JA FAR 13.5 Sole Source F18 FDG Iowa City VA_signed.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Request for Sole Source Justification >SAT-$7.5M under FAR13.5

Effective Date: 11/15/24 Page 1 of 3

REVISION: 01

Acquisition ID#: 36C263-26-AP-0694

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C263-26-AP-0694

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 23, 1303 5th St.

Suite 300, Coralville, IA 52241.

Organizational Activity: Iowa City VA Health Care System, 601 Highway 6 West, Iowa City, IA 52246-

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

The procurement is for F-18 FDG (Fludeoxyglucose) radioactive tracer doses in accordance with FAR

13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentaion Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. This action will result in the award of a new firm-fixed-price contract.

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

The Iowa City VA Healthcare System requires a contract for F-18 FDG radioactive tracer doses used with PET Scans to diagnose certain types of cancer. The radioactive doses must be produced within a 2-hour drive time from the Iowa City VA because their half-life is 110 minutes, just under two hours. The contractor must be able to produce and deliver last-minute and emergency orders and provide extra doses if delivery is delayed because more is required when doses are weakened over time. The contract will be firm fixed-price, Base Year with four Option Years. The contractor shall have the proper Pharmaceutical and Board of Health licenses which include radioactive material.

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.

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 sole source contractor, Hot Shots Nuclear Medicine, LLC (Hot Shots NM, LLC) located in Davenport, Iowa, is the only source that produces the radioactive tracer doses within a two-hour drive from the Iowa City VA. The half-life of the radioactive doses prevents other sources who are located beyond the two-hour drive requirement from participating. Additionally, they are able to

Effective Date: 11/15/24 Page 2 of 3

Acquisition ID#: 36C263-26-AP-0694 produce doses for last minute “add-ons” and emergency orders. They meet all the licensure requirements.

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

-An Intent to Sole Source was posted to SAM.gov from 10/29/25 to 11/10/25 which produced one response from Hot Shots NM, LLC restating their interest in fulfilling our requirement.

-SBA Dynamic Small Business Search was searched for Veteran Owned Small Businesses and Service- Disabled Veteran Owned Small Businesses.

-The VA National Acquisition Center Schedule was searched.

-The VA Strategic Acquisition Center Schedule was searched.

-GSA was searched.

-The Iowa Board of Health was contacted and a request for a listing of Radiopharmacies in Iowa was made upon their office but was denied for proprietary reasons.

-The websites of prominent national radiopharmaceutical companies were searched using their digital location finder tools and no sources could be located within the required two-hour drive.

-Online research was conducted.

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

Reasonable: The Contracting Officer anticipates the cost to be fair and reasonable and cost comparisons with similar contracts in other regions of the VA will be used.

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

Market Research Was Not Conducted:

As mentioned above:

-An Intent to Sole Source was posted to SAM.gov from 10/29/25 to 11/10/25 which produced one response from Hot Shots NM, LLC restating their interest in fulfilling our requirement.

-SBA Dynamic Small Business Search was searched for Veteran Owned Small Businesses and Service- Disabled Veteran Owned Small Businesses.

-The VA National Acquisition Center Schedule was searched.

-The VA Strategic Acquisition Center Schedule was searched.

-GSA was searched.

-The Iowa Board of Health was contacted and a request for a listing of Radiopharmacies in Iowa was made upon their office but was denied for proprietary reasons.

-The websites of prominent national radiopharmaceutical companies were searched using their digital location finder tools and no sources could be located within the required two-hour drive.

-Online research was conducted.

Additionally, the supplies provided by Hot Shot NM, LLC are compliant with the Buy American Statute; they are produced in Davenport, Iowa.

Veteran owned small business sources were not located.

Effective Date: 11/15/24 Page 3 of 3

Acquisition ID#: 36C263-26-AP-0694

The last contract awarded for this requirement was reviewed. It was awarded to the same vendor using sole source procedures because the market research led to the same conclusions.

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

None currently.

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

-Hot Shots Nuclear Medicine, LLC., Davenport, Iowa

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:

This office will continue to monitor the market for the arrival of new radiopharmacies within the two-hour drive of the Iowa City VA Healthcare System.

12. 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.

Joseph Bennett Date Contract Officer Service Supply Team 2 Network Contracting Officer 23

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Curt LaRose Date Branch Chief Service Supply Team 2

Network Contracting Office 23

JOSEPH

BENNETT

Digitally signed by

JOSEPH BENNETT

Date: 2025.11.20 20:52:51 -06'00'

11/21/25

11/20/25

CURT

LAROSE

Digitally signed by CURT

LAROSE

Date: 2025.11.21 06:46:59 -06'00'