36C257-26-AP-0992-FY26-1695 JOFOC NCO17 Flyrcado - HCA Approved -.pdf

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C257-26-AP-0992

Tracker #: FY26-NCO 17-525

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: South Texas Veterans Health Care System

Purchase Request #: 671-26-1-029-0010

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™. The contract will have five (5) one-year ordering periods.

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

Flyrcado™ (flurpiridaz F-18) Injection, Estimated annual quantity: 675 (mCi) The South Texas Veterans 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, including all five (5) ordering periods: $1,288,946.25 Delivery Dates: 3/2/2026 – 3/1/2031

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

( ) (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 dated July 9, 2025, 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. Accordingly, Medi-Physics, Inc. is the only firm capable of providing the supplies described in section 3 above without the Veteran’s Health Administration experiencing substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays in fulfilling its requirements.

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 1/6/2026 under 36C25726Q0205. The notice stated the intent to place a contract with Medi-Physics, Inc. for the procurement of Flyrcado™. In addition, the notice stated that all responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The response date of 1/12/2026 has passed and 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. It is anticipated that Medi-Physics, Inc. will offer their big four pricing (unit price: $381.91) offered in VA NAC pharmaceutical contract 36F79725D0214.

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

Statement of the Reasons Market Research Was Not Conducted:

Market research was conducted pursuant to RFO part 10 and VAAR 810.001-70 8/29/2025 through 1/14/2026. 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. The Buy American Act is applicable to this procurement; radiopharmaceuticals are manufactured in the US. Radiopharmaceutical providers must hold a current license with the US Nuclear Regulatory Commission (USNRC), or a State with a formal agreement with the USNRC that allows the State to regulate radioactive materials.

A search using the SBA’s Dynamic Small Business Search tool did not identify any 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. As described in section 6 above, in accordance with RFO part 10, market research was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties.

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

None

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 processing annual delivery orders and on 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.

Willie J. Clark, Jr. Date:

Supervisor, Nuclear Medicine South Texas Veterans Health Care System

WILLIE CLARK Digitally signed by WILLIE CLARK Date: 2026.02.17 11:01:22 -06'00'

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.

Vance W. Farrell Date:

Contracting Officer

b. One Level Above the Contracting Officer: I certify the justification meets requirements for other than full and open competition.

Sandra M. Norton Date:

Branch Chief, Patient Administrative Support Network Contracting Office 17

Director of Contracting: I certify the justification meets requirements for other than full and open competition.

Mark A. Layman Date:

Director of Contracting Network Contracting Office 17

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($900K to $90 million) for other than full and open competition.

Curtis M. Jordan Date:

Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA)

VANCE FARRELL Digitally signed by VANCE FARRELL Date: 2026.02.17 11:17:23 -06'00'

SANDRA NORTON

Digitally signed by SANDRA

NORTON

Date: 2026.02.18 08:10:25 -06'00'

MARK LAYMAN Digitally signed by MARK LAYMAN Date: 2026.02.19 07:22:30 -06'00'

CURTIS JORDAN Digitally signed by CURTIS JORDAN Date: 2026.02.21 10:25:57 -07'00'