Statement of Work FY25.doc

STATEMENT OF WORK (SOW)

A. GENERAL INFORMATION

1. Title of Project: Statement of Work – Sirtex Sir-Spheres (Y-90 resin microspheres)

2. Scope of Work: The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work, except as may otherwise be specified.

3. Background: Yttrium-90 (Y-90) SIR-Spheres resin microspheres from Sirtex is used as a treatment for selected patients with unresectable cancers, especially hepatic cell carcinoma or metastasis to the liver. The treatment involves injecting tiny microspheres of radioactive material into the arteries that supply the tumor.

4. Performance Period:

For time period covering Fiscal Year (FY) 2025 (Oct 1, 2024 through Sept 30, 2025) Normal working hours for the Nuclear Medicine Service at VA Palo Alto Health Care System (VAPAHCS) are Monday through Friday, 7:30 a.m. through 5:30 p.m. Y-90 SIR-Spheres treatments are only provided during normal operating hours excluding weekends and holidays. See Section F for list of observed Federal Holidays.

4. Delivery Address:

Radiopharmaceuticals shall be delivered to:

VA Department of Veterans Affairs VA Palo Alto Health Care System Bldg 100, Room E1-340 Nuclear Medicine Department

3801 Miranda Ave.

Palo Alto, CA 94304

Doses cannot be delivered to warehouse.

B. GENERAL REQUIREMENT

The contractor agrees to provide prepared Y-90 SIR-Spheres treatment dose(s) and associated materials to VAPAHCS as ordered and at the agreed upon price. Orders shall be placed at least 7 days prior (Monday through Friday by 4:30PM) for delivery on the agreed upon date. Dose must be delivered directly to Nuclear Medicine Service during normal working hours, with Nuclear Medicine staff present.

C. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES

1. Contractor must be licensed by the Nuclear Regulatory Commission and be regularly established in the business of providing radiopharmaceuticals. Offeror must provide copies of licenses and certifications along with quote to the Contracting Officer.

2. Contractor shall have available an adequate supply of contract products to meet the requirements of the VAPAHCS at its distribution points.

3. Contractor shall label all supplies as to the amount of radiopharmaceutical, preparation time, expiration time, date, etc. compliant with nuclear medicine information system.

4. All packaging of radioactive material MUST BE clearly labeled RADIOACTIVE on the outside of the shipping carton.

5. Contractor shall perform all quality control procedures as required by Federal and State regulatory agencies and Joint Commission.

6. Contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, FDA, OSHA and all other agency rules and regulations (Federal and State).

7. Contractor shall accept returns for credit under the following conditions:

a. Product(s) ordered or shipped in error.

b. Product(s) damaged in shipment

c. Concealed shipping damages

d. Recalled product(s)

e. Outdated products in unopened, original container (specifically authorized for return by manufacturer).

8. Contractor agrees to provide the delivery option of third-party. Contractor will handle all the logistics of this delivery option.

D. SCHEDULE FOR DELIVERABLES

Orders can be placed by the VAPAHCS via telephone, fax, or e-mail.

The following Federal Holidays are observed:

Labor Day

First Monday in September

Thanksgiving Day

4th Thursday in November

Delivery of supplies by the scheduled date will be complete except as otherwise authorized by the Ordering Personnel.

If for any reason any deliverable cannot be delivered within the scheduled time frame, the contractor is required to notify the VAPAHCS Nuclear Medicine Service by phone or in writing as soon as is feasible.

E. CHANGES TO STATEMENT OF WORK

Any changes to this SOW shall be authorized and approved only through written correspondence from the Contracting Officer (CO). 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 CO shall be borne by the contractor.

HES / HIS Contracting SOP

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