6505-- Intent to Sole Source Xofigo - Radiopharmaceutical for Lebanon VAMC

Active

Contract Opportunity

INTENT TO SOLE SOURCE

The Department of Veterans Affairs, Network Contracting Office 4 (NCO4) intends to sole source a contract for Radiopharm Xofigo to Lebanon VA Medical Center. All work is to be completed in accordance with statement of Need. This sole source contract will be solicited and negotiated with Cardinal Health 414, LLC 7000 Cardinal PL, Dublin, OH under the authority of FAR 13.106-1 Single Source Justification.

See attached Draft Statement of Work (SON).

The North American Industry Classification System (NAICS) code for this procurement is 325412, In-Vitro Diagnostic Substance-Product Service Code for this requirement is 6505, Drugs and Biologicals. The Small Business Administration (SBA) size standard is 1300.

Interested vendors that can meet this requirement, shall identify their interest and capability, and respond to this notice by 03/13/2025 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 the Lebanon VA Medical Center.

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 Government Scientific Source, Inc.

STATEMENT OF WORK
Lebanon VA Medical Center

Title of Project: Procurement and Delivery of radioactive material in the form of Xofigo (Radium 223 dichloride) to the Lebanon VAMC
Scope of Work: Cardinal Health referred to as the contractor shall provide Xofigo Radium 223 dichloride to the Lebanon VA Medical Center as outlined in this SOW. The contractor shall perform to the standards in the contract and meet all necessary Federal regulatory requirements and guidelines.
Background: Xofigo Radium 223 dichloride is an alpha particle- emitting therapeutic agent indicated in the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. The VA Medical Center in Lebanon, PA, is establishing a contract to meet the need for delivery, storage, inventory management, packaging and shipment preparation, distribution, and transportation of Xofigo Radium 223 dichloride in support of the VA Medical Center Nuclear Medicine needs. It is the intent of this contract to have a supply of Xofigo readily available for shipment/transportation and continuous Inventory Management Services and equipment during normal working hours as described in this Statement of Work. Offerors shall furnish and deliver F.O.B. Destination all items as listed in the Schedule of Supplies and Services and others that may be needed in the future. When applicable, preference will be given to contractors who supply products from non-High Enriched Uranium sources (non-HEU). Contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing Xofigo Radium 223 dichloride.
Performance Period: The Government is requesting a one (1) year contract with a period of performance, June 29, 2025 to June 28, 2026.
Type of Contract: Firm-Fixed Price
Point of Contact: Delivery shall be coordinated with the designated technical POC:

Nominated COR: Jasir Nayati
Phone: (717) 272-6621 x3621
Email: Jasir.Nayati@va.gov

Note: The POC has no authority to change the terms and conditions of the awarded contract.
GENERAL REQUIREMENTS
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.

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 place when permissible. Cardinal Health Nuclear Pharmacy will package and deliver individual unit dose for each patient on the date and calibration time specified when order was placed.
No delivery charge shall be required for additional deliveries during normal working hours.
Contractor shall provide an adequate supply of contract products to meet the requirements of Lebanon VA Medical Center.
Contractor shall provide a barcode labeled insert to allow scanning data into existing nuclear medicine information management system (NMIS). Contractor product barcode system shall be compatible with Nuclear Medicine Information Systems (NMIS) in general.
Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies.
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. Contractor shall provide copy of their radioactive material license with their proposal.
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.
Contractor shall meet all Nuclear Regulatory Commission (NRC), Department of Transportation, FDA, OSHA and all other agency rules and regulations (Federal and State). Contractor must maintain all 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 quality control 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 perform quality control on each agent dispensed.

14. 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).

15. 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.

16. 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.

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

18. All defective or inferior products shall be replaced within the timeline specified at no
costs to the VA.

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 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 Lebanon VA Medical Center. 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 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: April Kurtz, April.Kurtz@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: 6:30 am 4:30 pm.

The Lebanon VA Medical Center considers the following Emergency duty hours:

Weekdays (Monday Friday) 4:30 pm 6:30 am
Weekends (Saturday/Sunday) All hours
Federal Holidays: A list of the expected Federal Holidays is as follows: New Year s
Day, Birthday of Martin Luther King, Jr., Washington s Birthday, 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 to be a national holiday.

Deliveries: All orders will be agreed upon between the contractor and the Department Of
Veterans Affairs prior to shipment. No delivery charge shall be made for additional deliveries
during normal working hours, 7:00a.m.-4:00 Monday Friday.

Emergency Deliveries: Requests for emergency doses shall be delivered within time frame
Agreed upon between the contractor and Department of Veteran Affairs. Emergency and
priority orders consist of less than 20% of the monthly schedule. Radioactive shipments
prepared in advance to anticipate emergency or routine studies are not acceptable.

After Hours delivery: Weekend (Saturday/Sunday) and all Federal Holiday (or any other day
specifically declared by the President of the United States to be a national holiday) deliveries
shall be made by contacting the Veterans Medical Center Police to unlock Room G025 for
placement of the packages in the designated pass-through.

Contractor Early Deliveries: When the Contractor offers an earlier delivery date and time
than specified, the Government reserves the right to award whether in accordance with the
requested schedule or in accordance with the earlier schedule offered by the contractor. If a
contractor offers a longer delivery than that requested, the Government may award based on
that schedule. If the contract offers no other delivery schedule, the delivery requested shall
apply.

Delivery proposed

Delivery of supplies by the scheduled date will be complete except as otherwise authorized by the Ordering Personnel.
The Government may terminate this contract in whole or in part if the contractor fails to meet the required delivery schedule. The Contractor shall be liable for a fixed, occurring amount until the Government may reasonably obtain delivery of similar supplies. The contractor shall not be charged with damages when the delay in delivery arises out of causes beyond the control and without the fault or negligence of the contractor.
Delivery date and time specified may be adjusted by the Contracting Officer. The Contractor will be notified of this change at least seven (7) days prior to the original or adjusted delivery date.
Delivery Location: Radiopharmaceuticals shall be delivered to:

(Room G025) located within the Nuclear Medicine Department
Lebanon VA Medical Center
1700 S. Lincoln Ave
Lebanon, PA 17042

Access to this room during non-business hours shall be obtained by contacting VA Police Service.

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. 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.

Damages In-transit: Under FOB Destination procedures, any in-transit damage is the
responsibility of the provider. The contractor is responsible for notifying the Contracting Officer
or Contracting Officer Representative within 24 hours after loss or damage of material is
known by the contractor. The contractor shall be responsible for initiating action to replace all
damaged or missing material to the Government.

Packaging and Shipment Preparation: All unit dose radiopharmaceuticals delivered must
have a bar code with it so the dose can be scanned into the department s dose tracking
system that it owns. All radiopharmaceuticals shall be delivered in ready-to-use unit dose
form in lead-shielded containers. Plastic shrink wrap fitted at union of container cap and base
should be present to ensure an untampered seal.

Calibration/labels: All radiopharmaceuticals shall be calibrated and labeled with concentration, calibration, time, total volume, total activity, lot number and prescription number.

Supplier Source Information: Product information including supplier's source of
radiopharmaceuticals, package inserts, results of quality control testing performed by supplier
and copies of supplier's license and procedures shall be provided at no additional charge.

Added charges: Contractor shall not add to the invoice the cost of overages. Any cost to
replace damaged or incorrect products will be at the cost of the contractor. Replacements shall
be received within three (3) hours of notification by the VA.
CLIN
Description
Estimated Quantity (uCi)
001
Radium Ra 223 dichloride (Xofigo)
1500

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