The document outlines a solicitation and contract for providing Yttrium-90 (Y-90) SIR-Spheres, a radiopharmaceutical used in treating certain cancers, specifically to the VA Palo Alto Health Care System. The contract is set for the performance period from October 1, 2024, to September 30, 2025, with orders required to be placed at least seven days in advance. The contractor must comply with various regulatory requirements regarding the handling and labeling of radioactive materials and must be licensed by the Nuclear Regulatory Commission. Additionally, the contractor is responsible for all quality control procedures and must provide options for third-party delivery logistics.
The pricing schedule includes specific items like the SIR-Spheres doses and associated delivery components with the contractor required to submit invoices electronically. Importantly, the contract stipulates adherence to numerous federal regulations and terms applicable to commercial contracts. The overarching purpose is to ensure safe and compliant delivery of specialized medical materials to support the VA’s medical services while maintaining regulatory adherence and operational efficiency.
The Statement of Work (SOW) outlines the requirements for a project involving the provision of Yttrium-90 (Y-90) SIR-Spheres resin microspheres for cancer treatment at the VA Palo Alto Health Care System (VAPAHCS). The contractor is responsible for delivering these radiopharmaceuticals during business hours, ensuring all regulatory compliance. Key tasks include obtaining necessary licenses, maintaining adequate supply, proper labeling of products, and adhering to extensive quality control procedures in accordance with federal and state regulations. The contractor must also accept returns under specified conditions and is required to inform VAPAHCS promptly of any delivery issues. The contract spans FY 2025 and includes specific delivery protocols and observance of federal holidays. Changes to the SOW must be approved in writing by the Contracting Officer. This document serves to facilitate the procurement of medical supplies for treating patients with unresectable cancers, emphasizing compliance and operational standards.