SOW RFI.pdf

STATEMENT OF WORK

1. PURPOSE

The overall purpose is to acquire the Y-90 microspheres (SIR Spheres) intended for intra-arterial radiation therapy (radioembolization) to liver tumors. These doses are used in procedures for the Interventional Radiology Department at Michael E. DeBakey VA Medical Center. This transaction will be to set up a Base plus 4 option year agreement with the vendor Sirtex Medical.

2. SCOPE

Contractor shall provide the doses and support services in the Interventional Radiology (IR) section of the Michael E DeBakey VA Medical Center, 2002 Holcombe Blvd, Houston, Texas 77030. All services shall be done in a first-class manner and must meet manufacturers and VA specifications.

3. BACKGROUND

Y-90 (Yttrium-90) is a targeted liver cancer therapy used in the treatment of hepatocellular carcinoma (HCC) and other liver tumors. It is a form of radioembolization where Y-90, a radioactive isotope, is delivered directly to the liver tumors through tiny beads. Currently there are two Y-90 products available, Theraspheres, which we currently use at MEDVAMC, and SIR-Spheres. Because we currently utilize only one Y-90 vendor, should that product be subject to recalls/backorders or other forms of unavailability, several significant effects can arise:

• Limited Treatment Options: Patients with liver cancer who are candidates for Y-90 may have limited alternatives for targeted therapy. This can reduce their options to other treatments, which may not be as effective or suitable.

• Disease Progression: Delay or inability to provide Y-90 treatment may allow cancer to progress, potentially decreasing the chances of successful treatment outcomes and overall survival rates.

• Increased Burden on Other Treatments: Hospitals may need to rely more heavily on other forms of treatment like systemic chemotherapy, surgery, or other forms of radiation therapy. This could lead to higher demand and potential shortages in other therapeutic areas.

• Patient Well-Being: The effectiveness and targeted nature of Y-90 treatments help minimize damage to surrounding healthy tissue, which is beneficial for patient well-being. Without access to Y-90, patients may experience more side effects and a decline in their quality of life.

• Health Care Costs: Alternative treatments that are less geographically targeted may lead to increased healthcare costs due to extended hospital stays, additional medications, and more intensive care requirements.

• Clinical Trials and Research: The inability to provide Y-90 might impact ongoing clinical trials and research studies focused on evaluating the therapy's effectiveness and exploring new indications for use. This can stall advancements in treatment protocols.

4.1 SALIENT CHARACTERISTICS

• SIR-Spheres Y-90 resin microspheres

• Siros delivery dome

• Siros D-vial prep set

• Siros delivery set

• Syringe Shield

• Nalgene Acrylic Waste Container w/PE Bottle

DRAFT

4.2 PRODUCT SPECIFICATIONS AND FEATURES

Shall be provided to preserve continued functions that these treatments provide to the IR department.

5. DELIVERY, WORK HOURS, AND COORDINATION WITH MEDVAMC FOR SETUP

AND TRAINING SERVICES

Delivery Timeframe:

All Deliverables shall be completed based on a schedule of work provided after award, preferably within six months of Contractor’s receipt of a delivery task order from the Contracting Officer.

Work Hours:

All work shall take place during clinical hours (Monday through Friday, 8:00 am to 4:30 pm excluding weekends and federal holidays). Federal holidays include the following: New Year’s Day, Washington’s Birthday, Martin Luther King’s Birthday, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving, Christmas, and any days declared by the Government as holidays.

Coordination with MEDVAMC for Services:

Contractor shall be required to coordinate with the MEDVAMC Contracting Officer’s Representative (COR) (to be determined after the award of the delivery task order) for scheduling the setup maintenance and services.

6. TESTING AND CERTIFICATION

The Contractor shall notify the COR in writing that the system is ready for acceptance testing, and that it meets all requirements as specified. Submission of this notification of system readiness shall be accomplished by the contractor prior to the beginning of the scheduled Government Acceptance Test.

7. GOVERNMENT ACCEPTANCE TEST

Contractor shall perform the Government Acceptance Test in the presence of the COR for proof-of-performance. The Government Acceptance Test shall be performed at a mutually agreed date and time.

Upon completing the Government Acceptance Test successfully, Contractor shall document the success of this Government Acceptance Test and furnish a copy to the COR before Contractor’s Representative departs the VA premises. Payments can be withheld until final acceptance by the Government.

8. WARRANTY REPAIR SERVICE

Fully covered warranty for 12 months from the date of acceptance

9. EQUIPMENT MANUALS

The Contractor shall furnish User Manual and reference guides for the specified equipment.

10. PRODUCT MODIFICATION, REMOVAL OR RECALL:

If any product awarded under this solicitation requires modification, is removed or recalled by the Contractor or manufacturer, or if any required modification, removal or recall is suggested or mandated by a regulatory or official agency, the following steps will immediately be taken by the Contractor or manufacturer:

a. Notify the Contracting Officer, in writing, by the most expeditious manner possible. Provide two copies of the notification which shall include, but not be limited to the following:

(1) Complete item description and/or identification, order numbers from customers, and the contract number assigned because of an award on this solicitation.

(2) Reasons for modifications, removal or recall.

(3) Necessary instructions for return for credit, replacement or corrective action.

b. Provide the above information to all agencies and VA Facilities who purchased the product.

The Contracting Officer shall be provided with a copy of the notification in b. above, and a list of all agencies and/or VA facilities notified

c. Contractor shall be responsible for any costs associated with the above.

11. INVOICE AND PAYMENT

Contractor shall invoice the MEDVAMC in arrears only after the completion of all Deliverables identified in this Statement of Work. Invoice shall be properly prepared and sent to VA Financial Service Center at:

P.O. Box 149971 Austin, Texas 78714-8971

The invoice shall be properly prepared in accordance with FAR 52.212-4, contain sufficient details, and at a minimum, include the following details:

a Deliver task order number b Description of the supply/service rendered.

c Billing period/date when the supply/services were rendered.

d Invoice number and date

Payments will be made in accordance with the Prompt Payment Act out of the Government annual appropriated funds obligated in a task order which will be issued after the contract is awarded.

Notes: invoices that are not in compliance with the requirements under this paragraph will be rejected for payments and required to be resubmitted.

End of Statement of Work