Xofigo SOW 2026 DRAFT.pdf

STATEMENT OF WORK – XOFIGO IDIQ

Part I: General Information

A. Introduction

The Michael E. DeBakey VA Medical Center (MEDVAMC) located at 2002 Holcombe Blvd, Houston, Tx 77030 has a requirement for Nuclear Medicine isotope, specifically Xofigo (Radium Ra-223), for use in the Nuclear Medicine Department for the treatment of patients with castration-resistant prostate cancer symptomatic bone metastases.

B. Background

Xofigo (Radium Ra-223), for use in the Nuclear Medicine Department for the treatment of patients with castration-resistant prostate cancer symptomatic bone metastases. This treatment will provide Veteran’s up to a 30% reduction in the risk of death.

C. Scope

Contractor shall provide all single unit dose of Xofigo (Radium Ra-223), for use in Nuclear Medicine at Michael E. DeBakey VA Medical Center in Houston, Texas.

D. Applicable Documents

10 Code of Federal Regulations Part 35: United States Nuclear Regulatory Commission- Medical Use of Byproduct Material 49 Code of Federal Regulations Part 173 Subpart I: Class 7 (Radioactive) Materials Department of Veteran Affairs Materials Permit: Permit # 42-00084-06 Amendment # 77, Reference Number 030-03255.

Part II: Requirements E. Ordering Requirements

1. The Contractor shall provide personnel for orders to be placed by MEDVAMC employees for Xofigo (Radium Ra-223), during standard hours of care Monday through Friday from 0800 (8:00 AM CST) until 1630 hours (4:30 PM CST), not including Federal holidays.

2. The Contractor shall receive orders for Xofigo (Radium Ra-223), from Staff Nuc Med Technologists assigned to the Nuclear Medicine Department at MEDVAMC. The Contractor shall ensure the Staff Nuc Med Technologist name and contact information that placed the order is included with the Contractor’s internal order processing system so that the Contractor can immediately verify who placed the order at the VA’s request.

3. The Contractor shall calibrate all Radiopharmaceutical doses to ensure proper activity ranges of +/- 20 percent of the specified ordered dose per specific requirements provided by the Nuclear Medicine department based on guidelines outlined in 10 CFR Part 35.

DRAFT

4. Orders may be placed orally, in writing, or by electronic means. Specific personnel authorized to place orders under this contract will be designated in writing upon award of the contract.

5. The Contractor shall notify MEDVAMC Nuclear Medicine department should the inability arise to provide Radiopharmaceutical Xofigo (Radium Ra-223), doses by the required date and time. Notification shall be made within two (2) hours of the Contractor becoming aware of the inability to provide the required doses.

F. Delivery Requirements

1. The Contractor shall deliver ordered Radiopharmaceutical doses to:

Department of Veterans Affairs Michael E. DeBakey VA Medical Center 2002 Holcombe Blvd.

Nuclear Medicine Department, Room 2C-254D Houston, Texas 77030

• Access to MEDVAMC during non-business hours shall be obtained by locating the VA Police located in the Emergency Department. The VA Police will accompany the delivery Person to the Nuclear Medicine department and supervise the delivery.

2. The Contractor shall ensure all orders are delivered at least 60 minutes of the calibration time specified on the order.

3. The Contractor shall provide a packing slip accompanying all Radiopharmaceutical shipments to the Nuclear Medicine department for all orders placed that is compatible to be scanned into the BioDose.

4. The Contractor shall ensure that all Radiopharmaceutical doses provided are compounded and calibrated by or under the supervision of a certified Nuclear Pharmacist Contractor.

5. The Contractor shall provide courier service licensed to transport radioactive material in accordance with Department of Transportation, Nuclear Regulatory Commission and other applicable regulating authorities enabling the delivery of Xofigo (Radium Ra-223).

G. Additional Requirements

1. The Contractor shall provide any training or education required to meet commercial standards related to use of the radiopharmaceutical Xofigo (Radium Ra-223), to qualified Staff Nuc Med Technologist stationed at the MEDVAMC no later than 60 days after commercial standards changes.

2. The Contractor agrees to credit the MEDVAMC within 30 business days for any Xofigo (Radium Ra-223), doses not administered for medical reasons up to 10 doses per fiscal year.

H. Government Responsibilities

1. The Government shall ensure all orders for Xofigo (Radium Ra-223), doses be placed by the MEDVAMC to the Contractor in accordance with currently accepted Contractor guidelines.

Part III: Supporting Information

I. Place of Performance:

All supplies shall be delivered to the:

Department of Veterans Affairs Michael E. DeBakey VA Medical Center 2002 Holcombe Blvd.

Nuclear Medicine Department, Room 2C-254D Houston, Texas 77030

J. Period of Performance: Base + 4

October 1, 2025 – September 30, 2026 October 1, 2026 – September 30, 2027 October 1, 2027 – September 30, 2028 October 1, 2028 – September 30, 2029 October 1, 2029 – September 30, 2030

K. Hours of Work:

Normal business hours for the Nuclear Medicine Department at the MEDVAMC are 8:00 a.m. to 4:30 p.m., Monday through Friday excluding the following federal holidays: New Year's Day, Martin Luther King Day, President's Day, Memorial Day, Juneteenth Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, Christmas, and any other day specifically declared by the President of the United States to be a national holiday.

L. Changes to Statement of Work:

The Contracting Officer is the only person authorized to approve changes or modify any of the requirements under this contract and such changes will be executed bi-laterally in accordance with FAR 52.212-4(c). The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes, which will affect price, quantity, or quality of performance of this contract. In the event the contractor effects any such change at the direction of any person other than the Contracting Officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof.

SCHEDULE OF SUPPLIES/SERVICES

PROVIDE RADIOACTIVE ISOTOPES TO THE DEPARTMENT OF VETERANS AFFAIRS

MEDICAL CENTER, 2002 HOLCOMBE BLVD, HOUSTON, TEXAS 77030, IN UNIT

DOSE, DAILY IN ACCORDANCE WITH PATIENT REQUIREMENTS FROM:

BASE YEAR October 1, 2025_ through September 30, 2026_

BID ITEMS FOR BASE YEAR INCLUDE

BASE

YEAR:

FISCAL YEAR 26 - October 1, 2025 THROUGH September 30, 2026

Description

Est.

Yrly.

Qty. Unit Min Max Unit Cost Total Est. Cost

1 Xofigo (Radium Ra-223) 30 EA 6 30 $375,679.18

TOTAL

COST

$375,679.18

Cost is based on clinical estimated need:(four point nine (4.9) patients/year with each patient receiving up to six (6) doses each 29 doses.

Cost per dose is weight based and current cost set from sole source vendor for this isotope.

Cost is based on FSS Pricing

STATEMENT OF WORK – XOFIGO IDIQ