36C24626Q0030.docx

Attachment 1: Request for Sole Source Justification Format >SAT

GENERAL INFORMATION

CONTRACTING OFFICE ADDRESS

Department of Veterans Affairs Network Contracting Office 6 100 Emancipation Drive Hampton VA 23667

POINT OF CONTACT*

Contracting Officer James Risbon james.risbon@va.gov 757-728-7128

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

DESCRIPTION

NOTICE OF INTENT TO SOLE SOURCE:

The Department of Veterans Affairs Network Contracting Office 6 intends to award a sole source, firm-fixed-price, contract to Blue Ridge Isotopes, Inc. for the purchase of Radiopharmaceutical Isotopes for delivery to the Salem VA Medical Center Radiology Department located at 1970 Roanoke BLVD, Salem VA 24153.

This contract action is for products and services for which the Government intends to solicit from only one source under the authority of FAR 6.302-1 (Only One Source). Interested parties may identify their interest and capability to respond to the requirement or submit proposals. The North American Industry Classification System (NAICS) for this requirement is 325412 (Pharmaceutical Preparation Manufacturing) with a small business size standard of 1300 Employees.

THIS NOTICE OF INTENT IS NOT A REQUEST FOR COMPETITIVE QUOTATIONS

The Department of Veterans Affairs, Hampton VA Medical Center intends to award a firm fixed price, single source, base plus 4 option year contract to Blue Ridge Isotopes, Inc. The purpose of the order is to obtain Radiopharmaceutical Isotopes to be used by the facility Radiology Department for Nuclear Medicine Imaging and Procedures. All deliveries must be made within a 2 hour or less delivery time frame due to the short shelf life of the isotopes.

Base plus 4 Option Year Period of Performance:

Base Year: 10-01-2025 to 09-30-2026 Option Year 1: 10-01-2026 to 09-30-2027 Option Year 2: 10-01-2027 to 09-30-2028 Option Year 3: 10-01-2028 to 09-30-2029 Option Year 4: 10-01-2029 to 09-30-2030

A decision by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purpose of determining whether to conduct competitive procurement. The Government will not be responsible for any costs associated with the preparation of responses to this notification. All inquiries and submittals must be sent via email to James Risbon, Contract Specialist, at James.Risbon@va.gov NLT 09-19-2025 at 1:00 PM EDT. Telephone inquiries will not be accepted.

Special Notice Special Notice

Special Notice

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C246-25-AP-2497

1. Contracting Activity: Department of Veterans Affairs, Network Contractring Office 06. Loatced at 100 Emancipation Drive, Hampton VA, 23667.

Purchse Request : 658-26-1-046-0002

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

The proposed acquisition is for firm fixed price order for radiopharmaceuticals for VAMC Salem via other than full and open competition citing Only One Awardee Capable FAR6.302-1 The products are supplied by more than one supplier, the delivery is not possible due to the distance of delivery for other vendors. The products are time sensitive once mixed the life cycle is critical. The radioactive labeled cells and material leukocyte must be returned VAMC Salem within 1 hour of the labeling process. The closest vendor approximately five miles away, is Blue Ridge Isotopes at 1630 Midland Rd, Salem, VA is the only vendor that can perform to the standard of the statement of work. Blue Ridge Isotopes is the only vendor that is geographically close enough to make the required 2 hour isotope shelf life delivery time frame.

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

The proposed acquisition is to provide radiopharmaceutical Isotopes for the Salem VA Medical Center Radiology department for nuclear medicine imaging and procedures. This acquisition is for a base plus 4 option year contract to be awarded on 10-01-2025. The schedule of items includes single dose containers and multi-dose vials of multiple radiopharmaceuticals. The estimated value for the base plus 4 option year contract is $2,025,298.91. This estimate is based on historical use data.

Base plus 4 Option Year Period of Performance:

Base Year: 10-01-2025 to 09-30-2026 Option Year 1: 10-01-2026 to 09-30-2027 Option Year 2: 10-01-2027 to 09-30-2028 Option Year 3: 10-01-2028 to 09-30-2029 Option Year 4: 10-01-2029 to 09-30-2030

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

FAR 6.302-1;

6.302-4

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 unique qualification of Blue Ridge Isotopes is their gegraphic location they are located 5 miles from the Salem VA Medical Center. No other vendor can meet the delivery time necessary to supply the products needed by the government for daily use, the time frame for emergency delivery is much shorter. The short delivery time is justified and consistent in the market place based on the shelf life of the medication.

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

A search of NAC, FPDS,SCMC, DSBS and GSA sites all revealed that the majority of radiopharmaceutical requirements have been placed as a direct open market acquisition or against an existing Indefinite Delivery Contracts (IDC).

An internet search for Radiopharmaceutical Companies in the states of Viginia, North Carolina and Tennessee was conduct on 09-15-2025 to identify if there where any companies geographically close enough to the Salem VA Medical Center that could meet the required delivery time frame. No vendor/vendors were found that could meet the required delivery time frame.

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

Fair and reasonable price will be determined by comparison to historical costs paid throughout NCO6 for identical line items by comparing line by line price comparison to the price quoted by the vendor. The Contracting Officer anticipates cost will be fair and reasonable based on FAR 13.106-3(a)(2)(ii).

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

Historical data shows that the radiopharmaceutical requirements for the past 5 years have been awarded to Blue Ridge Isotopes (see below) due to their geographical local of being 5 miles form the Salem VA Medical Center.

FY 21 658C10068 / Blue Ridge Isotopes / Radiopharmaceuticals FY 22 658C20041 / Blue Ridge Isotopes / Radiopharmaceuticals FY 23 658C30026 / Blue Ridge Isotopes / Radiopharmaceuticals FY 24 658C40017 / Blue Ridge Isotopes / Radiopharmaceuticals FY 25 658C50015 / Blue Ridge Isotopes / Radiopharmaceuticals

Due to the short life span of the radiopharmaceutical isotopes, further research was conducted by doing an internet search for “Radiopharmaceutical Companies” in the states of Viginia, North Carolina and Tenneessee. The CO could not find any other radiopharmaceutical vendors that could meet the required delivery time frame due to their geographical locations.

Bases on the market research above CO does not anticipate on receiving a quote from any other vendor than Blue Ridge Isotopesthe can make a deliver within the required sensitive time frame. The CO believes that it is in the best interest of the government to award this requirement directly to Blue Ridge Isotopes IAW FAR 6.302-1 to satisfy the program need date.

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:

At this time, there are no actions that may be taken to overcome any barriers to competition. The Contracting Officer will continue to monitor the market for new vendors.

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.

Administrative Officer Sallem, VAMC

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.

Contracting Officer Supply/Service 1

NCO6

Brancg Chief, Supply/Service 1

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.

Division 1

VHAPG Part 806.3 OFOC Page 7 of 7 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: __________________