RFI 36C26225Q0575-Anorectal Catheter.docx

THIS REQUEST FOR INFORMATION (RFI) 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.

RFI/SOURCES SOUGHT DESCRIPTION

This is NOT a solicitation announcement. This is a RFI Notice only. The purpose of this RFI Notice is to gain information about potential qualified sources and their size classification relative to NAICS 334510 (size standard of 1,250 Employees). Responses to this RFI will be used by the Government to make appropriate acquisition decisions. After review of the responses to this RFI Notice, further RFIs and/or a solicitation or other announcements may be published.

The Department of Veterans Affairs (VA) is seeking information on and sources capable of providing an anorectal catheter for the VA Long Beach Healthcare System and that can address the draft salient characteristics described below.

Brand-Name Product Information:

Manufacturer: Medtronic

Manoscan AR Catheter REG X1

1 EACH

SRV-HRMARCATH-EXW

AR CATHETER EXTENDED WARRANTY 1 YEAR

1 EACH

Equal-to-Product Information:

Main component(s): Anorectal Catheter Possible Capabilities: See the draft salient characteristics below.

The VA Long Beach Healthcare System currently utilizes the Medtronic ManoScan Anorectal Manometry System and Medtronic Manoscan Anorectal Catheters. It is seeking a backup anorectal catheter that meets the following minimum requirements:

1) Anorectal (AR) catheter must be natively compatible with the Medtronic ManoScan Anorectal Manometry System.

a. Must be compatible with the system’s software that assists with providing analysis of manometry results.

2) AR catheter must use pressure sensing technology.

3) AR catheter must offer high resolution manometry.

4) Must be capable of assessing and quantifying normal functions of the anal sphincter and rectum.

5) Must be capable of assessing pelvic floor defecation disorders (e.g., fecal incontinence, constipation).

6) Must allow the provider to visualize anorectal events.

7) AR must come with disposable sheaths.

The list of draft characteristics is intended to be descriptive, not restrictive, of the supplies and/or services that are required.

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 draft salient characteristics described below. For instances where your company cannot meet the draft salient characteristic(s), please explain. For instances where your company can meet the draft salient characteristic(s), please show how your company meets/exceeds each requirement.

(2) Please review the list of draft salient characteristics 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 draft salient characteristics?

(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, or modify the items requested in any way? If you do, state how and what is altered, assembled, or 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? If you are unsure, please state the country of origin for each item.

(12) What is your lead time to deliver all items?

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

(14) 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).

(15) 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.

(16) 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.

(17) Please provide your SAM.gov Unique Entity ID number.

Responses to this notice shall be submitted via email to Bridgett.Sharma@VA.gov. Telephone responses will not be accepted. Responses must be received no later than Monday, March 10, 2025, by 4:00 PM PT.

All responses to this RFI/Sources Sought will be used for planning purposes only. Responses to this RFI/Sources Sought Notice 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 because of the information provided from this RFI, all interested parties must respond to the specific posting separately in accordance with the specifications of that announcement.