Attachment 1 - Statement of Work - Nuclear Radiopharmaceuticals.docx

Statement of Work Nuclear Medicine Radiopharmaceuticals Deliveries

1. Background: The Cheyenne VA Medical Center Diagnostic Imaging (Radiology) Service located at 2360 E Pershing Blvd, Cheyenne, WY 82001 requires recurring deliveries of Nuclear Medicine Radiopharmaceuticals to support Nuclear Medicine diagnostic exams, including Nuclear Cardiac Stress Tests and other imaging procedures. Due to the short half‑lives and storage limitations of radiopharmaceuticals, the medical center cannot maintain bulk inventory and relies on daily, procedure‑driven deliveries coordinated by the Contracting Officer Representative (COR).

2. Scope: The Contractor shall provide all personnel, equipment, facilities, materials, supplies, licenses, transportation, and supervision necessary to manufacture and deliver radiopharmaceuticals on a recurring daily basis as ordered. Deliveries must support all Nuclear Medicine procedures performed at the Cheyenne VA Medical Center and must comply fully with all applicable regulatory safety and security requirements.

3. Applicable Regulations and Standards: The Contractor shall comply with all federal, state, and local regulations applicable to the preparation, handling, transport, and delivery of radiopharmaceuticals, including but not limited to:

· Nuclear Regulatory Commission (NRC) regulations

· Department of Transportation (DOT) hazardous materials regulations

· U.S. Pharmacopeia (USP) standards

· State radiation control statutes

· VA Radiation Safety Policies

· FDA regulations applicable to manufacturing and distribution The Contractor must maintain all required licensure and provide documentation upon request.

4. Requirements:

4.1 Ordering & Delivery

a. Daily orders will be placed by the COR based on physician‑ordered exams.

b. Deliveries must arrive in a timeframe that preserves radiopharmaceutical integrity according to half-life requirements.

c. Deliveries must not be routed to general receiving. The Contractor shall deliver directly to an authorized user or licensed nuclear pharmacist at the Cheyenne VA facility.

d. Delivery personnel must comply with all security and radiation safety requirements when entering VA property.

4.2 Packaging & Transport

a. All radiopharmaceutical packaging must meet NRC and DOT requirements for radioactive materials.

b. Packages shall include appropriate shielding, labeling, exposure rate limits, and documentation.

c. The Contractor must ensure chain‑of‑custody procedures consistent with regulatory guidance.

4.3 Product Quality

a. All radiopharmaceuticals shall meet USP specifications regarding strength, purity, sterility, and radiochemical identity.

b. Dose calibrations must be accurate and documented.

c. Any deviation that may affect patient safety or image quality must be immediately reported to the COR.

4.4 Required Radiopharmaceuticals

The contract will include, at minimum, the following categories of products (specific line items and estimated quantities will be listed in the pricing schedule):

Types of Nuclear Medicine Radiopharmaceuticals

5. Place of Performance Cheyenne VA Medical Center Diagnostic Imaging (Radiology) 2360 E Pershing Blvd Cheyenne, WY 82001

6. Government‑Furnished Property or Services: None. The Government will not provide facilities, equipment, or supplies.

7. Contracting Officer Representative (COR) The COR will:

· Place daily orders

· Verify compliance with delivery and safety requirements

· Monitor contractor performance The COR is not authorized to change price, quantity, scope, or terms of the contract.

8. Contractor Personnel & Security Requirements

· Delivery personnel must comply with VA access and identification requirements.

· All employees handling radioactive materials must have appropriate training and licensing.

· Contractor personnel must comply with all VA policies regarding patient privacy, facility access, and conduct.

9. Invoicing Invoices shall be submitted electronically via the Tungsten/VA FSC system and must include:

· Contract number

· Order/delivery date

· Product descriptions

· Unit dose/activity

· Unit price and extended price

· Delivery confirmation Invoices must match delivered quantities and must not include any unauthorized charges.

10. Special Requirements

· Emergency or same-day deliveries may be required for urgent diagnostic needs.

· The Contractor must maintain procedures for reporting damaged, leaking, or compromised shipments.

· The Contractor must notify the COR immediately of any NRC‑reportable event related to delivery or handling.

End of Statement of Work