FY2024 Netspot Statement of Work.doc

HEALTH ENTERPRISE STRATEGY/HEALTH INFORMATICS STRATEGY

Statement of Work

STATEMENT OF WORK

A. GENERAL INFORMATION

1. Title of Project: Statement of Work – Ga-68 Dotatate Diagnostic Radiopharmaceuticals

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: Ga-68 Dotatate (Netspot), is a radioactive diagnostic agent indicated for use with positron emission tomography imaging (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients

4. Performance Period:

Base Year: 10/1/2023 - 09/30/2024 Option Year 1: 10/01/2024 – 09/30/2025

B. GENERAL REQUIREMENT

The contractor agrees to provide prepared Ga68-dotatate (Netspot) dose(s) and associated materials to VAPAHCS as ordered and at the agreed upon price. Orders shall be placed according to the vendor’s ordering protocol for delivery on the agreed upon date. Ordered doses should arrive 30 minutes prior to calibration time.

Required Radiopharmaceuticals:

· Ga-68 Dotatate (Netspot)

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).

D. SCHEDULE FOR DELIVERABLES

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

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

Radiopharmaceuticals MUST be delivered directly to (CANNOT DELIVER TO WAREHOUSE):

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

VAPAHCS

3801 Miranda Ave.

Palo Alto, CA 94304 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.

HES / HIS Contracting SOP

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HES / HIS Contracting SOP