Contract Opportunities on 1/5/2026 under 36C25726Q0205. The notice stated the intent to place a contract with Medi-Physics, Inc. for the procurement of Flyrcado™. There was no response to the notice.

7. Determination by the CO that the Anticipated Cost to the Government will be

Fair and Reasonable:

The Contracting Officer anticipates the cost to the government will be fair and reasonable. Medi-Physics, Inc. typically offers their big four pricing offered in VA NAC pharmaceutical contracts.

8. Description of the Market Research Conducted and the Results, or a

Statement of the Reasons Market Research Was Not Conducted:

A search of the mandatory sources for supply procurements, UNICOR and Ability One, identified that they do not offer radiopharmaceuticals. A search in GSA Advantage did not find the requested item offered. A search in the VA NAC’s pharmaceutical catalog revealed that Flyrcado™ is only offered on GE Healthcare’s FSS contract 36F79725D0214. A search using the SBA’s Dynamic Small Business Search tool did not identify a small business that offers Flyrcado™. A notice of intent for sole source procurement to Medi-Physics, Inc. was posted to SAM Contract Opportunities for this requirement. There was no response to the notice.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

None https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-5

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Acquisition ID#: 36C257-26-AP-1108

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

None

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:

Market research will be conducted prior to subsequent procurements to identify if there has been any change in the marketplace.

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.

//SIGNED// 1/21/2026

Redacted Date:

Chief Technologist, Nuclear Medicine VA North Texas Health Care System

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

//SIGNED// 1/21/2026

Contracting Officer

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

//SIGNED// 1/22/2026

Branch Chief, Patient Administrative Support Network Contracting Office 17 https://dvagov.sharepoint.com/sites/vhapromanual/SitePages/VHAPM-Part-806.3.aspx