6505--Axumin (fluciclovine F 18 Injection)

Statement of Need

The Corporal Michael J. Crescenz VA Medical Center s (CMCVAMC) Nuclear Medicine department requires a licensed vendor by the Nuclear Regulatory Commission to provide the radiopharmaceutical drug Axumin (fluciclovine F 18 Injection) and calibration sources. This radiopharmaceutical drug is required for a new imaging procedure that will be offered to Veterans. The Calibration sources are required for equipment quality control testing. Axumin injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment. This item is to be delivered directly to the Diagnostic Imaging section of Nuclear Medicine (secured receiving areas), room 3A101B, Philadelphia Veterans Administration Medical Center, Department of Veterans Affairs, 3900 Woodland Avenue, Philadelphia, Pennsylvania 19104.

Project Scope

This Statement of Need overs 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. Only the Nuclear Medicine department s authorized Staff of the 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

Unit per does

Axumin (Fluciclovine F 18)

The contractor shall have available an adequate supply of contract product 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:

Product ordered or shipped in error

Product damaged in shipment

Concealed shipping damages

Recalled product

Outdated product in unopened, original container (specifically authorized for return by manufacture).

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

Ordering Information

Only authorized CMCVAMC 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 Nuclear Medicine Department 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 radiopharmaceutical and provide reimbursement per unit dose applicable towards future orders.

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

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

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

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