36C24420Q1058 – Sources Sought – 3650–Axumin (Fluciclovine F 18 Injection) This sources sought is for Markert Research Only No quotes will be accepted at this time Reference 36C24420Q1058 in subject of email response

Sep 5, 2020 | Sources Sought

Statement of Work 3

This is not a request for quote.
No quotes will be accepted. This Sources Sought is for Market Research purposes only. See instructions on page 3.
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 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. 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.

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.

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.

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


The information identified above is intended to be descriptive, of the brand name Axumin (fluciclovine F 18 Injection) and to indicate the quality of the supplies/services that will be satisfactory. It is the responsibility of the interested source to demonstrate to the government that the interested parties can provide the supplies/services that fulfill the required specifications mentioned above.

Responses to this RFI should include company name, address, point of contact, phone number, and point of contact e-mail, DUNS Number, Cage Code, size of business pursuant to North American Industrial Classification System (NAICS) 325412.

Please answer the following questions:

(1) Please indicate the size status and representations of your business, such as but not limited to: Service-Disabled Veteran Owned Small Business (SDVOSB), Veteran Owned Small Business (VOSB), Hubzone, Woman Owned Small Business (WOSB), Large Business, etc.)?

(2) Is your company considered small under the NAICS code identified under this RFI?
(3) Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above?

(4) If you are a large business, do you have any designated distributors? If so, please provide their company name, telephone, point of Contact and size status (if available).

(4) (a) Describe how your small business takes ownership of the equipment in the manufacturing, assembly or delivery process.

(5) If you re a small business and you are an authorized distributor/reseller for the items identified above or an equivalent solution, do you alter; assemble; modify; the items requested in any way? If you do, state how and what is altered; assembled; modified?

(6) If you intend to subcontract any work on this contract, what portion of the total cost will be self-performed/will be performed by your organization? Please provide estimated detailed percentage breakdowns related to sub contracted work and completion of job.

(7) Does your company have an FSS contract with GSA or the NAC or are you a contract holder with any other federal contract? If so, please provide the contract number.

(8) If you are an FSS GSA/NAC contract holder or other federal contract holder, are the items/solution you are providing information for available on your schedule/contract?

(9) General pricing of your products/solution is encouraged. Pricing will be used for the purpose of market research only. It will not be used to evaluate for any type of award.

(10) Please submit your capabilities in regard to the brand name equipment.

(11) Please review salient characteristics/statement of work (if applicable) and provide feedback or suggestions. If none, please reply as N/A.

(12) Please provide your DUNS number.

This RFI will be conducted in accordance with Federal Acquisition Regulation (FAR) Part 13. Telephone responses will not be accepted. Responses must be received via e-mail to andrew.taylor3@va.gov no later than, 15:00 PM Eastern Standard Time (EST) on September 8, 2020. This notice will help the VA in determining available potential sources only. Reference 36C24420Q1058 in the subject of the email response.

Do not contact VA Medical Center staff regarding this requirement, as they are not authorized to discuss this matter related to this procurement action. All questions will be addressed by the Contracting Specialist, Andrew Taylor.

All firms responding to this Request for Information are advised that their response is not a request for proposal, therefore will not be considered for a contract award.
If a solicitation is issued, information will be posted on the Beta.Sam web site for all qualified interested parties at a later date and interested parties must respond to the solicitation to be considered for award. This notice does not commit the government to contract for any supplies or services. The government will not pay for any information or administrative cost incurred in response to this Request for Information. Information will only be accepted in writing by e-mail to Contracting Specialist at andrew.talor3@va.gov

This RFI is issued solely for information and planning purposes only and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI.

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