36C26219Q1355-001.docx

STATEMENT OF WORK

1. SCOPE

Manufacturing and delivery of sterile/aseptic, USP 797 compliant, low enriched uranium (LEU) radiopharmaceuticals for diagnosis and treatment of patients receiving services at VA San Diego Healthcare System Nuclear Medicine Service. Delivery services must meet all DOT requirements for shipment and delivery of radioactive drugs. Stat delivery services (within 1 hour) must be available 24hrs/day 365 day/year. Company providing services must provide dose labels compatible with the Nuclear Medicine information System( NMIS) computerized radiopharmacy database. Company must provide storage, preparation, labeling and delivery of research radiopharmaceuticals as requested. Radiopharmaceuticals Supply shall be provided in accordance with the terms and conditions, and provisions of this contract for year October 1, 2019 thru September 30, 2020.

PARTICIPATING VA HEALTHCARE SYSTEM:

VA San Diego Healthcare System 3350 La Jolla Village Drive Nuclear Medicine Service San Diego, CA 92161

2. ROUTINE ORDERS

Routine orders require delivery the next business day, unless specified elsewhere in this contract.

3. EMERGENCY ORDERS

Stat delivery services (within 1 hour) must be available 24hrs/day 365 day/year.

4. LIST OF SUPPLIES

SUBTOTAL (Products)

5. DELIVERY LOCATION, NORMAL WORK HOURS AND INSTRUCTIONS:

· Time of delivery specified or mutually agreed to at the time of receipt of telephone orders shall become mandatory upon the Contractor’s acceptance to commitment.

· Delivery of supplies by the scheduled time will be complete except as otherwise authorized by Government personnel.

· If the Contractor cannot make delivery and an outside source must be utilized, the Contractor will be responsible for paying the difference in cost.

VA SAN DIEGO HEALTHCARE SYSTEM (VAGLAHCS):

Delivery Location – Nuclear Medicine Service, Main Hospital, 4 West, 4th Floor Normal Work Hours – 7:00am to 4:00pm, Monday through Friday

6. PACKAGING AND MARKING

a) The contractor shall package, mark and transfer all radioactive material in accordance with all applicable local, state, and federal regulations.

b) Items must be adequately packaged to prevent damage during shipping, handling, and storage.

c) All outer packages must contain the complete purchase number, obligation number and contract number in addition to the shipping address. The purchase number and obligation number will be provided by the individual at the time of ordering. The contract number will be provided upon notice of contract award.

d) Packaging List: A packing list/slip shall be enclosed with each shipment indicating the purchase/obligation and delivery order number, contract number, items/quality ordered and items/quality shipped.

e) The Contractor shall provide MSDS sheets (Material Safety Data Sheets) and updates as necessary on all delivered products.

f) The Contractor shall meet all requirements of regulatory agencies for deliveries of radioactive isotopes between facilities and shall strictly adhere to these requirements. Deliveries not properly handled according to regulations will not be accepted.

g) In the event of a manufacturer or pharmacy recall or quality assurance failure, the Contractor shall notify VASDHCS Nuclear Medicine Department immediately.

7. RECALLED AND DEFECTIVE PRODUCTS

The Contractor will immediately notify the Contracting Officer of any recalls of product or other important product safety issues. As appropriate, the Contractor will replace and/or reimburse recalled / defective products at no cost to the Government. The Contractor may be liable for costs of processing recalls, i.e. administrative and clinical services to replace recalled / defective products.

8. CERTIFICATION AND LICENSING REQUIREMENT

Pharmacists employed by the Contractor shall be an authorized user on the Contractor’s Radioactive Materials License. The Pharmacy of the Contractor shall be licensed by the State of Operation and by the Nuclear Regulatory Commission or Agreement State Agency.

9. SAFETY GUIDELINES AND REQUIREMENTS

Delivery personnel shall be trained in Radiation Safety Techniques, Nuclear Regulatory Commission, Joint Commission safety guidelines and Department of Transportation requirements.

10. NATIONAL HOLIDAYS OBSERVED BY THE GOVERNMENT

The President of the United States of America may declare additional days as a Federal holiday, and if so, this holiday will automatically be added to the list above. When a holiday falls on a Sunday, the following Monday shall be observed as a Federal holiday. When a holiday falls on a Saturday, the preceding Friday shall be observed as a Federal Holiday.

11. CONTRACTOR DELIVERY PERSONNEL

All contractor personnel are required to wear clothing bearing the name of the Contractor and wear a badge that has the Contractor name. Contractor personnel must have a picture I.D. and must be able to speak English.

12. PARKING AND SPEED LIMIT

Park only in areas designated by the Contracting Officer Representative (COR) or otherwise directed by Police and Security Service personnel. The Contractor shall display on each of its vehicles the company name in a size that is clearly visible. Upon receipt of award, the Contractor shall submit a list of employees and vehicles to the COR of each facility. The Contractor shall conform to the speed limit set at each Government facility. Should Contractor personnel receive a citation for parking, speeding or other infraction from VA Security, the offenses will be handled in Federal Court as they are Federal offenses.

13. PLACEMENT OF VERBAL ORDERS

Contractors shall provide on a separate sheet of paper, the name, location, and telephone number of the office where the participating VA facility will call to place orders.

14 INVOICE AND PAYMENT

No advanced payments will be authorized. The contractor shall submit invoices on a monthly basis. The invoice must have at a minimum, the contract number, assigned purchase order, assigned obligation number, date order was placed, date order was shipped, and any additional necessary detailed information to identify service rendered. Payment on invoice may be delayed in invoice(s) are not completed properly.

15. PERSONNEL POLICY

The parties agree that the contract personnel working this contract shall not be considered VA employees for any purpose and shall be considered employees of the contractor.

16. SMOKING POLICY

Smoking is permitted only in designated areas.