36C25027Q0052.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 10 6100 Oak Tree Boulevard Suite 490 Cleveland OH 44131-6969

POINT OF CONTACT*

Contracting Officer Robert Blasko Robert.Blasko@va.gov no phone calls

PLACE OF PERFORMANCE

of the

Statement of Work

Cleveland and Kent Ohio

POSTAL CODE

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

See attached document: SOW FY 27 Kent Low Energy RP Cleveland and Kent - Draft.

SOURCES SOUGHT NOTICE (36C25027Q0052)

Low Energy Radiopharmaceuticals (Non-FDG F-18 Agents), Unit Doses VA Northeast Ohio Healthcare System (Cleveland, OH) and VA Kent Imaging and Infusion Center (Kent, OH)

to: Robert.Blasko@va.gov

1. PURPOSE / DISCLAIMER

This is a Sources Sought Notice (SSN) issued for market research purposes only in accordance with FAR Part 10. It is NOT a solicitation, a request for proposal, a request for quotation, or an invitation for bid, and it does not commit the Government to issue a solicitation or award any contract. The Government will not pay for any information submitted in response to this notice, and responses will not be returned. Submitting a response does not guarantee participation in any future solicitation.

The purpose of this notice is to identify qualified sources — including the extent of participation by Service-Disabled Veteran-Owned Small Businesses (SDVOSBs), Veteran-Owned Small Businesses (VOSBs), and other small business concerns — capable of meeting the requirement described below. Responses will assist the Government in determining the appropriate acquisition strategy (including any Veterans First / Rule of Two set-aside determination under VAAR 819.70) and will be used to support acquisition planning under FAR Part 10 and VAAR Part 810.

This requirement is being conducted under the VA's health-care-resources sharing authority at 38 U.S.C. 8153 and Public Law 104-262.

2. BACKGROUND AND SCOPE

The VA Northeast Ohio Healthcare System and the VA Kent Imaging and Infusion Center require unit-dose, patient-specific low energy radiopharmaceutical products (non-fluorodeoxyglucose F-18 agents) to support routine (non-emergent) and emergent diagnostic nuclear medicine imaging and limited therapeutic procedures.

All doses must be compounded and calibrated by or under the supervision of a certified Nuclear Pharmacist and prepared within the required guidelines of the Board of Pharmacy, specifically USP <797> and USP <825> as appropriate. The contractor must follow generally accepted industry standards and the regulations of the applicable governing bodies, which may include the Society of Nuclear Medicine and Molecular Imaging (SNMMI), the Food and Drug Administration (FDA), the Nuclear Regulatory Commission (NRC), the Centers for Disease Control and Prevention (CDC), the United States Pharmacopeia (USP), and The Joint Commission (JC).

Delivery requirement: The contractor must support both routine and emergent orders (Emergencies). Emergencies may be requested during and outside of regular work hours (Monday through Friday, 06:30 a.m. – 4:30 p.m.) and require delivery within 120 minutes after receipt of a phoned, faxed, or electronic order from the VA. The VA also requires prompt processing of Tc-99m tagged white blood cell (WBC) orders. Quantities are estimates and may vary based on patient demand.

3. REQUIRED LICENSURE STATEMENT

Interested parties must already possess all licenses, registrations, and authorizations required to receive, possess, compound, prepare, transport, distribute, and dispose of the radioactive byproduct material / radiopharmaceutical isotopes described in this notice, and must be regularly established in the business of providing radionuclides. At a minimum, respondents must hold a current, unrevoked Nuclear Regulatory Commission (NRC) and/or applicable Agreement State radioactive materials license authorizing production and distribution of radiopharmaceuticals for human administration, and the authority to receive and dispose of radioactive waste, together with all applicable FDA, U.S. Department of Transportation (DOT), and state and local authorizations. Respondents should confirm they currently hold such licensure (and, where applicable, identify the issuing authority and license type) as part of their response. Respondents are not required to submit the full license with this SSN but must affirmatively state that current, valid licensure is in place; copies may be required at the solicitation/award stage.

4. ESTIMATED REQUIREMENT (ANNUAL ESTIMATES)

The following unit-dose radiopharmaceutical products are required. Quantities are annual estimates based on historical usage for one year and may vary based on patient demand.

Products must be labeled with the radiopharmaceutical identity, amount/activity, concentration, preparation time, calibration time, total volume, expiration date and time, and must include a bar-code label to facilitate scanning into a Nuclear Medicine Information System (NMIS). Each syringe, vial, syringe shield, and vial shield must be correctly labeled.

5. INFORMATION REQUESTED FROM RESPONDENTS

Interested and capable firms are invited to submit a response demonstrating their ability to meet this requirement. Responses must include ALL of the following:

1. Manufacturer Authorized Distribution Letter(s) — documentation establishing the respondent's authorization to distribute the applicable radiopharmaceutical product(s) (e.g., authorized distributor/dealer letter(s) from the manufacturer(s)).

2. Manufacturer's Name(s) — identify the manufacturer(s) of the radiopharmaceutical product(s) the respondent would supply.

3. Business Size and Socioeconomic Status — state whether the firm is a large or small business under NAICS 325412 (1,300-employee size standard), and identify all applicable socioeconomic categories (e.g., SDVOSB, VOSB, 8(a), HUBZone, WOSB, SDB, or other). SDVOSBs/VOSBs must be certified in the SBA Veteran Small Business Certification program (via the SBA Search for Certified Businesses (SBS)).

4. Ability to Provide ALL Items — state clearly whether the firm can provide ALL of the items listed in Section 4. If the firm can provide only a portion, identify specifically which item(s) it can and cannot supply.

5. GSA / NAC / SAC Availability — state whether the item(s) are available on a GSA Schedule, a VA National Acquisition Center (NAC) contract, or a VA Strategic Acquisition Center (SAC) / MSPV contract vehicle, and provide the applicable contract number(s) if so.

6. SAM Unique Entity Identifier (UEI) — provide the firm's SAM.gov UEI. Respondents must be actively registered in SAM.gov (www.sam.gov).

7. Current Licensure Confirmation — an affirmative statement that the firm currently holds all required NRC and/or Agreement State, FDA, and DOT licenses/authorizations to receive, compound, prepare, transport, distribute, and dispose of the radiopharmaceutical isotopes described herein (see Section 3), including the issuing authority and license type where applicable.

8. Positive Acknowledgement of Delivery Capability — a positive, affirmative statement that the firm can deliver in accordance with ALL SOW requirements, including the ability to fulfill emergent orders within 120 minutes of receipt to both the Cleveland and Kent locations, and to provide unit doses compounded/calibrated by or under a certified Nuclear Pharmacist in accordance with USP <797>/<825> and all applicable NRC/FDA/DOT/state regulations. Respondents are encouraged to identify the location(s) of the radiopharmacy(ies) from which they would service both sites.

Additional information requested (optional but helpful): company name, address, point of contact (name, title, phone, email); a brief capability statement; and any relevant prior experience providing unit-dose radiopharmaceuticals to federal or commercial healthcare customers.

6. SUBMISSION INSTRUCTIONS

· Response due date/time: 9:00 AM Eastern Time, Tuesday, November 3, 2026. Responses received after this date and time may not be considered.

· Format: Submit responses electronically to the Contracting Officer / Contract Specialist identified in the SAM.gov posting (Robert.Blasko@va.gov) . Reference this Sources Sought Notice number (36C25027Q0052) in the subject line.

· Page/content: Address each item in Section 5, in order. Capability statements should be concise.

· Questions: Direct any questions to the point of contact listed in the SAM.gov posting (Robert.Blasko@va.gov) prior to the response due date.

7. IMPORTANT NOTES

· This notice does not restrict the Government to any particular acquisition approach. Based on the responses received, the Government will determine whether the requirement can be set aside for SDVOSBs, VOSBs, or other small business concerns consistent with the Veterans First Contracting Program (VAAR 819.70) and the Rule of Two, or whether another acquisition strategy is appropriate.

· Respondents are advised that the Nonmanufacturer Rule (13 CFR 121.406) and Limitations on Subcontracting (FAR 52.219-14 / 52.219-33) apply to any resulting SDVOSB/VOSB set-aside or sole-source award above the micro-purchase threshold. Respondents should be prepared to address their status (manufacturer vs. nonmanufacturer) under these rules.

· All prospective offerors must be registered in SAM.gov to be eligible for any resulting award.

· The applicable Buy American Act / Trade Agreements Act provisions will apply to any resulting solicitation; respondents may be required to provide a Buy American Act certificate and country-of-origin information at the solicitation stage.

THIS IS A SOURCES SOUGHT NOTICE / MARKET RESEARCH ONLY — NOT A SOLICITATION.

Sources Sought Notice