NaF NH3 Posluma SOW-.docx

STATEMENT OF WORK

CENTRAL ARKANSAS VETERANS HEALTHCARE SYSTEM

Little Rock, AR

NaF NH3 Posluma for PET CT

A. GENERAL INFORMATION

1. Title of Project: NaF, Ammonia N13, & Posluma for PET CT Imaging

2. Background: Nuclear Medicine requires that all radiopharmaceuticals be delivered within allowable timeframes. There is a very short for most radiopharmaceuticals needed to perform required tests. In addition, this is a highly regulated service and must meet requirements from the Nuclear Regulatory Commission. CAVHS Imaging Service will be deploying a new imaging modality, PET CT, in late FY25 and needs to acquire the associated radiopharmaceuticals.

3. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work (SOW), except as may otherwise be specified. This shall include delivery of routine orders for next day NaF, Ammonia N13, & Posluma and delivery within one (1) hour for all urgent or emergent requests for NaF, Ammonia N13, & Posluma using the proper transporting protocols and meeting the standard classifications to identify radiation limits established by the Department of Transportation and the Nuclear Regulatory Commission.

4. Performance Period: Base (12 months) plus four (4) 12 months option periods. Base year expected to begin on 9/15/2025.

5. The contractor shall complete the work required under this SOW 24 hours a day, 7 days a week. This includes off hours, weekends, and Federal holidays as required for emergent or urgent cases from date of award, unless otherwise directed by the Contracting Officer. The Federal holidays are New Year’s Day, Martin Luther King Day, Presidents Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving Day, and Christmas Day.

6. Type of Contract: Firm-Fixed-Price Indefinite Delivery Indefinite Quantity

7. 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: Reference # 03-01082-01 Amendment # 76.

B. REQUIREMENTS

1. The contractor shall provide delivery by 0630 a.m. on all routine orders for NaF, Ammonia N13, & Posluma and shall provide delivery within 1 hour for all urgent or emergent requests for NaF, Ammonia N13, & Posluma.

2. The contractor shall ensure that all deliveries to Central Arkansas Veterans Healthcare System (CAVHS) are made following the proper transporting protocol and that the standard classification to identify radiation limits established by the Department of Transportation and the Nuclear Regulatory Commission are met.

3. The contractor shall be (or use) a compounding pharmacy that is licensed by the State Board of Pharmacy in which it is located, and which is in good standing (no actions pending or unresolved such as a probationary period).

4. The contractor shall ensure that all transporting personnel have proper identification and documents when delivering supplies to CAVHS.

5. The contractor shall establish a method to hand-off to the appropriate Nuclear Medicine personnel during delivery.

6. The contractor shall ensure that all containers delivered to CAVHS are sealed appropriately to ensure that the package has not been compromised during transportation.

7. The contractor shall pick up WBC scans within 1 hour of notification and shall return the tagged blood to CAVHS within 3 hours of time of pick-up.

8. The contractor shall ensure that samples are correctly labeled with patient identifiers when picked up and validated upon delivery of the tagged product.

9. The contractor shall ensure that all counts of drugs be correct on delivery, with no more than five errors per year and If for any reason, any deliverable cannot be delivered within the scheduled timeframe, the contractor shall explain why in writing to the Contracting Officer Representative (COR) and shall include a firm commitment of when the work will be completed. This notice to the COR shall cite the reasons for the delay. The Contracting Officer will then review the facts and issue a response in accordance with applicable regulations.

10. The contractor shall deliver all products at no additional charge during normal business hours.

11. The Contractor shall obtain, maintain, and provide evidence of at the request of the Government, U.S. Food & Drug Administration (FDA) approval of the radiopharmaceuticals prior to shipment.

C. SCHEDULE FOR DELIVERABLES

If for any reason, any deliverable cannot be delivered within the scheduled timeframe, the contractor shall explain why in writing to the Contracting Officer and shall include a firm commitment of when the work will be completed. This notice to the Contracting Officer shall cite the reasons for the delay. The Contracting Officer will then review the facts and issue a response in accordance with applicable regulations.

D. DELIVERY LOCATION

Central Arkansas Veterans Healthcare System 4300 West 7th Street, Room 1D-178 Little Rock, AR 72205

E. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the Contracting Officer. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the Contracting Officer shall be borne by the contractor.

F. GOVERNMENT RESPONSIBILITIES

Government shall ensure that Nuclear Medicine staff are available to accept delivery of radiopharmaceutical supplies at the CAVHS.

G. CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables and all associated Working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order are the exclusive property of the U.S. Government and shall be submitted to the Contracting Officer at the conclusion of the task order.

2. No information shall be released by the contractor. Any request for information relating to this task Older presented to the contractor shall be submitted to the Contracting Officer for response.

3. Press releases, marketing material or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the Contracting Officer.

H. POST-AWARD CONFERENCE

The contractor shall participate in a post-award conference unless waived by the Contracting Officer. This meeting shall provide an introduction between the Contractor personnel and Government personnel who will be involved with the contract. The meeting shall provide the opportunity to discuss technical, management and security issues. The Post Award Conference will aid both the Government and Contractor in achieving a clear and mutual understanding of all requirements and identify and resolve any potential issues. Contractor shall be prepared to discuss any items requiring clarification and gather information as necessary to support each deliverable. The VA will provide the Contractor with a written summary of the Post-Award Conference.