36C26219Q1292-009.docx

STATEMENT OF WORK

1. SCOPE

All Radiopharmaceutical Supplies shall be provided in accordance with the terms and conditions, and provisions of this solicitation for the base year period of October 1, 2019 thru September 30, 2020 with the Government’s option to extend the contract for four (4) additional one-year periods. 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.

PARTICIPATING VA HEALTHCARE SYSTEM:

VA Loma Linda Healthcare System 11201 Benton Street Loma Linda, CA 92357

2. ROUTINE ORDERS

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

3. EMERGENCY ORDERS

An emergency delivery requires same day delivery and with the time specified during the placement of order.

4. LIST OF SUPPLIES

Liquid Scintillation

C-14 Urea Capsule

F-18 Sodium Fluoride

Gallium-67

TI-201 Thallous Chloride

Dimercaptosuccinic Acid 99mTc-DMSA

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 LOMA LINDA HEALTHCARE SYSTEM (VALLHCS):

Delivery Location – Nuclear Medicine Section, Imaging Service. Main hospital, 4th Floor, Room 4E15, Extension 2669.

Normal Work Hours – 8:00am to 4:00pm, Monday through Friday Instruction – 1) Delivery shall be next business day.

6. UNIT DOSE ITEMS

For unit-dose items, products shall be pre-drawn into a syringe, calibrated and delivered at time specified when ordered. The word “Dose” represents the maximum size potency per unit price; however, order may be less.

7. 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.

8. QUALITY ASSURANCE

The quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than + or – 10% for therapeutic doses; = or – 20% for imaging doses at the time of calibration, from the quantities specified.

The Contractor will perform all quality control procedures on each radiopharmaceutical according to applicable requirements of licensing authorities and other regulating bodies. A copy of the results of the quality control procedures must be made available to VALLHCS upon request. In the event that a quality control or material defect is suspected and/or detected by the Contracting Officer Representative (COR), the Contractor will be requested to provide any consultation necessary to alleviate any said suspicion and/or defect by the following:

a. Provide technical expertise in calibration.

b. Provide professional examination of product; submit results and recommendations to the Contracting Officer.

c. Make expedient replacement of any product suspected of being deficient.

d. The Contractor shall make quality control records available to VALLHCS upon written request from the Contracting Officer

e. The Contractor must provide waste disposal at no additional charge of used radioactive dose syringes, vials, etc.; unless otherwise stipulated or prohibited by licensure or regulatory requirements.

f. The Contractor shall provide any additional technical support deemed necessary for the technical staff, physicians, and patient education.

g. Any recalled dose for any reason shall be credited to the Government for the full amount.

h. Any individual doses shall be traceable to the original elution if requested by the Government as per VISN 22 pharmacy standards and regulations.

i. Any dose deemed below standard by the facility shall be credited toward the account. This shall be determined by the Authorized User or COR.

j. Substitutions or Generic Brands may only be used with the express permission of the facility.

k. Items shall be bar-coded and be compatible with the existing NMIS System.

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.

The Contractor shall be responsible for all costs incurred for any radiopharmaceutical and nonradioactive items contracted must find alternate supplier for the contracted items.

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

A radio-pharmacist in the employ of the successful Contractor must be available to:

a. Set-up the quality assurance program on the radiopharmaceutical preparations required by Food and Drug Administration (FDA), Nuclear Regulatory Commission (NRC), United States Pharmacopeia (USP), and the Joint Commission.

b. Act as a reference source concerning questions on the regulation of radiopharmaceuticals.

c. Provide reference services for research drugs and radionuclides under research protocols.

d. Provide instruction (continuing education) to the technologists on new changes in radiopharmaceutical products and availability.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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.

15. 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.

16. 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.

17. 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.

18. SMOKING POLICY

Smoking is permitted only in designated areas.