36C25625Q0904_1.docx

Attachment 1: Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

GENERAL INFORMATION

(SLVHCS)

2400 Canal Street

New Orleans LA

CONTACT INFORMATION

Network Contracting Office 16 5075 Westheimer Road, Suite 750

Houston TX 77056-5643

POINT OF CONTACT*

Contract Specialist Christopher Rossi christopher.rossi2@va.gov 281-435-1681

ADDITIONAL INFORMATION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

This is an INTENT TO SOLE SOURCE NOTICE only.

The Department of Veteran Affairs, Network Contracting Office (NCO) 16, intends to issue a sole-source contract under the authority of 41 U.S.C 253(c) (1) - FAR 6.302-1 (only one responsible source and no other supplies or services will satisfy agency requirements), to Lowell Government Services Inc located at 223 W Gregory St, Pensacola, FL 32502 USA. Supplies will be delivered from 05/23/2025 through 05/22/2026 under NAICS 339112. The Vendor shall provide FlowTriever Retrieval/Aspiration System support located at the Southeastern Louisiana Veterans Health Care System (SLVHCS), 2400 Canal St, New Orleans, LA 70119. This action will result in a firm-fixed-price service contract. Clause 52.217-9, Option to Extend the Term of the Contract, applies.

This notice of intent is not a request for quotations; interested parties may express their interest by providing a capabilities statement not later than 05/15/2024 at 13:00 PM CST, to christopher.rossi2@va.gov . When responding to this announcement, respondents should refer to number 36C25625Q0904, Notice of Intent in the subject line. The capabilities statement must provide clear and unambiguous evidence to substantiate the capability of the party to provide the required services. Responding as an interested party under the www.sam.gov website does not constitute convincing evidence of capabilities. A determination not to compete this proposed contract upon responses to this notice is solely within the discretion of the Government. Verbal and facsimile responses are not acceptable and will not be considered. All interested parties are reminded to be registered with System for Award Management (SAM) at https://sam.gov/SAM/ in order to be eligible for award of Government contracts. No telephone calls will be accepted. If after May 15th, 2025, no viable responses have been received in response to this announcement, NCO 16 shall negotiate solely with Lovell Government Services Inc. Furthermore, the government reserves the right to make a sole-source award regardless of the responses received to this notice, if determined to be in the best interest of the government.

The Government anticipates the award of a firm-fixed-price contract. A determination by the Government whether to compete the proposed requirement shall be based upon responses received and is solely within the discretion of the government. Information received shall be considered solely for the purpose of determining whether to conduct a competition.

REQUIRED SERVICES:

The purpose of this service contract is for the consignment of five (5) Inari FlowTriever Retrieval/Aspiration Systems at Southeast Louisiana Veterans Health Care System (SLVHCS), 2400 Canal St, New Orleans, LA 70119.

Presolicitation Notice Presolicitation Notice This is a notice of intent to sole source Inari FlowTriever Retrieval/Aspiration System in order to perform a life saving procedure on patients who may present to the emergency room with a pulmonary emboli. The Interventional Radiology Section of Diagnostic Imaging Service will perform emergency PE Studies when needed to save the patient’s life.

Presolicitation Notice

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE

DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a.

PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE

ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26.

TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C25625Q0904 05-08-2025 Christopher Rossi christopher.rossi2@va.gov 05-15-2025 13:00

CDT

Department of Veterans Affairs Network Contracting Office 16 1515 Poydras Street Suite 1100 New Orleans LA 70112 X 339113 $34 Million N/A Department of Veterans Affairs Southeast Louisiana Veterans Health Care System (SLVHCS) 2400 Canal Street New Orleans LA 70119 Department of Veterans Affairs Network Contracting Office 16 1515 Poydras Street Suite 1100 New Orleans LA 70112

FSC e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp Invoice Setup Information 1-877-489-6135 Invoice must be submitted electronically

See CONTINUATION Page The Southeast Louisiana Veterans Health Care System has a need to purchase five (5) Inari FlowTriever Retrieival Aspiration systems.

See CONTINUATION Page x X Contract Officer Page 1 of Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C256 Department of Veterans Affairs Network Contracting Office 16 1515 Poydras Street Suite 1100

New Orleans LA 70112

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

FT-PPP Inari FlowTriever Retrieval/Aspiration System - Price Per Procedure (price per procedure includes one or more Aspiraiton Guide Catheters and any Flow Triever Catheters needed for procedure) Contract Period: Base POP Begin: 05-23-2025 POP End: 05-22-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing PRODUCT/SERVICE CODE: 6515 - Medical and Surgical Instruments, Equipment, and Supplies

LOCAL STOCK NUMBER: FT-PPP

22-101 Inari Aspiration Guide Catheter - Triever24 (24 Fr, 90 cm)

POP Begin: 05-23-2025 POP End: 05-22-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing

LOCAL STOCK NUMBER: 22-101

21-201 Inari Aspiration Guide Catheter - Triever20 Curve - 20 Fr, 105 cm.

POP Begin: 05-23-2025 POP End: 05-22-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing

LOCAL STOCK NUMBER: 21-201

80-101 Inari FlowSaver Blood Return System

POP Begin: 05-23-2025 POP End: 05-22-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing

LOCAL STOCK NUMBER: 80-101

52-101 Inari Intri24 Introducer Sheath, 24Fr, 33 cm

POP Begin: 05-23-2025 POP End: 05-22-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing

LOCAL STOCK NUMBER: 52-101

70-103 Inari FlowStasis Suture Retention Device (1 EACH)

POP Begin: 05-23-2025 POP End: 05-22-2026 PRINCIPAL NAICS CODE: 339113 - Surgical Appliance and Supplies Manufacturing

LOCAL STOCK NUMBER: 70-103

36C25625Q0904

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SECTION C - CONTRACT CLAUSES

C.1 FSS RFQ INTRODUCTORY LANGUAGE

The terms and conditions of the contractor's FSS contract (including any contract modifications) apply to all Blanket Purchase Agreements (BPA) and task or delivery orders issued under the contract as a result of this RFQ. When a lower price has been established, or when the delivery terms, FOB terms, or ordering requirements have been modified by the BPA or task/delivery order, those modified terms will apply to all purchases made pursuant to it and take precedence over the FSS contract. Any unique terms and conditions of a BPA or order issued under the contract that are not a part of the applicable FSS contract will govern. In the event of an inconsistency between the terms and conditions of a BPA or task/delivery order and the Contractor's FSS terms, other than those identified above, the terms of the FSS contract will take precedence.

C.2 VAAR 852.208-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS – ORDERS or BPAs (JAN 2023) (DEVIATION)

(a) In an effort to increase contracting opportunities for Veterans, depending on the evaluation factors included in the solicitation, VA will evaluate responses received based on the schedule Contractor’s certified service-disabled veteran-owned small business/veteran-owned small business (SDVOSB/VOSB) status; and/or their proposed use of certified SDVOSB/VOSB listed in the SBA certification database on the SBA Veteran Small Business Certification Program portal at https://veterans.certify.sba.gov/ (see 13 CFR 128) as subcontractors or teaming partners.

(b) To receive credit under this clause a contractor or subcontractor must be listed, at time of submission of offer/quotes and at time of award, as certified SDVOSB/VOSB in the SBA certification database on the SBA Veteran Small Business Certification Program portal at https://veterans.certify.sba.gov/ (see 13 CFR 128) and be otherwise eligible in accordance with SBA size Standards for the acquisition and limitations on subcontracting requirements set forth in SBA regulations (see 13 CFR 121, 125 and 128.).

(c) A certified SDVOSB listed in the SBA certification database schedule holder will receive full credit, and a certified VOSB listed in the SBA certification database schedule holder will receive partial credit for the SDVOSB/VOSB status evaluation factor.

(d) Offerors other than SDVOSBs or VOSBs proposing to use certified SDVOSBs/VOSBs listed in the SBA certification database as subcontractors/teaming partners, will receive some consideration under this evaluation factor. To receive consideration, offerors must provide in their proposals:

(1) The name(s) and contact information of the certified SDVOSB(s)/VOSB(s) listed in the SBA certification database with whom they intend to team or subcontract.

(2) A brief description of the proposed team or subcontractor(s) arrangement.

(3) The approximate dollar value of the proposed teaming arrangements or subcontract(s).

(4) Evidence of teaming partner/ subcontractor’s listing in the SBA certification database.

(e) Pursuant to 38 U.S.C. 8127(g), any business concern that is determined by VA to have willfully and intentionally misrepresented a company’s SDVOSB/VOSB status is subject to debarment for a period of not less than five years. This includes the debarment of all principals in the business.

(End of Clause)

C.3 VAAR 852.208-71 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTOR COMMITMENTS-ORDERS AND BPAS (JAN 2023) (DEVIATION)

(a) The Contractor agrees, if selected on the basis of having certified service-disabled veteran-owned small business (SDVOSB) or veteran-owned small business (VOSB) status (see 13 CFR 128), to comply with the eligibility requirements in subpart 819.70, including the limitation on subcontracting requirements at 13 CFR 125.6.

(b) The Contractor agrees, if selected for award on the basis of teaming/subcontracting in accordance with 852.208–70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors—Orders and BPAs, to use the evaluated firm(s) as proposed or if approved by contracting officer to substitute one or more certified SDVOSB/VOSB listed in the SBA certification database for work of the same or similar value.

(c) Pursuant to 38 U.S.C. 8127(g), any business concern that is determined by VA to have willfully and intentionally misrepresented a company’s SDVOSB/VOSB status is subject to debarment for a period of not less than five years. This includes the debarment of all principals in the business.

(End of Clause)

C.4 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract. Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause)

C.5 VAAR 852.247-71 DELIVERY LOCATION (OCT 2018)

Shipment of deliverable items, other than reports, shall be to:

Department of Veterans Affairs Southeast Louisiana Veterans Health Care System (SLVHCS) 2400 Canal Street New Orleans LA 70119 (End of Clause)

C.6 VAAR 852.247-72 MARKING DELIVERABLES (OCT 2018)

(a) The contract number shall be placed on or adjacent to all exterior mailing or shipping labels of deliverable items called for by the contract.

(b) Mark deliverables, except reports, for:

(End of Clause)

C.7 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

Material shall be packed for shipment in such a manner that will insure acceptance by common carriers and safe delivery at destination. Containers and closures shall comply with regulations of carriers as applicable to the mode of transportation.

(End of Clause)

C.8 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Clause)

C.9 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office. Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

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SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

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SECTION E - SOLICITATION PROVISIONS

E.1 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021) The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it ‘‘does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument’’ in paragraph (c)(1) in the provision at 52.204–26, Covered Telecommunications Equipment or Services—Representation, or in paragraph (v)(2)(i) of the provision at 52.212–3, Offeror Representations and Certifications–Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it ‘‘does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services’’ in paragraph (c)(2) of the provision at 52.204–26, or in paragraph (v)(2)(ii) of the provision at 52.212–3.

(a) Definitions. As used in this provision— Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition. (1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115–232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115–232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for “covered telecommunications equipment or services.”

(d) Representations. The Offeror represents that—

(1) It [ ] will, [ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds “will’’ in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that— It [ ] does, [ ] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services. The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds “does’’ in paragraph (d)(2) of this section.

(e) Disclosures. (1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded “will’’ in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded “does’’ in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of Provision)

E.2 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation provisions by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. The offeror is cautioned that the listed provisions may include blocks that must be completed by the offeror and submitted with its quotation or offer. In lieu of submitting the full text of those provisions, the offeror may identify the provision by paragraph identifier and provide the appropriate information with its quotation or offer. Also, the full text of a solicitation provision may be accessed electronically at this/these address(es):

https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/

(End of Provision)

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DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C256-25-AP-2771

1. Contracting Activity: Department of Veterans Affairs, VISN 16, Southeast Louisiana Veterans Healthcare System (SLVHCS), 2400 Canal Street, New Orleans, LA 70119.

629-24-2-087-0261

2. Description of Action: The Southeast Louisiana Veterans Health Care System has a need to purchase a supply called the Inari FlowTriever Retrieval/Aspiration System in order to perform a life saving procedure on patients who may present to the emergency room with a pulmonary emboli. The Interventional Radiology Section of Diagnostic Imaging Service will perform emergency PE Studies when needed to save the patient’s life.

Order against: |X| FSS Contract Number: V797D-50450

3. Description of Supplies or Services:

The estimated value of the proposed action is $

The FlowTriever is the first mechanical thrombectomy device FDA-indicated and purpose-built for the treatment of pulmonary embolism, removing large clots from big vessels such as the pulmonary arteries without the need for thrombolytic drugs and consequent ICU stay. A pulmonary embolism is caused when blood clots break free in the deep veins of the body and travel through the venous system to become lodged in the pulmonary arteries. The blockage of blood flow results in right heart strain as the right ventricle is unable to push blood past the clot. In severe cases, right heart failure may occur leading to a fatal event.

4. Authority:

Order Against FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception:

|_| An urgent and compelling need exists, and following the procedures would result in unacceptable delays(FAR 8.405-6(a)(1)(i)(A);

|X| Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; (FAR 8.405-6(a)(1)(i)(B));

|_| In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order and the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order was not previously issued under sole-source or limited-sources procedures (FAR 8.405-6(a)(1)(i)(C)); or

|_| Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer (FAR 8.405-6(b)).

5. Rationale/explanation to support cited authority: The Inari FlowTriever Retrieval system is approved by the FDA for the purpose of treating pulmonary emboli (PE) by removing large clots from the large vessels such as the pulmonary arteries. The PE is caused by blood clots breaking away form the veins of the body and traveling through the venous system and become lodged in the pulmonary arteries. The clots block blood from flowing to the heart properly, in some cases, the heart will fail because blood is not reaching the heart and will lead to heart failure. The only similar product is Boston Scientific’s EKOS Endovascular System which uses a similar technique to retrieve blood clots. However, the Inari FlowTriever System allows proceduralists to perform a percutaneous, mechanical thrombectomy of the clot without thrombolytics. Lovell Government Services is the sole authorized distributor for this product in Texas.

6. BRAND NAME ONLY: This buy is estimated to exceed $25,000 and this documentation will be posted along with the RFQ on e-Buy, as required by FAR 8.405-1(e).

7. Note that this determination satisfies the requirements of FAR 8.405-6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.

Statement of Work Inari FlowTriever Retrieval/Aspiration System Southeast Louisiana Veterans Health Care System New Orleans, LA

Part I: General Information

A. Introduction

The overall purpose is to provide a lifesaving instrument in the form of a mechanical thrombectomy device to Southeast Louisiana Veterans Health Care System (SLVHCS) in the Interventional Radiology Section, Room 2F200, 2400 Canal Street, New Orleans, LA 70119.

The device is called the Inari FlowTriever Retrieval/Aspiration System B. Background This particular device will be used to perform high risk procedures to remove pulmonary emboli from patients at risk of death if large clots are not removed from large arteries. We have had several successful procedures performed by the Interventional Radiology Section of Diagnostic Imaging Service.

C. Scope The contractor shall provide the FlowTriever as ordered by Interventional Radiology, a section of Diagnostic Imaging Service at SLVHCS, New Orleans, LA. The order will be placed for an Inari FlowTriever Retrieval/Aspiration System, Item #FTPPP, consisting of the following items: Item #22-101, Inari Aspiration Guide Catheter-Triever 24 (24 Fr, 90 cm), Item #21-201, Inari Aspiration Guide Catheter – Triever 20 Curve – 20 Fr, 105 cm, Item # 52-101, Inari Intri24 Introducer Sheath, 24 Fr, 33 cm, Item #80-101, Inari FlowSaver Blood Return System, and Item #70-103, Inari Flow Stasis Suture Retention Device. Contractor shall replenish products to the shelf as they are used per procedure up to the contractual number of five (5) systems.

D. Applicable documents 10 Code of Federal Regulations, Part 35 Part II: Requirements E. Delivery: The vendor shall deliver the device to the Interventional Radiology Section of Diagnostic Imaging Service.

G. Additional Requirements This is a request for five (5) Inari Systems

CHANGES TO STATEMENT OF WORK

Any changes to this Statement of work (SOW) shall be authorized and approved only through written correspondence from the Contracting Officer. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the Contracting Officer shall be borne by the contractor.

SPECIAL REQUIREMENTS: None

CONFIDENTIALITY AND NONDISCLOSURE

The preliminary and final deliverables and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order are the exclusive property of the U.S. Government and shall be submitted to the Contracting Officer after the task order.

No information shall be released by the contractor. Any request for information relating to this task order presented to the contractor shall be submitted to the Contracting Officer for response.

Press releases, marketing material or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the Contracting Officer.

INVOICES AND PAYMENT:

Invoices shall be submitted through VA’s Electronic Invoice Presentment and Payment System (IPPS). (See Web site at http://www.fsc.va.gov/einvoice.asp.)

The Contractor shall contact the COR if they do not receive payment within 45 calendar days of submission of a proper invoice.

CONTRACT ADMINISTRATION:

The Contractor shall contact the Contracting Officer on all matters pertaining to the administration of the contract. Only the Contracting Officer is authorized to make commitments or issue changes which will affect price, quantity, quality, services, or delivery of this contract.

VHAPG Part 808.405-6 Limiting Sources Page 25 of 25 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: 36C256-25-AP-2771