INTENT TO SOLE SOURCE
The Department of Veterans Affairs, Network Contracting Office 4 (NCO4) intends to sole source a consolidated contract for Ga-68 Illucix and Ga-68 Netspot Radiopharmaceuticals for the VA Pittsburgh Healthcare System and Lebanon VA Medical Center. All work is to be completed in accordance with statement of work. This sole source contract will be solicited and negotiated with Cardinal Health,414, LLC 7000 Cardinal Place, Dublin, Ohio 43017, under the authority of RFO 6.104-1 F&R Determination.
See attached Draft Statement of Work (SOW).
The North American Industry Classification System (NAICS) code for this procurement is 325412. The Small Business Administration (SBA) standard is 1300.
Interested vendors that can meet this requirement shall identify their interest and capability, and respond to this notice by 08/14/2026 by 10:00 AM EST. Interested vendors must send a capability statement, no more than one page in length; to include Company Name, ueiSAM Number, Socioeconomic Category, brief description of your business entities capability to handle this project at Lebanon and Pittsburgh VA Medical Centers.
This Special Notice of Intent to Sole Source is for planning purposes only. No solicitation will be made available. This is NOT a request for quotations. All information shall be provided at no cost or obligation to the Government. Responses must be sent via email to the Contracting Specialist at christa.stine@va.gov.
Responses received will be evaluated; however, a determination by the Government not to compete the proposed procurement based upon the responses to this notice is solely at the discretion of the Government. If no responses are received, Contracting will proceed with the sole source negotiation with Cardinal Health, 414, LLC.
STATEMENT OF WORK (SOW)
Title of Project: Illucix (Gallium 68 PSMA-11) and NETSPOT (Ga-68 Dotatate) for Lebanon and Pittsburgh VA Medical Centers Nuclear Medicine Program.
Scope of Work: The contractor shall provide timely delivery of name brand only radiopharmaceuticals in the form of Illucix (Gallium 68 PSMA-11) and NETSPOT (Ga-68 Dotatate) to Lebanon and Pittsburgh VA Medical Centers as defined in this statement of need. The distributor must be located within the 68 minute half-life of the Radiopharmaceutical to each facility.
Background: Lebanon and Pittsburgh VA Medical Centers have a need to establish a contract for delivery and inventory management of name brand only radiopharmaceutical, Illucix (Gallium 68 PSMA-11) and NETSPOT (Ga-68 Dotatate) for their Nuclear Medicine program. Contractors who supply products from non-High Enriched Uranium sources (non-HEU) are preferred. Illucix is an advanced radioactive PET imaging tracer that is designed to help detect the presence of prostate-specific membrane antigen (PSMA) cancer cells in the body.
Type of Contract: Firm-fixed priced, Indefinite Delivery, Indefinite Quantity (IDIQ) contract.
Sole Source: Cardinal Health is the only distributor within the 68 minute half-life of the Radiopharmaceutical to each Lebanon and Pittsburgh VA Medical Centers.
Period of performance: The government is requesting a period of performance beginning October 1, 2026, through September 30, 2031.
General Requirements:
1. Contractor shall be able to provide an adequate supply of product to meet the requirements of the Lebanon and Pittsburgh VA Medical Centers.
2. Contractor shall provide a barcode labeled insert to allow scanning data into existing nuclear medicine information management system (NMIS) or other dose tracking system. Contractor product barcode system shall be compatible with Nuclear Medicine Information Systems (NMIS) in general.
3. Contractor shall hold a current unrevoked NRC and/or agreement state radioactive materials license, which in addition to other license conditions, would allow for the receipt and disposal of radioactive material, and FDA license to produce and distribute radiopharmaceuticals for human administration, and be able to provide a copy of their radioactive material license with their proposal.
4. Contractor shall immediately notify the Contracting Officer and Contracting Officer Representative, upon any action by the NRC or an agreement state and/or FDA to suspend or modify the radioactive materials license.
5. Contractor shall meet all Nuclear Regulatory Commission (NRC), Department of Transportation, FDA, OSHA and all other agency rules and regulations (Federal and State), and must maintain all applicable certifications throughout the performance of contract.
6. Contractor shall provide evidence of special driver s licenses (competency) due to transporting hazardous materials. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, F.D.A., OSHA and all other agency rules and regulations (Federal and State).
7. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies prior to shipment. Contractor shall test all products for Quality Control at an agreed upon frequency and only those products that pass QC measurements may be sent to the VA. This testing shall be performed at no cost to the VA. The contractor will provide a detailed description of the test upon request.
8. Contractor shall pick up scheduled items, used and unused, for proper disposal at no cost to the Government.
9.Contractor shall accept returns for credit under the following conditions:
Product(s) shipped in error.
Product(s) damaged in shipment
Concealed shipping damages
Recalled product(s)
Outdated products in unopened, original container (specifically authorized for return by manufacturer).
10. Contractor/supplier shall abide by (CFR 10) Title Code of Federal Regulations, which states: A Licensee may use for medical use only:
a. By-product material manufactured, labeled, packaged, and distributed in accordance with a license issued pursuant to the regulations in Title 10, Code of Federal Regulations, Part 35 and the equivalent regulations of an Agreement State.
b. Reagent kits that have been manufactured, labeled, packed and distributed in accordance with the approval by the Commission pursuant to S32.73 or an Agreement State under equivalent regulations for the preparation of radiopharmaceuticals for medical use.
11. Contractor must adhere to the provisions of Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI) as required by complying with rules governing the security, use and disclosure of protected health information by covered entities, including the Department of Veteran Affairs.
12. Any proposed substitution of product shall have the written approval of the VA Nuclear Medicine Service and the Contracting Officer or his/her designee.
13. Any defective or inferior products shall be replaced within the timeline specified at no cost to the VA. This includes damage during transit and will be the responsibility of the contractor to contact the POC and contracting officer within 24 hours after loss or damage of materials known by the contractor. The contractor shall be responsible for initiating action to replace all damaged or missing material at no additional cost to the government.
14. All radiopharmaceuticals shall be delivered in ready-to-use unit dose form in lead shield containers and plastic shrink wrap fitted at union of the container cap and base to ensure untampered seal. Product information must include supplier s source of radiopharmaceuticals, package inserts, results of quality control testing performed by supplier and copies of supplier s license at no additional cost.
15. All radiopharmaceuticals shall be calibrated and labeled with the patients name, concentration, calibration, time, total volume, total activity, lot number and prescription number.
16. No overage charges will be accepted. Any cost to replace damaged or incorrect products will be the responsibility of the contractor. Replacements shall be received within three (3) hours of notification by the VA.
Ordering:
Orders for Illucix (Gallium 68 PSMA-11) and/or NETSPOT (Ga-68 Dotatate) will be placed on an as needed basis. On-line orders can also be placed when permissible. The Nuclear Pharmacy will package and deliver individual unit dose for each patient on the date and calibration time specified when order was placed. Only Nuclear Medicine Technologists are authorized to place radiopharmaceutical orders.
Normal orders shall be placed during the workday, and delivery shall be made to the Lebanon and Pittsburgh VA Medical Centers, Nuclear Medicine Department on the date and calibrated time specified at the time of order placement. Due to the demands of the Medical Center patient care requirements, contractor shall provide routine delivery and pick-up as many times as required by the Lebanon and Pittsburgh VA Medical Centers. In the event that the requirements may be determined in advance, a longer delivery time may be scheduled accordingly. In accordance with the following:
The delivery order shall include the following information: contract item(s) and quantity, time(s) of delivery, and applicable VA order number.
Orders can be placed by the Lebanon and Pittsburgh VA Medical Centers via telephone, fax, or e-mail.
Ordering Contact Information: Contractor shall provide contact information for the placement of orders for items listed in the Schedule of Supplies and Services
The Lebanon VA Medical Center CORs assigned to this contract will be the only individuals authorized to place orders under this contract:
POC: Jasir Nayati, Jasir.Nayati@va.gov
POC: Amy Landis, Amy.Landis@va.gov
POC: Imani Crumlin, Imani.Crumlin@va.gov
The Pittsburg VA Medical Center POCs assigned to this contract will be the only individuals authorized to place orders under this contract:
POC: Kenneth Disbio, Kenneth.Disibio@va.gov
POC: Tika Dahal, Tika.Dahal@va.gov
POC: Jared McKee, Jared.McKee@va.gov
Emergency Ordering Procedures: An added cost is provided IAW with line items 1 & 2 of the schedule of items for the base for emergency preparation and delivery service of radiopharmaceuticals at other than normal working hours. Normal business hours are considered Monday through Friday: 7:00 am 4:30 pm.
Federal Holidays: New Year s Day; Martin Luther King, Jr Day; President s Day; Memorial Day; Juneteenth; Independence Day; Labor Day; Columbus Day; Veterans Day; Thanksgiving Day; Christmas Day and any other day specifically declared by the President of the United States as a National holiday.
Deliveries: All orders will be delivered on an agreed upon schedule between the contractor and the Department of Veteran Affairs prior to shipment. No delivery charge shall be made for additional deliveries during normal working hours, Lebanon: 7:00 a.m. 4:00 p.m., Pittsburgh: 6:30 a.m. 4:30 p.m. Delivery will be coordinated between the designated POC and the contractor. In the event that an after-hours must occur, those deliveries shall be made by contacting the medical center police to unlock the designated room at each facility for safe package delivery and storage.
Delivery Locations:
Lebanon VA Medical Center, 1700 S. Lincoln Ave. Lebanon, PA 17042. Building 1, room G025, Nuclear Medicine department.
VA Pittsburgh Health System, University Drive, Pittsburgh PA 15215. Room BW-222, Nuclear Medicine department.
All annual quantities are estimates. The contractor will only be paid for items and quantities ordered and delivered.
Schedule of Supplies
CLIN
Product description
Estimated Quantities/yr.
0001
Illucix (Gallium GA 68 PSMA-11)-LEB
108 unit doses
0002
Illucix (Gallium GA 68 PSMA-11)-PIT
150 unit doses
0003
NETSPOT (Ga 68 Dotatate) -PIT
60 unit doses
