P03 GSA_FSS_Sole_Source_Justification_OVER_SAT AP-0322s_Redacted.pdf

VHAPG Part 808.405-6 Limiting Sources Page 1 of 4 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C261-27-AP-0322

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

GSAM Subpart 538.71— Federal Supply Schedule Ordering Procedures

Acquisition Plan Action ID: 36C261-27-AP-0322 JOFOC Tracker Log Number: FY27 - NCO 21 - 47

(1) Contracting Activity: Department of Veterans Affairs (VA), Regional Procurement Office West (RPOW), Veterans Integrated Service Network (VISN) 5, Health Service Area (HSA) 5.2, Network Contracting Office (NCO) 21, VA Northern California Health Care System (VANCHCS).

PR 2237: 612-27-1-116-0007

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). The action being reviewed and approved is a new requirement for a sole source task order with Bracco Diagnostics, Inc., a Large Business.

Order against: FSS Contract Number: 36F79718D0501

Name of Proposed Contractor: Bracco Diagnostics, Inc.

Street Address: 510 Carnegie CTR STE 300

City, State, Zip: Princeton, NJ 08540-6905

Phone: (609) 514-2448

(3) Description of Supplies or Services:

The total estimated value of the proposed action is $653,800.38, consisting of a one-year base period and one (1) one-year option period.

The period of performance would be:

Base Year 10/01/2026 – 09/30/2027 $326,900.19

Option Year 1 10/01/2027 – 09/30/2028 $326,900.19

The Sacramento VA Medical Center requires Bracco Cardiogen Rubidium products, specifically Rubidium-82 (Rb-82) generators and the associated radiopharmaceutical Cardiogen Rubidium, to support cardiac PET imaging operations. This procurement is for a firm-fixed-price task order to acquire Rubidium (Rb-82) generators and associated radiopharmaceutical supplies for VA

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Acquisition ID#: 36C261-27-AP-0322

Northern California Health Care System (VANCHCS). These Rubidium generator systems are essential for establishing and supporting cardiac PET diagnostic services and must be fully compatible with VANCHCS’s existing imaging infrastructure, software platforms, and network systems.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

GSAM 538.7104-3(b)(1)(i): The need is of such unusual urgency that following the procedures would result in unacceptable delays in fulfilling that need:

GSAM 538.7104-3(b)(1)(ii): Only one source is capable of providing the products, services, or solution required at the level of quality required because the products, services, or solutions are unique or highly specialized:

Market research confirms that Bracco Diagnostics Inc. is the only source capable of providing the required Rubidium-82 (Rb-82) generators and the associated radiopharmaceutical Cardiogen Rubidium at the level of quality and reliability necessary to support cardiac PET imaging operations for the Sacramento VA Medical Center, a facility within the VA Northern California Health Care System (VANCHCS). Bracco Diagnostics Inc. is the sole manufacturer and authorized supplier of Cardiogen Rubidium, and these products are unique and highly specialized, with no clinically acceptable or technically compatible alternatives available from other vendors. The Rb-82 generator system and Cardiogen Rubidium radiopharmaceutical must integrate with existing imaging platforms, clinical workflows, and network infrastructure across VANCHCS, and only Bracco Diagnostics can provide products that meet these requirements.

Additionally, Bracco maintains exclusive control over production, quality assurance, distribution, and technical support for Cardiogen Rubidium, establishing it as the only qualified provider capable of meeting VANCHCS’s operational, safety, and performance needs. Because the products and services required are unique, highly specialized, and can only be supplied and supported by the original equipment manufacturer, Bracco Diagnostics Inc. is the only source capable of meeting the Government’s needs at the necessary level of quality, satisfying GSAM 538.7104-3(b)(1)(ii).

GSAM 538.7104-3(b)(iii): The order should be issued on a sole source basis in the interest of economy and efficiency because it is a logical follow-on to an FSS order already issued on a competitive basis:

GSAM 538.7104-3(b)(iv): It is necessary to place the order with a particular FSS contractor to satisfy a minimum guarantee established in the FSS BPA:

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Acquisition ID#: 36C261-27-AP-0322

GSAM 538.7104-3(b)(v): A law expressly authorizes or requires that the purchase be made from a specified source:

(5) Describe Why You Believe the Order Represents the Best Value consistent with GSAM 538.7102-2(b)(4) to aid the contracting officer in making this best value determination:

By placing an order against a schedule contract, the ordering activity has concluded that the order represents the best value. Although General Services Administration has already negotiated fair and reasonable pricing, the Contracting Officer will seek an additional discount before awarding the order.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

A Notice of Intent to Sole Source for solicitation 36C26127Q0032 was posted on Contracting Opportunities on August 26, 2026, and closed on September 9, 2026. No valid responses were received.

Market Research indicates that Rb82 generator and the infusion system requirements at multiple VA facilities have been sole-sources to Bracco Diagnostics Inc. Relevant awards include:

• 36C24126F0008 – West Haven VAMC

• 36C24821N0017 – VA Orlando Medical Center

• 36C26026F0306 – VA Portland Medical Center

A search of the Small Business Administration’s (SBA) Dynamic Small Business Search (DSBS) database on September 8, 2026, using the North American Industry Classification System (NAICS) code 325412 Pharmaceutical Preparation Manufacturing identified 180 Service- Disabled Veteran Owned Small Businesses (SDVOSBs) and 187 Veteran Owned Small Businesses (VOSBs).

Only one company, Bracco Diagnostics, Inc., manufactures the required Cardiogen Rubidium radiopharmaceuticals. This product is available exclusively through the National Acquisition Center Pharmaceutical Catalog under Contract 36F79718D0501. A search of the NAC using the trade name “Cardiogen Rubidium” identified this single contract, 36F79718D0501, as the sole source.

No other vendors, distributors, or alternative contracts were identified that supply Cardiogen Rubidium. The market contains no competing products that meet the clinical and technical requirements for Rb-82 cardiac PET radiopharmaceuticals.

(7) Any Other Facts Supporting Justification: There are no other facts.