Y90 SOW 2024.pdf

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Therasphere Y90
Solicitation number
FA442724Q0133
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This document is a Statement of Work (SOW) for the procurement of Yttrium-90 TheraSphere for the radiotherapy treatment of hepatocellular carcinoma (HCC) and secondary tumors to the liver. The contractor will be required to provide the TheraSphere doses, which consist of millions of microscopic, radioactive microspheres that are infused into arteries supplying the liver tumors. Dosages can vary from 3 Gbq to 20 Gbq. The contractor must be able to ship the items overnight prior to the scheduled procedure date and follow all state and federal regulatory guidelines. The products must be FDA compliant and approved for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable HCC or hepatic metastases.

The related federal contract opportunity is a Special Notice for a sole source award to BOSTON SCIENTIFIC CORP for the FDA-approved TheraSphere doses product, under the authority of FAR 13.501(a)(1)(ii). The award will be for a base year from September 1, 2024, to August 31, 2025, with four option years. The applicable NAICS code is 325412, Pharmaceutical Preparation Manufacturing, with a small business size standard of 1,250 employees. Responses to this notice are due by August 5, 2024, at 10:00 a.m. (PST).

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Statement of Work (SOW) for Yttrium-90 TheraSphere

Yttrium-90 TheraSphere

60 MDTS Interventional Radiology requires Yttrium-90, TheraSphere for the radiotherapy treatment of hepatocellular carcinoma (HCC) and secondary tumors to the liver. TheraSphere consists of millions of microscopic, radioactive microspheres that are infused into arteries that supply the liver tumors.

Description: Once a patient is identified as requiring the TheraSphere treatment, the contractor will be contacted via email and order form in which we provided required dosage, as well as the day and time of the scheduled procedure. Dosages can vary from 3 Gbq - 20 Gbq. Interventional Radiology will email the required order form and receive confirmation order has been placed. Once the contractor has shipped, shipping confirmation should be sent to the nuclear medicine department.

Point of Contact: The contractor shall coordinate with Interventional Radiology at David Grant Medical Center at 707-423-7244. Shipments are required to be delivered to the Nuclear Medicine Dept, 707-423-7663

Shipping Address:

David Grant Medical Center 101 Bodin Circle, Travis Air Force Base A TIN: TSgt Degrate/Nuclear Medicine Travis AFB, CA 94535 United States

Special Requirements: These items decay and must be received in a timely manner.

Contractor will ensure items are shipped overnight prior to the procedure date.

Shipments must follow all state and federal regulatory guidelines.

Qualifications/Certifications:

All products must be FDA compliant Must be able to provide technologies for oncologic interventional procedures Must be able to provide multiple dose sizes that vary from 3 Gbq - 20 Gbq Must be approved for use in radiation treatment or as a neoadjuvant to surgery or transplantation in patients with unresectable hepatocellular carcinoma (HCC) or hepatic metastases who can have placement of appropriately positioned hepatic arterial catheters

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