Attachment A - SOW_Specifications.docx

Statement of Work/Specifications

I. Y-90 Resin Microspheres Requirement

1. Scope of Work: Contractor shall provide the radiopharmaceutical, SIR-Spheres Y-90 resin microspheres injection in unit dose form, for treatment of Hepatocellular Carcinoma, for the Phoenix VA Health Care System (PVAHCS) in Phoenix, Arizona Nuclear Medicine Department for a 1 Year Period of Performance, plus four option years.

1.1 Salient Characteristics: The radiopharmaceutical Y-90 resin microspheres, is a radioactive diagnostic agent that must be indicated for use in the Interventional Radiology setting to treat Hepatocellular Carcinoma. Y-90 resin microspheres bind to somatostatin receptors which are the hallmark of neuroendocrine tumors (NETs). Must deliver a concentrated dose of radiation to the tumor(s) to destroy them.

2. Specific Tasks:

2.1. The contractor agrees to provide prepared single unit doses of radiopharmaceuticals and associated materials to PVAHCS as ordered and at the agreed upon price. Orders shall be placed each day (Monday through Friday by 4:30PM) for delivery the next business day or specified future date (Monday through Friday) at least thirty (30) minutes prior to calibration time. A second order may be placed each business day for same day delivery.

2.2. Contractor shall have an adequate supply of contract products available to meet the requirements of the PVAHCS.

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

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

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

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

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e. Outdated products in unopened, original container (specifically authorized for return by manufacturer).

3. Qualifications of Offerors:

3.1. Contractor must be 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.

3.2. 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.

4. Holidays: The following Federal Holidays are observed:

New Year’s Day Birthday of Martin Luther King, Jr. (day of observance) Washington’s Birthday Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veterans Day Thanksgiving Day Christmas Day

5. Ordering: After award, the successful Offeror will be furnished the name(s) of individuals authorized to purchase against the Contract.

5.1. Normally, orders shall be placed during the workday, and delivery shall be required at least thirty (30) minutes prior to calibration the following workday to the PVAHCS, nuclear medicine department. Due to the demands of the Medical Center patient care requirements, contractor shall provide routine delivery and pick-up as many times as required by the PVAHCS at no additional charge. In the event that the requirements may be determined in advance, a longer delivery time may be scheduled accordingly.

5.2. The delivery order shall include the following information: contract item (s) and quantity, time (s) of delivery, and applicable VA order number.

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

5.4. EMERGENCY ORDERING PROCEDURES: Normal business hours are considered Monday through Friday: 6:30 am – 4:30 pm.

5.5. PERSON’S AUTHORIZED TO PLACE ORDERS:

5.6. PVAHCS staff members will be the only individuals authorized to place orders under this contract. Points of contact will be provided to the awardee immediately after contract award.

5.7. Ordering Contact Information: Contractor shall provide contact information for the placement of orders for items listed in the “Schedule of Supplies and Services” Section.

(Please complete the following requested information as part of your submission) POC Name: ____________________________________ Address: ________________________________ City/State/Zip Code: _____________________________ Ordering Phone Number: ________________________________ Ordering Fax Number: _________________________________________ Ordering E-Mail Address: ______________________________________

5.8. When the Contractor offers an earlier delivery date and time than specified, the Government reserves the right to award whether in accordance with the requested schedule or in accordance with the earlier schedule offered by the contractor. If a contractor offers a longer delivery than that requested, the Government may award based on that schedule. If the contract offers no other delivery schedule, the delivery requested shall apply.

6. Delivery:

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

6.2. The Government may terminate this contract in whole or in part if the contractor fails to meet the required delivery schedule. The Contractor shall be liable for a fixed, occurring amount until the Government may reasonably obtain delivery of similar supplies. The contractor shall not be charged with damages when the delay in delivery arises out of causes beyond the control and without the fault or negligence of the contractor.

6.3. Delivery date and time specified may be adjusted by the Contracting Officer. The Contractor will be notified of this change at least seven (7) days prior to the original or adjusted delivery date.

6.4. DELIVERY LOCATION:

Radiopharmaceuticals shall be delivered to:

(The Hot Lab) located within the Nuclear Medicine Department PVAHCS 650 E. Indian School Rd, Room A-0512B Phoenix, AZ 85012

6.5. DELIVERY COMMITMENT: Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the Contractor.

6.6. All charges incurred for delivery shall be included in the fee schedule to include fuel surcharges.

6.7. Contractor shall provide on an as-needed basis miscellaneous supplies and/or services including but not limited to the following:

a) OSHA compliant monitoring devices.

b) Dose Calibrator calibration.

The C&A requirements do not apply, and that a Security Accreditation Package is not required.