36C25526Q0009 Sources Sought.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office (NCO) 15 3450 S 4th Street Trafficway Leavenworth KS 66048

POINT OF CONTACT*

Contract Specialist Stephen Parrott Stephen.Parrott@va.gov 913-946-1966

This Sources Sought Notice is for planning purposes only and shall not be considered as an invitation for bid, request for quotation, request for proposal, or as an obligation on the part of the Government to acquire any products or services. Your response to this Sources Sought Notice will be treated as information only. No entitlement to payment of direct or indirect costs or charges by the Government will arise because of contractor submission of responses to this announcement or the Government use of such information. This request does not constitute a solicitation for proposals or the authority to enter negotiations to award a contract. No funds have been authorized, appropriated, or received for this effort.

The information provided may be used by the Department of Veterans Affairs in developing its acquisition approach, statement of work/statement of objectives and performance specifications. Interested parties are responsible for adequately marking proprietary or competition sensitive information contained in their response. The Government does not intend to award a contract based on this Sources Sought Notice or to otherwise pay for the information submitted in response to this Sources Sought Notice.

The purpose of this sources sought announcement is for market research to make appropriate acquisition decisions and to gain knowledge of potential qualified Service-Disabled Veteran Owned Small Businesses, Veteran Owned Small Businesses, 8(a), HubZone and other Small Businesses interested and capable of providing the services described below.

Documentation of technical expertise must be presented in sufficient detail for the Government to determine that your company possesses the necessary functional area expertise and experience to compete for this acquisition.

Responses to this notice shall include the following:

(a) Company Name

(b) Address

(c) Point of Contact

(d) Phone, Fax, and Email

(e) UEI number

(f) Cage Code

(g) Tax ID Number

(h) 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.)?

(i) Is your company considered small under the NAICS code identified under this SSN/RFI?

(j) Are you the manufacturer, distributor, or an equivalent solution to the items being referenced above?

(k) 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).

(l) 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?

(m) 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 subcontracted work.

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

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

(p) Please provide general pricing of your products/solution for market research purposes

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

(r) Please provide general pricing of your products/solution for market research purposes

(s) Must provide a capability statement that clearly addresses the organizations qualifications and ability to perform as a contractor for the work described below.

Important information: The Government is not obligated to, nor will it pay for or reimburse any costs associated with responding to this source sought synopsis request. This notice shall not be construed as a commitment by the Government to issue a solicitation or ultimately award a contract, nor does it restrict the Government to an acquisition approach. The Government will in no way be bound to this information if any solicitation is issued.

Any response to this source selection from Interested parties must be received NLT 09/29/2025, 0800 AM CST.

Attention: Stephen Parrott, Contract Officer Email: stephen.parrott@va.gov Please reference 36C25526Q0009 Radiopharmaceuticals PSMA Doses EKHCS VAMC in the subject line.

Please provide your Unique Entity ID so that your organization can be identified in SAM.GOV and VetBiz if organization is claiming SDVOSB preference.

Only organizations with an active SAM.GOV account can be considered.

Utilize this link to either start a new registration or to renew the organization’s registration.

https://sam.gov/content/home

STATEMENT OF WORK

Radiopharmaceutical- PSMA PET/CT Imaging Agent VA Eastern Kansas- Topeka

Description/Specifications

1. This SOW outlines the need for VA Eastern Kansas and the procurement of radioactive F-18 injection. The radiopharmaceutical will be used during imaging using positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. This isotope will identify candidates who are suspected metastasis candidates for initial definitive therapy based on elevated serum prostate-specific antigen (PSA) levels.

2. Contractor agrees to provide F-18 PSMA radiopharmaceuticals as identified in the IGCE and Prices to Nuclear Medicine Departments at Eastern Kansas Healthcare System Colmery O-Neil VA Medical Center at 2200 Gage Blvd., Topeka, KS 66622. Deliveries will be made Monday through Friday from 7:30 am to 3:00 pm. Contractor shall provide emergency deliveries as requested by the VA Nuclear Medicine Departments. Personnel assigned by the contractor to perform services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia.

Description/Part Number*

Estimated Qty.

PSMA F-18

Appx. 2-3 per week per provider order.

3. Deliveries will incorporate sufficient lead or other high-density metal shielding to comply with all applicable federal and/or state standards relating to shipment of radioactive materials. Shipping containers must comply with all federal and state regulations. This will include Department of Transportation (DOT), Department of Energy (DOE), Nuclear Regulatory Commission (NRC), and Interstate Commerce Commission (ICC) regulations and standards.

4. Supplier shall hold a current unrevoked USNRC and/or FDA license to produce and distribute radiopharmaceuticals for human administration, and a license to receive and dispose of radioactive waste. Supplier shall provide a copy of their radioactive material license to the Nuclear Medicine Service at VA Eastern Kansas Medical Center (EKVA) upon commencement of this contract. Supplier shall immediately notify EKVA upon any action, be the USNRC, agreement state, and/or FDA to suspend or modify suppliers. Suppliers shall provide radiopharmaceuticals which have been prepared according to manufacturer’s package inserts.

5. Upon notification of contract award, Contractor will provide, in writing, within ten (10) days, the following information to the VA Medical Center:

a. Contractor’s regular work hours.

b. Contractor’s telephone number for call-in orders during regular work hours.

c. Contractor’s telephone number and instructions for placing “Emergency” orders after contractor’s regular work hours, including weekends.

d. Contractor’s telephone number for expert advice concerning awarded products.

e. Contractor will furnish a statement that any radiopharmaceuticals delivered as “ready-to-use” (individual doses in syringes or vials for single or multiple uses) will have quality control performed by the Contractor, so that the delivered product will comply with the requirements of The Joint Commission (TJC) and/or with the United States Pharmacopeia.

f. Should any changes occur in the above information during contract performance period, contractor will provide updates in writing.

6. Current package inserts of all radiopharmaceuticals supplied under this contract will be shipped to the PET/CT Service at the inception of the contract. If any new and/or updated additions to the package inserts are made available, these will be sent to the Nuclear Medicine Service at VA Eastern Kansas Medical Center.

7. Contractor shall make their radiopharmaceutical quality control records available to the VA Eastern Kansas Medical Center upon written request from the Contracting Officer if needed.

8. Calibration time for each requested radiopharmaceutical is given in the Schedule of item, or if not so indicated, then it will be spelled out in the requirements provided by the Nuclear Medicine Service, otherwise it will correspond to the actual time of delivery.

9. If dosage is given to Contractor, then the quantity of radioactivity must be within the dose provided. If dose is not given in a range, then the quantity of radioactivity for supplied radiopharmaceuticals will not deviate more than ±20%.

10. In the event that a quality control or material defect is suspected and/or detected by any Veterans Affairs COTR, 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 Contacting Officer.

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

Work Hours

The delivery of products provided by this contract shall be furnished by the contractor. The contractor shall not be required, except in case of an emergency, to furnish such products on a national holiday or during non-working hours as described below with the exception of normal next day delivery as described in (1) above and (2) below.

The following terms have the following meanings:

(1) Normal Operating hours of Nuclear Medicine: Monday through Friday, 7:30a.m. to 4:00 p.m.

(2) Normal Next Day Delivery: 7:30a.m.

(3) National Holidays: The ten holidays observed by the Federal Government are:

New Year's Day, Martin Luther King's Birthday, President’s Day, Memorial Day, Independence Day, Labor Day, Columbus Day, Veteran’s Day, Thanksgiving, and Christmas, and any other day specifically declared by the President of the United States to be a national holiday

Delivery Locations

Eastern Kansas Health Care System Colmery O’Neil VA Medical Center Nuclear Medicine Department 2200 Gage Blvd.

Topeka, Kansas 66622 A210/A215 PET/CT- Nuclear Medicine

Personnel Policy The contractor is responsible for all costs, including personnel costs, associated with this contract.

Qualifications Personnel assigned by the contractor to prepare and provide the products covered by this contract shall be nuclear pharmacists, or licensed technologist working under the supervision of nuclear pharmacist licensed in a State, Territory or Commonwealth of the United States or the District of Columbia. The qualifications of such personnel shall also be subject to review by the EKVA Chief of Staff and approval by the EKVA Facility Director.

Contractor Staff, Roles and Responsibilities Must be in compliance with all Nuclear Regulatory Commission (NRC), United States Pharmacopeia (USP), state, local and The Joint Commission (TJC) guidelines.

Sources Sought Notice