6505--Intent to Sole Source | 5 Year Consolidated Contract Indefinite Delivery/Indefinite Quanity | Radiopharm Xofigo, Illucix, Netspot | Lebanon, Pittsburgh, Philadelphia VA Medical Centers

INTENT TO SOLE SOURCE

The Department of Veterans Affairs, Network Contracting Office 4 (NCO4) intends to sole source a consolidated contract for Ga-68 Netspot, Ga-68 Illucix, and Ra-223 Xofigo Radiopharmaceuticals for the Lebanon, Philadelphia, and VA Pittsburgh Healthcare System. 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 FAR 6.103-11 Single Source Justification.

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 02/10/2026 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, Pittsburgh, and Philadelphia 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: Xofigo (Radium 223 dichloride), Illucix (Gallium 68 PSMA-11) and NETSPOT (Gallium 68 Dotatate) for Philadelphia, Pittsburgh and Lebanon VA Medical Centers Nuclear Medicine Programs.

Scope of Work: The contractor shall provide timely delivery of name brand only radiopharmaceuticals in the form of Xofigo (Radium 223 dichloride), Illucix (Gallium 68 PSMA-11) and NETSPOT (Gallium 68 Dotatate) to Philadelphia, Pittsburgh, and Lebanon VA Medical Centers as defined in this statement of work. The distributor must be located within the Pittsburgh, Philadelphia and Lebanon Areas due the 68-minute half-life of the Radiopharmaceuticals.

Background: The Philadelphia, Pittsburgh, and Lebanon VA Medical Centers have a need to establish a contract for delivery and inventory management of name brand only radiopharmaceuticals, Xofigo (Radium 223 dichloride), Illucix (Gallium 68 PSMA-11) and NETSPOT (Gallium 68 Dotatate) for their Nuclear Medicine programs. It is the intent of this contract to have a ready supply of Xofigo (Radium 223 dichloride), Illucix (Gallium 68 PSMA-11) and NETSPOT (Gallium 68 Dotatate) available for shipment to include continuous inventory management services during normal working hours as described in this Statement of Work. Contractor shall furnish and deliver all items as listed in the Schedule of Supplies and Services . Contractors who supply products from non-High Enriched Uranium sources (non-HEU) are preferred. The Contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing Xofigo (Radium 223 dichloride); Illucix (Gallium 68 PSMA-11) and NETSPOT (Gallium 68 Dotatate). Philadelphia and Pittsburgh VA Medical Centers have a need for Illucix (Gallium 68 PSMA-11). Xofigo is an advanced radioactive agent used to treat patients with castration-resistant prostate cancer, symptomatic bone metastases, and no known visceral metastatic disease. 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. NETSPOT is also an advanced radioactive PET tracer; however, it is designed to help detect the presence of neuroendocrine tumor cells, aiding in diagnosis and treatment efficacy.

Type of Contract: Firm-fixed priced, Indefinite Delivery, Indefinite Quantity (IDIQ) contract.

Period of performance: The government is seeking a five-year contract, with a period of performance beginning April 1, 2026, through March 31, 2031. Yearly task orders will be executed by each facility and as funding is available.

General Requirements:

1. The dose regimen of Xofigo (Radium 223 dichloride) is 1.49uCi/kg body weight intravenous injection with a total of 6 injections given at 4week intervals.

2. Orders for each Xofigo (Radium 223 dichloride) injection will be placed by completing Xofigo Access Services Patient Support Request Forms including a signed Patient Authorization which is page 2 of the form. 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.

3. No delivery charge shall be required for additional deliveries during normal working hours.

4. Contractor shall be able to provide an adequate supply of product to meet the requirements of Philadelphia, Pittsburg and Lebanon VA Medical Centers.

5. 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.

6. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies prior to shipment.

7. 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.

8. 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.

9. 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.

10. 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).

11. 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.

12. Contractor shall pick up scheduled items, used and unused, for proper disposal at no cost to the Government.

13.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).

14. 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.

15. 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.

16. Any proposed substitutions of product shall have the written approval of the VA Nuclear Medicine Service and the Contracting Officer or his/her designee.

17. Any defective or inferior products shall be replaced within the timeline specified at no cost to the VA. This includes damage during transit, and it 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.

18. All unit dose radiopharmaceuticals delivered must have a bar code for scanning into the department s dose tracking system. 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.

19. All radiopharmaceuticals shall be calibrated and labeled with the patient s name, concentration, calibration, time, total volume, total activity, lot number and prescription number.

20. 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.

21. 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.

Special Requirements:

These radiopharmaceuticals must be readily available for shipment, transportation, and continuous management to meet Nuclear Medicine needs. The distributor must be within the Philadelphia, Pittsburgh and Lebanon- district area in order to account for the 68-minute half-life of these radiopharmaceuticals. Only Nuclear Medicine Technologists are authorized to place radiopharmaceutical orders.

Ordering: Contractor will provide with their proposal contractor s regular work hours, telephone number for call-in orders during regular business hours, contractor s telephone number and instructions for placing emergency orders after contractor s regular work hours to include weekends, contractor s telephone number for expert advice concerning awarded products.

Normal orders shall be placed during the workday, and delivery shall be made to the Philadelphia, Pittsburg and/or Lebanon VA Medical Center, 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 Philadelphia, Pittsburg and/or Lebanon 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 Philadelphia, Pittsburgh and/or Lebanon VA Medical Center 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 Philadelphia VA Medical Center POCs assigned to this contract will be the only individuals authorized to place orders under this contract:

POC: Tarideana Breazeale, Trideana.Breazeale@va.gov

POC: Michael Taite, Michael.Tait@va.gov

Christopher Senay, Christopher.Senay@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. Philadelphia: 7:30 am 4 pm, Monday Friday. 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 Location: Lebanon VA Medical Center, 1700 S. Lincoln Ave. Lebanon, PA 17042. Building 1, room G025, Nuclear Medicine department.

Delivery Location: Philadelphia VA Medical Center: Corporal Micheal J. Crescenz VA Medical Center, 3900 Woodland, Avenue, Philadelphia, PA 19104, Room 3A101B, Nuclear Medicine Department.

Delivery Location: VA Pittsburgh Health System, University Drive, Pittsburgh PA 15215. Room BW-222, Nuclear Medicine department.

Delivery Commitment: Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the Contractor. Failure to perform in accordance with the delivery commitment may be grounds for termination of contract in accordance with the provisions for default. All charges incurred for delivery shall be included in the fee schedule to include fuel surcharges. The Contractor shall provide on an as-needed basis miscellaneous supplies and/or services including but not limited to the following:

OSHA compliant monitoring devices.

Sealed sources for QA procedures.

calibrator calibration.

Annual calibration of survey meters.

RSO safety audits for Federal compliance.

Key Assumptions:

All annual quantities are estimates. The contractor will only be paid for items and quantities actually ordered and delivered.

Schedule of Supplies

CLIN

Product description

Estimated Quantities/yr.

0001

Xofigo (Radium RA 223 dichloride)- LEB

1500 uCi

0002

Xofigo (Radium RA 223 dichloride)- PHIL

1000 uCi

0003

Xofigo (Radium RA 223 dichloride)- PIT

1,900 uCi

0004

Illucix (Gallium GA 68 PSMA-11)-PHIL

450-unit doses

0005

Illucix (Gallium GA 68 PSMA-11)-PIT

150-unit doses

0006

NETSPOT (Gallium Dotatate/Ga68)-PHIL

60-unit doses

0007

NETSPOT (Gallium Dotatate/Ga68)-PIT

60-unit doses