36C25919Q0294-001.pdf

STATEMENT OF WORK

SUPPLIER OF F18 AXUMIN™ FOR

PET/CT IMAGING OF PROSTATE TUMORS

MAY 24, 2019

I. OBJECTIVES:

The Contractor will be required to provide F18 Axumin™ for prostate tumor imaging to the VAMC Oklahoma City (VAMC OKC), 921 NE 13TH ST, Oklahoma City, Ok, 73104.

Services will include, but are not limited to the following:

II. QUALIFICATIONS OF CONTRACTOR:

A. The Contractor must be licensed to prepare and distribute radiopharmaceuticals by the

US Nuclear Regulatory Commission (USNRC) or Agreement State. A copy of the license must be provided to the VAMC OKC.

B. The Contractor must employ licensed Nuclear Pharmacists to oversee daily operations. A license for each pharmacist must be provided to VAMC OKC.

C. The Contractor must be financially responsible and able to provide past performance evidence of their reliability, ability, experience, equipment, facilities and personnel to provide prompt satisfactory service.

III. HOURS OF OPERATION:

A. Contractor services shall be routinely required during the hours of 0700-1630, Monday through Friday excluding federal holidays.

IV. REGULATORY REQUIREMENTS:

A. The Contractor shall meet all USNRC/Agreement State, Department of Transportation, FDA, OSHA, Pharmacy/Pharmacist licensing (Federal and State), as well as any applicable Joint Commission requirements.

B. Current licensing documents must be provided to VAMC OKC C. Regulatory inspection reports must be provided to VAMC OKC when they occur. This shall include any Notices of Violation and the corrective actions taken by the Contractor.

V. ORDERING PRODUCT:

A. Routine next day orders shall be placed by 1530hrs the day before.

B. The preferred method of next day orders is telephone or electronically via our ec2

Software Solutions (Formally Pinestar) Nuclear Medicine Information System (NMIS).

C. Orders shall be made by Nuclear Medicine Technologists designed by the Contracting Officer Representative (COR). The names of these individuals shall be provided to the Contractor.

VI. DELIVERY OF PRODUCT:

A. All packages containing radioactive material shall be labeled and shipped in accordance with Title 49, Code of Federal Regulations Part 172 and 173. Compliance with all applicable regulatory bodies, including FDA and US DOT is requisite.

B. Routine deliveries shall be made on an as needed basis, during normal working hours, by the contractor at no additional cost to VAMC OKC.

C. Delivery shall be made during normal working hours to Room 1G 114 located inside the Radiation Oncology Department.

VII. PRODUCT DESCRIPTION:

A. The radioisotope shall be delivered as unit doses in shielded containers.

B. Each unit dose shall be meet the labeling requirements outlined in USNRC regulations outlined in 10 CFR Part 35.

• Customer name

• Ordering Physician

• Procedure

• Radiopharmaceutical Name

• Calibration Activity

• Calibration date/time

• Manufacturer

• Volume

• mCi/ml

• Prescription number

• Lot number

• Expiration Date/time

C. An additional label containing the above information shall also be affixed to the dose syringe or other container being utilized.

D. Each unit dose must contain a bar code so that dose information can be scanned into the VAMCM Nuclear Medicine Information System. (NMIS)

VIII. QUALITY CONTROL:

A. The Contractor shall perform all necessary quality control procedures in accordance with Title 10 CFR Part 35 and any other Federal/State regulations that are applicable to the radiopharmacy industry.

B. Quality Control results will be furnished to VAMC OKC upon request.

IX. PACKAGING AND MARKING:

In accordance with accepted commercial practice and nuclear regulatory requirements.

A. Contractor shall label all unit doses of delivered radiopharmaceutical with the amount, preparation time, expiration time and date.

B. All packages containing radioactive material must be labeled and shipped in accordance with Title 49, Code of Federal Regulations Part 172 and 173. Compliance with all applicable regulatory bodies, including FDA and US DOT is requisite. An additional label shall be affixed to each syringe, vial, or other container used to hold a radioactive drug to be transferred for commercial distribution. The label must include the radiation symbol and the words "CAUTION, RADIOACTIVE MATERIAL" or "DANGER, RADIOACTIVE MATERIAL" and an identifier that ensures that the syringe, vial, or other container can be correlated with the information on the transport radiation shield label.