Y-90 Sirtex Sirspheres Statement of Work FY25.doc

HEALTH ENTERPRISE STRATEGY/HEALTH INFORMATICS STRATEGY

Statement of Work

ATTACHMENT 1 - STATEMENT OF WORK

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 FY 2025 (Oct 1, 2024 through Sept 30, 2025) Normal working hours for the Nuclear Medicine Service at 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.

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.

Required Therapeutic Radiopharmaceutical: Y-90 SIR-spheres resin microspheres Please reference “Attachment 2 – Price-Cost Schedule for Estimated Usage”.

Proposals will be considered only from Offerors who are regularly established in the business that is called for, and who in the judgment of the Contracting Officer are financially responsible and able to show evidence of the reliability, ability, experience, equipment, facilities and personnel directly employed or supervised by them to render prompt and satisfactory service.

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 radio pharmacy Y90 Sirspheres dose draw, preparation service, and delivery as needed by the VA. 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:

New Year’s Day

Birthday of Martin Luther King, Jr.(day of observance)

Washington’s Birthday

Memorial Day

Independence Day

Labor Day

Columbus Day

Veterans Day

Thanksgiving Day

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

Radiopharmaceuticals shall be delivered to:

Bldg 100, Rm E1-340 located within the Nuclear Medicine Department

VAPAHCS

3801 Miranda Ave.

Palo Alto, CA 94304 Dose cannot be delivered to warehouse.

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 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.

F. GOVERNMENT RESPONSIBILITIES

The Nuclear Medicine Service of the VAPAHCS shall ensure that:

· The specification of the Product (radiopharmaceutical) is safe for the intended use

· The products are handled in a safe manner, and

· Any waste originating from the Products is disposed of in accordance with any relevant regulations.

G. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

HES / HIS Contracting SOP

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HES / HIS Contracting SOP