6505--Y-90 Resin Microspheres IDIQ

Active

Contract Opportunity

THIS REQUEST FOR INFORMATION (RFI) / SOURCES SOUGHT NOTICE IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES. THIS IS NOT A SOLICITATION.

SUBMISSION OF INFORMATION ABOUT PRICING, DELIVERY, THE MARKET, AND CAPABILITIES IS HIGHLY ENCOURAGED AND ALLOWED UNDER THIS RFI FOR PLANNING PURPOSES IN ACCORDANCE WITH (IAW) FAR 15.201(e).

DISCLAIMER

This RFI is issued solely for information and planning purposes and does not constitute a solicitation. All information received in response to this RFI that is marked as proprietary will be handled accordingly. IAW FAR 15.201(e), 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.

SOURCES SOUGHT/RFI DESCRIPTION

This is NOT a solicitation announcement. This is a Sources Sought Notice / RFI only. The purpose of this Sources Sought Notice / RFI is to gain information about potential qualified sources and their size classification relative to NAICS 325412 (size standard of 1,300 Employees). Responses to this Sources Sought Notice / RFI will be used by the Government to make appropriate acquisition decisions. After review of the responses to this Sources Sought Notice / RFI, further RFIs and/or a solicitation or other announcements may be published.

The Department of Veterans Affairs (VA) is seeking sources capable of providing Yttrium-90 (Y-90) Resin Microsphere Therapy in accordance with the Statement of Work below.

Statement of Work

Introduction: The Department of Veterans Affairs Southern Arizona VA Medical Center (VAMC) is located at 3601 South 6th Avenue, Tucson, Arizona 85723 has a requirement for the radiopharmaceutical Yttrium-90 resin microspheres for the Interventional Radiology Department’s treatment of both primary and metastatic liver malignancies.

Background: The Interventional Radiology Department at the VAMC will be treating patients with primary and metastatic liver disease with Yttrium-90 resin microspheres. VAMC intends to set up a Firm-Fixed Price Indefinite-Delivery Indefinite-Quantity (IDIQ) contract for base plus option four (4) years.

Scope: Contractor shall provide all unit dose Yttrium-90 resin microspheres used by Nuclear Medicine and Interventional Radiology, at the VAMC in Tucson, Arizona.

Period of Performance (PoP):

Base: 11/1/2025 – 10/31/2026

Option Year 1 (OY1): 11/1/2026 – 10/31/2027

Option Year 2 (OY2): 11/1/2027 – 10/31/2028

Option Year 3 (OY3): 11/1/2028 – 10/31/2029

Option Year 4 (OY4): 11/1/2029 – 10/31/2030

Place of Performance:

Department of Veterans Affairs

Southern Arizona VA Healthcare System

3601 South 6th Avenue,

Building 38, Nuclear Medicine, Hot Lab

Tucson, Arizona 85723

Deliverables:

PoP

Line Item

Description

Qty

UOM

Base

0001

SIR-Spheres Y-90 resin microspheres

24

EA

Base

0002

SIR-spheres dose preparation

24

EA

Base

0003

Additional prepared dose

12

EA

OY1

1001

SIR-Spheres Y-90 resin microspheres

24

EA

OY1

1002

SIR-spheres dose preparation

24

EA

OY1

1003

Additional prepared dose

12

EA

OY2

2001

SIR-Spheres Y-90 resin microspheres

24

EA

OY2

2002

SIR-spheres dose preparation

24

EA

OY2

2003

Additional prepared dose

12

EA

OY3

3001

SIR-Spheres Y-90 resin microspheres

24

EA

OY3

3002

SIR-spheres dose preparation

24

EA

OY3

3003

Additional prepared dose

12

EA

OY4

4001

SIR-Spheres Y-90 resin microspheres

24

EA

OY4

4002

SIR-spheres dose preparation

24

EA

OY4

4003

Additional prepared dose

12

EA

Order Limitation

Minimum Order Threshold per Delivery Order

$10,000.00

Maximum Order Threshold per Delivery Order

$500,000.00

The quantities cited above are estimated quantities for base and all option periods; quantities are not a contractual statement of precise quantities that the Government will order. The quantities given are estimated only, and no guarantee of their accuracy is either given or implied. The Government will only pay for quantities that are actually ordered and for which the services are fulfilled.

Requirements:

Ordering Requirements:

1. The Contractor shall provide personnel or ordering procedure for orders for Yttrium-90 resin microspheres to be placed during standard hours of care Monday through Friday from 0800 (8:00AM AZT) until 1630 hours (4:30PM AZT), excluding Federal Holidays. Upon the order being placed, the Contractor shall send confirmation to the ordering VAMC official via email.


2. The Contractor shall receive orders for Yttrium-90 resin microspheres from the Nuclear Medicine section of SAVAHCS Radiology Service. The Contractor shall ensure the Nuclear Medicine staff name and contact information that placed the order is included.


3. The Contractor shall calibrate all Radiopharmaceutical doses to ensure proper activity ranges of +/- 10 percent of the specified ordered dose per specific requirements provided by the Nuclear Medicine section based on Nuclear Regulatory Commission guidelines outlined in 10 CFR Part 35 Medical Uses of Byproduct Material.


4. The Contractor shall notify VAMC Nuclear Medicine section immediately should the inability arise to provide Radiopharmaceutical (Yttrium-90) doses by the required date and time.

Delivery Requirements:

1. The Contractor shall ensure all orders are to be delivered by 0730 (AZT) on the day specified or prior to the day specified to ensure proper inventory and receipt of the shipment is done by qualified personnel.


2. The Contractor shall provide a daily packing slip accompanying all Radiopharmaceutical shipments to the Nuclear Medicine section for all orders placed.


3. The Contractor shall ensure that all Radiopharmaceutical doses provided are compounded and calibrated by or under the supervision of a certified Nuclear Pharmacist.


4. The Contractor shall provide courier service that is in accordance with Department of Transportation, Nuclear Regulatory Commission and other applicable regulating authorities enabling the delivery of all Yttrium-90 resin microspheres. All couriers shall be licensed and shall submit all required paperwork in order to be granted access to VAMC.

Additional Requirements:

1. The Contractor shall provide any training or education required to meet commercial standards related to use of the radiopharmaceutical (Yttrium-90) to qualified Nuclear Medicine staff, Interventional Radiology staff, and the Radiation Safety Officer at SAVAHCS.


2. The Contractor shall provide any documentation required to meet commercial standards related to use of the radiopharmaceutical (Yttrium-90) resin microspheres.


3. The Contractor shall obtain, maintain, and provide evidence at the request of the Government, U.S. Food & Drug Administration (FDA) approval of the Yttrium-90 resin microspheres.

Government Responsibilities:

1. The Government shall ensure all routine orders for Yttrium-90 resin microsphere doses will be placed by the VAMC to the Contractor a minimum of three business days prior to treatment and before the clinic close of business via phone or internet. The order will include specified activities of doses and calibration times.

Hours of Work:

Normal business hours are 8 a.m. to 4:30 p.m., Monday through Friday excluding the following federal holidays. A list of Federal Holidays can be found via https://www.opm.gov/policy-data-oversight/pay-leave/federal-holidays/.

If your company is interested and capable of providing the required supplies/services, please provide the information indicated below. Response to this notice should include company name, address, point of contact, size of business pursuant to the following questions:

(1) Submit your capabilities statement illustrating how your organization can/cannot meet the list of SOW requirements. For instances where your company cannot meet the SOW requirement(s), please explain. For instances where your company can meet the SOW requirement(s), please show how your company meets/exceeds each requirement.

(2) Please review the list of SOW requirements and provide any additional feedback or suggestions. If none, please reply as N/A.

(3) 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.

(4) Is your company considered small under the NAICS code identified in this RFI?

(5) Are you the manufacturer, authorized distributor, and/or can your company provide a solution to the required supplies/services described in the list of SOW?

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

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

(8) Limitations on Subcontracting: How does your business ensure compliance with the limitations on subcontracting as outlined in 13 CFR § 125.6?

(9) Are the items you are identifying/providing considered Commercial of the Shelf (COTS) items as defined in FAR Part 2.101 under commercial items?

(10) Non-Manufacturer Rule: If applicable, can you confirm your business complies with the Non-Manufacturer rule? Specifically, does your company: Provide a product from a small business manufacturer or processor? Not exceed 500 employees? Primarily engage in the retail or wholesale trade and normally sell the type of item being supplied? Take ownership or possession of the item(s) with its personnel, equipment or facilities in a manner consistent with industry practice?

(11) Please indicate whether your product conforms to the requirements of the Buy American Act?

(12) What is your lead time to deliver a single unit with all components? Is there scale in lead time with greater quantities? Please elaborate.

(13) What is estimated life span of your solution? What support/services does that entail?

(14) Does your proposed equipment have FDA clearance? Please specify what FDA clearance(s) have been obtained.

(15) Does your organization offer a leasing solution? Please elaborate.

(16) Does your company have a Federal Supply Schedule (FSS) GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract? If so, please provide the contract number(s).

(17) If you are an FSS GSA/NAC/SAC/BPA/NASA SEWP or any other Federal Government contract holder, are all the items/solutions you are providing information about available on your schedule/contract? Please state if all or some items are available on the contract.

(18) 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.

(19) Please provide your SAM.gov Unique Entity ID/Cage Code number.

Responses to this notice shall be submitted via email to Hestia.Sim@va.gov. Telephone responses will not be accepted. Responses must be received no later than Friday, August 1, 2025, by 10AM Pacific Local Time.

All responses to this Sources Sought/RFI will be used for planning purposes only. Responses to this Sources Sought Notice / RFI are not considered a request to be added to a prospective bidders list or to receive a copy of the solicitation. If further RFIs and/or a solicitation or other announcement is issued as a result of the information provided from this RFI, all interested parties must respond to the specific posting separately IAW the specifications of that announcement.

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