6515--STEALTHMERGE ENT NAVIGATION SOFTWARE BRAND NAME ONLY CS: Maureen Sundstrom

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This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This is a Brand Name Only Request for Quote (RFQ), and the solicitation number is 36C26023Q0798. The Government anticipates awarding a firm-fixed price supply order from this solicitation.

This is a solicitation for Medtronic Stealthmerge ENT Navigation System Software. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-04 Effective June 2, 2023.

This solicitation is 100% set-aside for SDVOSB. The associated North American Industrial Classification System (NAICS) code for this procurement is 334510, with a small business size standard of 1250 employees and the PSC is 6515.

All interested companies shall provide quotations, that are Brand name only to Medtronic for the following:

Equipment Needed:

Medtronic Stealthmerge ENT Software

ITEM

PART NUMBER

QUANTITY

PRICE

Stealthmerge ENT Navigation Software

SW 9736155

1

Salient Characteristics:

The equipment must meet at a minimum each of the following:

- MUST BE COMAPTIBLE WITH THE STEALTHSTATION ENT NAVIGATION MACHINE

- MUST HAVE ABILITY TO CREATE SURGICAL PATHWAY BY CREATING ENTRY AND

TARGET POINTS

- SOFTWARE MUST BE ABLE TO CREATE 3D MODELS OF ANATOMY OR PATHOLOGY

AND HAVE ABILITY TO CREATE MULTIPLE MODELS AND BLEND THEM TOGETHER.

- MUST HAVE ABILITY TO FUSE CT IMAGING WITH MRI

- MUST HAVE ATOMATED TOOLS AVAILABLE FOR SKIN, BONE, BRAIN AND BLOOD

VESSELS

- MUST PROVIDE A SIMULATED 3D ENDOSCOPIC VIEW OF THE SINUS

- MUST PROVIDE REAL-TIME FEEDBACK OF ANATOMY AND LOCATION WITHIN THE

PARANASAL SINUSES AND SKULL BASE

- MUST HAVE STEALTHMERGE

- MUST ALLOW SURGEON TO CREATE A PRE-OP PATHWAYS.

- MUST INCLUDE INSTALLATION, TESTING, AND RUN-THROUGH

- MUST INCLUDE SOFTWARE SUPPORT AND MAINTENANCE, ENHANCEMENT

UPGRADES, AND TRAINING

- MUST INCLUDE 6 SURGICAL SUPPORT VISITS

- MUST INCLUDE MEDTRONIC WARRANTY

Place of Delivery:

Department of Veterans Affairs

Puget Sound Healthcare System

1660 S. Columbian Way

Seattle, WA 98108

F.O.B. Destination is the preferred delivery within 30-45 days after placing the order. All deliveries will be coordinated with the Seattle VAMC Point of Contact.

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, Instructions to Offerors Commercial Items ,

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL

52.204-7

System for Award Management (OCT 2018) [all solicitations except when conditions at FAR 4.1102(a) apply] Alternate I (OCT 2018) [when contract is awarded without providing full & open competition due to unusual or compelling urgency, FAR 4.1102(a)(5)

52.204-16

Commercial and Government Entity Code Reporting (AUG 2020)

52.212-3

Offeror Representations and Certifications Commercial Products

52.225-2

Buy American Certificate (Oct 2022) (41 U.S.C. chapter 83)

52.233-3

Service of Protest (SEPT 2006)

(a) Gray market items are Original Equipment Manufacturers (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e., replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable.

(b) Offeror shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e., replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions.

(c) The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items.

(d) Any award made as a result of this solicitation will be made on an All or Nothing Basis.

(e) Offerors are warned against contacting any VA personnel other than the Contracting Officer and Contract Specialist prior to placement of any award made resulting from this RFQ. If such contact occurs and found to be prejudicial to competing contractors, the offeror making such contact may be excluded from award considerations.

(f) All proprietary information shall be clearly and properly marked. If the Offeror submits annexes, documentation, attachments, or the like, not specifically required by this solicitation, such will count against the Offeror s page limitations unless otherwise indicated in the specific volume instructions below.

(g) All information shall be confined to the appropriate file. The offeror shall confine submissions to essential matters, sufficient to define the quote and provide an adequate basis for evaluation. Offerors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each quote.

(End of Addendum to 52.212-1)

2. FAR 52.212-2, Evaluation-Commercial Items : The Government may award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. In accordance with FAR 9.104-2, the special standards of responsibility described below apply to this procurement. Offerors who fail to meet any special standards of responsibility will not be eligible to receive contract award. The following factors shall be used to evaluate offers:

Special Standards of Responsibility: (Per FAR 9.104-2) The following special standards of responsibility apply to this procurement:

SP1: Offeror must be a manufacturer authorized provider for the items provided. A letter from the manufacturer stating as such must be included with any response to this solicitation.

1. Price

(a) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offeror's specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.

10. Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer if has not been completed on SAM.gov. Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/content in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required.

3. All Service-Disabled Veteran Owned Businesses or Veteran Owned Businesses must be registered/certified with the U.S Small Business Administration at Veteran Small Business Certification ( https://veterans.certify.sba.gov ).

The following contract clauses apply to this acquisition:

12. FAR 52.212-4, Contract Terms and Conditions Commercial Items (OCT 2018)

ADDENDUM to FAR 52.212-4 The following clauses are included as a part of the addendum:

52.204-13

System for Award Management Maintenance (OCT 2018)

52.204-18

Commercial and Government Entity Code Maintenance (AUG 2020)

52.222-19

Child Labor Cooperation with Authorities and Remedies (DEC 2022)

52.232-40

Providing Accelerated Payments to Small Business Subcontractors (DEC 2013)

VAAR clauses:

852.203-70

Commercial Advertising

852.212-71

Gray Market Items

852.219-73

VA Notice of Total Set-Aside for Certified Service-Disabled Veteran-Owned Small Business

852.232-72

Electronic Submission of Payment Requests.

852.242-71

Administrative Contracting Officer

852.246-71

Rejected Goods

852.247-71

Delivery Location

852.247-73

Packing for Domestic Shipment

4. The following subparagraphs of FAR 52.212-5 are applicable:

FAR 52.212-5 applies to this acquisition with the following FAR clauses incorporated by reference;

52.204-10

Reporting Executive Compensation & First-Tier Subcontract Awards (JUN 2020) (Pub. L. 109-282) (31 U.S.C. 6101 note)

52.209-6

Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (JUN 2020) (31 U.S.C. 6101 note)

52.219-28

52.219-27

Post Award Small Business Program Representation (MAY 2020) (15 U.S.C 632(a)(2))

Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (OCT 2022)

52.222-3

Convict Labor (JUN 2003) (E.O. 11755)

52.222-21

Prohibition of Segregated Facilities (APR 2015)

52.222-26

Equal Opportunity (SEP 2016) (E.O. 11246)

52.222-36

Equal Opportunity for Workers with Disabilities (JUN 2020) (29 U.S.C. 793)

52.222-50

Combating Trafficking in Persons (JAN 2019) (22 U.S.C. chapter 78 and E.O. 13627)

52.223-18

Encouraging Contractor Policies to Ban Text Messaging While Driving (JUN 2020) (E.O. 13513)

52.225-1

Buy American-Supplies (Oct 2022) (41 U.S.C. chapter 83)

52.225-13

Restrictions on Certain Foreign Purchases (FEB 2021)

52.232-33

Payment by Electronic Funds Transfer System for Award Management (Jul 2018) (31 U.S.C. 3332)

5. There are no additional contract requirements, terms or conditions.

6. Quotes must be emailed to Maureen.Sundstrom@va.gov and received no later than 3:00 PM PST on 07/20/2023. Quotes may be submitted on this document or the vendor s own form and must include the completed Buy American Certificate 52.225-2, and if not the manufacturer, an authorized distributor letter. Any offer that does not provide the supporting documentation will be considered non-responsive.

No late quotations will be accepted. The Government intends to make award without discussions.

7. For information regarding the solicitation, please contact Maureen Sundstrom at Maureen.Sundstrom@va.gov.

A.1 52.225-2 BUY AMERICAN CERTIFICATE (OCT 2022)

(a)(1) The Offeror certifies that each end product, except those listed in paragraph (b) of this provision, is a domestic end product and that each domestic end product listed in paragraph (c) of this provision contains a critical component.

(2) The Offeror shall list as foreign end products those end products manufactured in the United States that do not qualify as domestic end products. For those foreign end products that do not consist wholly or predominantly of iron or steel or a combination of both, the Offeror shall also indicate whether these foreign end products exceed 55 percent domestic content, except for those that are COTS items. If the percentage of the domestic content is unknown, select no .

(3) The Offeror shall separately list the line item numbers of domestic end products that contain a critical component (see FAR 25.105).

(4) The terms commercially available off-the-shelf (COTS) item, critical component, domestic end product, end product, and foreign end product are defined in the clause of this solicitation entitled Buy American Supplies.

(b) Foreign End Products:

Line item No.

Country of origin

Exceeds 55% domestic content (yes/no)

[List as necessary]

(c) Domestic end products containing a critical component:

Line item No.

[List as necessary]

(d) The Government will evaluate offers in accordance with the policies and procedures of part 25 of the Federal Acquisition Regulation.

(End of Provision)