6505--Brand Name Xofigo Ra 223 NDC 50419-0208-01 F18 (Sodium Floride) NaF, NDC 40028-0512-30 F18 (Fludeoxyglucose) FDG, NDC 40028-0511-30

Statement of Work 3

Statement of Need

Client

Philadelphia Veterans Affairs Medical Center

Job Name

Radiopharmaceutical Xofigo Radium 223 Dichloride

NaF (Sodium Fluoride) 40028-0512-30 (5-10 mCi per dose)

FDG (Fludeoxyglucose) 40028-0511-30 (10-100 MCI/ML) INJ

Requested by

Nuclear Medicine Service

From

Gerald Watts, Program Analyst

Summary

CMCVAMC requires a licensed vendor by the Nuclear Regulatory Commission to provide radiopharmaceuticals and calibration sources for the Nuclear Medicine Department. These radiopharmaceuticals are required for imaging procedures. The Calibration sources are required for equipment quality control testing. This particular product, Xofigo, also known as Radium 223, is an injection that is used to treat prostate cancer that is resistant to medical or surgical treatments that has spread to the bones. Also F18 NaF Fludeoxyglucose (FDG) F18 radiopharmaceutical (10-20 mCi per dose) and Sodium Fluoride (NaF) F 18 (5-10 mCi per dose) These items are to be delivered directly to the Diagnostic Imaging section of Nuclear Medicine (secured receiving area), room 3A101B, Philadelphia Veterans Administration Medical Center, Department of Veterans Affairs, 3900 Woodland Avenue, Philadelphia, Pennsylvania 19104.

Project Scope

This SOW covers the following activities and deliverables. The vendor agrees to perform these services with the standard of care, skill, and diligence normally provided by a professional organization in the performance of similar services. It is understood that the contractor must perform the services based, in part, on information furnished by this Medical Center; however, the vendor is given notice that the Medical Center will be relying on the accuracy, competence and completeness of the contractor s services in utilizing the results of such services.

The Nuclear Medicine Staff of CMCVAMC, when needed for next day delivery during work hours will place all orders daily. There may be orders placed during other than normal working hours, to be delivered within a 45-minute window for an emergency. The vendor must be able to fulfill this requirement. All items delivered to the Nuclear Medicine department as specified above. CMCVAMC will require credit statements (itemized returned doses) and monthly invoices. Electronic daily dose tracking systems should be available for the Medical Center s use in certifying and tracking per patient doses delivered.

DELIVERABLES:

Xofigo National Drug Code: 50419-0208-01 Estimated qty. 4500

F18 NaF (Sodium Fluoride) National Drug Code: 40028-0512-30 Estimated qty. 1800

F18 FDG (Fludeoxyglucose) National Drug Code: 40028-0511-30 Estimated qty. 165

The contractor shall have available an adequate supply of contract products to meet the requirements of the CMCVAMC Healthcare System.

The contractor shall label all unit doses of delivered radiopharmaceuticals, with the amounts, preparation time, expiration time, date, etc., and provide a bar labeled insert to allow scanning data into the nuclear medicine information management system (NMIS). If the Contractor s system varies from our current (Pinestar) NMIS information system, the Contractor shall provide their system as well as data migration, technical support and training of staff on its use at no additional price to the government.

All packaging of radioactive material MUST BE clearly labeled RADIOACTIVE with the proper class and exposure levels on the outside of the shipping container.

The contractor shall perform all quality control procedures as required by Federal and State regulatory agencies.

The contractor shall meet all Nuclear Regulatory Commission, Department of Transportation, NHPP, FDA, OSHA and all other agency rules and Regulations (Federal and State).

Radiopharmaceutical Returns for Credit:

The Contractor shall be responsible to accept returns for full credit toward future orders only 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).

Contractor shall invoice at least once per month showing period covered, billing date, name of preparation, quantity and amount.

Schedule

Normally authorized VA Nuclear Medicine personnel shall place orders during the normal workday, and first delivery shall be received no later than 08:00 am the following workday to the CMCVAMC Nuclear Medicine Department s secure location room 3A101B.

Depending on Medical Center patient care requirements, the contractor shall provide routine delivery and pick-up as many times as required by the CMCVAMC.

The delivery order shall include the following information:

Contract item(s) and quantity, time(s) of delivery, and applicable VA order number.

Authorized CMCVAMC Personnel via telephone, fax, or e-mail shall only place orders. Contractor agrees to accept unused radiopharmaceuticals and provide reimbursement per unit dose applicable towards future orders.

After award the CMCVAMC will furnish the name(s) of Nuclear Medicine personnel to the vendor who are authorized to place orders against the Contract.

The Contractor will be furnished with a copy of the user s license as per Nuclear Regulatory Commission guidelines.

Same-Day Delivery

Same-Day Delivery requires delivery and receipt at the CMCVAMC Nuclear Medicine department no later than 2 hours after order is placed during normal business hours. Nuclear Medicine normal business hours are considered Monday through Friday: 6:30 am 4:30 pm except Federal Holidays.

The following are Federal Holidays:

New Year s Day

Martin Luther King, Jr. Day

President s Day

Memorial Day

Independence Day

Labor Day

Columbus Day

Veteran s Day

Thanksgiving Day

Christmas Day

Pricing

Items will be in unit dose, daily, and on an as needed basis in accordance with patient requirements.

Key Assumptions

All annual quantities are estimates, contractor will only be paid for items and quantities ordered and delivered.