S02 36C10X26R0027 SURGICAL TISSUE MANAGEMENT SYSTEM REQUEST FOR PROPOSAL.docx

36C10X26R0027 NX EQ SURGICAL TISSUE MANAGEMENT SYSTEM

REQUEST FOR PROPOSAL

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

36C10X26R0027

Lisa Thompson lisa.thompson10@va.gov 720-793-5907 10-9-2026 11:59pm

EST

36C10X U.S. Department of Veterans Affairs OPAL | Enterprise Procurement Office

5202 Presidents Court, Suite 103 Frederick MD 21703

X

339112 1000 Employees

N/A

36C10X U.S. Department of Veterans Affairs OPAL | Enterprise Procurement Office

5202 Presidents Court, Suite 103 Frederick MD 21703

VAFSC

U.S. Department of Veterans Affairs Financial Services Center

PO BOX 149971

(see Section B.3 invoicing/payment) Austin TX 78714-8917 1 (877) 489-6135

See CONTINUATION Page Department of Veterans Affairs (VA), Veteran Health Administration (VHA), Equipment Life Cycle Management (ELCM)

REQUEST FOR PROPOSAL

Requirements Contract: NX EQ Surgical Tissue Management System

Effective date will be 14 or more days after award date

Questions Due: 09/18/2026 at 11:59pm EST

Proposal Due: See block 8 for due date and time

See CONTINUATION Page

Jessica Smith Contracting Officer

Table of Contents

SECTION B - CONTRACT ADMINISTRATION / INVOICE INSTRUCTIONS

B.1 CONTRACT ADMINISTRATION

B.1.A. Introductory Instructions to Contractors: the Contractor shall review the solicitation and become familiar with it to ensure a thorough response is provided by the deadline as noted below. Failure to understand the contract's requirements will not relieve the contractor from performing in accordance with the strict meaning and intent thereof. Throughout this solicitation there are several “fill-ins” and “checkboxes” that must be completed and returned to the Government. In addition to filling out and submitting with its proposal, the Offeror shall provide a complete and current PDF copy of its SAMs registration, see www.sam.gov.

B.1.B. Scope of Contract: It is anticipated the award shall be made on a Brand name or equal basis conducted in accordance with (“IAW”) FAR Part 12 and 15. It is anticipated a single requirements contract will result for a 60-month ordering period consisting of a 12-month base year period and four 12-month option periods. The CLIN structure identifies all commercial supply items and any allied non-professional services available for purchase. All requirements under the subject contract will be issued under individual task/delivery orders by the respective requiring activities. There is no funding under the subject requirements contract. The financial arrangement with the contractor shall be firm-fixed price ('FFP'). This requirement shall be governed by Federal Acquisition Regulation (FAR) Part 16, 'Fixed-Price Contracts,' and any applicable Department of Veterans Affairs ('VA') VAAR clauses, policies, and regulations. If any sub-contracting opportunities exist or appear to be available, the Contractor shall specify in detail those opportunities or apparent opportunities, respectively, at the time of proposal submission.

B.1.C. Scope of Solicitation: This solicitation and resulting contract will be full and openly competed. All deadlines are identified in this solicitation. All responses shall be emailed to the Contract Specialist and Contracting Officer identified below. Late responses shall not be reviewed. The format of the solicitation and resulting contract complies with FAR 15.102.

B.1.D. Contract Administration: The Contractor shall contact the Contracting Officer on all matters pertaining to administration. Only the Contracting Officer is authorized to make commitments or issue changes that will affect the price, quantity or delivery terms of the contract. All contractual administration matters will be handled by the following individuals:

5202 Presidents Court, Suite 103 Frederick, MD 21703 Jessica.smith32@va.gov

5202 Presidents Court, Suite 103 Frederick, MD 21703 Lisa.thompson10@va.gov

Deputy Program Manager, ELCM

TBD

Contracting Officer Representative (COR), ELCM

TBD

B.2 CONTRACTOR REMITTANCE ADDRESS

All payments by the Government to the Contractor will be made in accordance with 52.232-33, Payment by Electronic Funds Transfer—System for Award Management.

B.3 INVOICES

Payment shall be submitted monthly in arrears based upon delivery, acceptance, and receipt of a properly prepared invoice 30 days of delivery.

In order to comply with the Improper Payment Elimination and Recovery Act of 2010 (IPERA), the VA has mandated electronic invoice submission to the Veterans Affairs Financial Services Center (VAFSC). The contractor shall submit invoice within 30 days of delivery.

B.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 Request.

B.5 FSC MANDATORY ELECTRONIC INVOICE SUBMISSION

Contractors are required to submit payment requests in electronic form in accordance with the submission instructions below.

TUNGSTEN ELECTRONIC INVOICE SUBMISSION

FSC e-INVOICE PROGRAM THRU AUSTIN PORTAL

FSC MANDATORY ELECTRONIC INVOICE SUBMISSION FOR AUSTIN PAYMENTS

Contracting POC: Lisa Thompson COR (Contracting Officers Representative): TBD Contract/Task Order Number: TBD

a. Contractor Electronic Invoice Submission Methods:

Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below.

1. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party Contractor, Tungsten, to transition Contractors from paper to electronic invoice submission. Please go to this website: http://www.tungsten-network.com/US/en/veterans-affairs/ to begin submitting electronic invoices, free of charge.

2. A system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) chartered by the American National Standards Institute (ANSI). The X12 EDI Web site (http://www.x12.org)

b. Contractor e-invoice Set-Up Information:

Please contact Tungsten at the phone number or email address listed below to begin submitting your electronic invoices to the VA Financial Services Center for payment processing, free of charge. If you have question about the e-invoicing program or Tungsten, please contact the FSC at the phone number or email address listed below.

1. Tungsten e-Invoice Setup Information: 1-877-489-6135

2. Tungsten e-Invoice email: VA.Registration@Tungsten-Network.com

3. FSC e-Invoice Contact Information: 1-877-353-9791

4. FSC e-invoice email: vafsccshd@va.gov See https://www.fsc.va.gov/einvoice.asp for more information.

Purchase card orders are not authorized against this contract.

B.6. REPORTS:

Monthly Report: In order for the contracting office to submit the required financial reporting on FPDS-NG the Contractor needs to submit ATTACHMENT E – REPORTING TOOL – NX EQ SURGICAL TISSUE MANAGEMENT SYSTEM on a monthly basis to the Contract Specialist and Contracting Officer Representative. The report is due by the 5th of each month.

Quarterly Report: In addition to the monthly submission, the same ATTACHMENT E – REPORTING TOOL – NX EQ SURGICAL TISSUE MANAGEMENT SYSTEM needs to be submitted quarterly as outlined below.

In order to track compliance, VA requires the Contractor to submit the quarterly report of sales in the approved format listed in ATTACHMENT E – REPORTING TOOL – NX EQ SURGICAL TISSUE MANAGEMENT SYSTEM based on the Governments fiscal calendar year. See below.

The Contractor agrees that they shall adhere to this requirement. The Contractor shall provide a quarterly report, no later than 60 calendar days after the end of each fiscal quarter ending December, March, June, and September. Reports shall be sent electronically to the SAC Government points of contact until the Contractor is notified, in writing, of a different point of contact.

a. Project Manager: TBD

b. Contracting Officer: Jessica Smith

c. Contract Specialist: Lisa Thompson

B.7 TERMS AND CONDITIONS

1. THE FOLLOWING TERMS AND CONDITIONS ARE MANDATORY

By establishing a contract, the Vendor agrees to supply established items(s) to satisfy the Government’s requirement when an order is placed under the contract during the effective period of performance. If, however, the Vendor determines to terminate production of the selected item and contemplates replacement with an alternative item, the Government reserves the right to evaluate the potential replacement item(s). There is no guarantee that the Government will evaluate any replacement item(s) favorably. If the Government determines the replacement item(s) as unacceptable, the individual item(s) or the entire contract may be canceled.

2. EXTENT OF OBLIGATION:

The Government is obligated only to the extent of authorized purchases made under the resultant contract. This contract does not obligate any funds, nor is the Government obligated to make any purchases under this contract. The Government does not guarantee any volume of purchases through a contract. The terms and conditions included in this contract apply to all purchases made pursuant to it. In the event of an inconsistency between the provisions of this contract and the contract holder’s invoice, the provisions of this contract will take precedence.

a. Uninterrupted Source of Supply - By establishing a contract, the Quoter agrees to supply established item(s) to satisfy the Government’s requirement when an order is placed under the contract during the effective period of the established contract. If the quoter decides to terminate production of the selected item and contemplates replacement with an alternative item; the Government reserves the right to evaluate the potential replacement item(s). There is no guarantee that the Government will evaluate any replacement item(s) favorably. If the Government determines the replacement item(s) is unacceptable, the individual item(s) or the entire contract may be cancelled.

b. Inspection and Acceptance - The acceptance paragraph in FAR 52.212-4 is based upon the assumption that the Government will rely on the Contractor’s assurances that the commercial item tendered for acceptance conforms to the contract requirements. The Government inspection of commercial items will not prejudice its other rights under the acceptance paragraph. The provisions of FAR 52.212-4 are incorporated by reference.

3. PURCHASE/ORDERING LIMITATIONS:

Orders placed against this contract are limited to FAR Clause 52.216-19 Order Limitations, as noted in the contract. The estimated total quantities are listed on ATTACHMENT A – PRICE COST SCHEDULE – NX EQ SURGICAL TISSUE MANAGEMENT SYSTEM. The quantities provided are estimates only, and VA makes no guarantee regarding the actual quantities that may be purchased.

The Veterans Health Administration (VHA) Equipment Life Cycle Management (ELCM) Program identified the Olympus ESG-410 Surgical Tissue Management System or Equal product line as a candidate for a VA-wide (otherwise referred to as “national”) single award Requirements contract. The Government's intent for this Requirements contract is to include all ancillary items to ensure the equipment can function as designed by the OEM and as clinically required. The Government may through bilateral modification, add or remove items to this contract that are determined to be within scope of the solicited product line, not limited to the original items awarded. Additionally, any discontinued items may be replaced via future contract modification by the replacement part identified by the OEM, so long as the replacement part serves the same clinical purpose and function as the originally awarded item. Furthermore, any new technology that is presented during the performance of this contract may be evaluated by the Government for inclusion into the contract, via bilateral modification. This new technology must be determined to be within scope of the original contract.

4. INDIVIDUALS AUTHORIZED TO PURCHASE UNDER THE CONTRACT:

This is a Enterprise Procurement Office (SAC) decentralized contract. Orders are placed by VA Government Ordering Officer (OO) in accordance with the terms and conditions of the specific contract identified in the OO appointment memorandum approved by a SAC Contracting Officer. OOs may only place orders for those contracts that are specifically appointed. Ordering Officers are responsible for issuing and administering orders placed under this contract. Ordering Officers may revise or modify their orders, but only within the scope of this contract. Ordering Officers have no authority to modify any term of this basic contract. Any deviation from the terms of the basic contract must be approved in writing by the SAC Contracting Officer responsible for this contract. Orders placed only by designated VHA ELCM Ordering Officers shall be submitted on a fully funded and completed Delivery Order. No orders shall be placed without first obtaining approved funding from a VA facility. Requesting Facility submits order requests through the NEC Order Portal ELCM NEC Ordering Portal - Power Apps for verification. Questions may be submitted to the VHAELCM OO Team via email at vaelcmnxeqorderingofficer@va.gov.

The Contractor shall accept orders against this contract only from the designated VHA ELCM OO when the Delivery Order has been reviewed by the OO for this contract. Fulfilling orders from persons other than the approved Ordering Officer may result in loss or delay in payment for supplies/services provided under such orders. When a Contracting Officer appoints an Ordering Officer in writing after award, the Contracting Officer will furnish the contractor with an updated list of individual Ordering Officers authorized to place orders against the contract. Contractor will acknowledge receipt of any order submitted by an individual Ordering Officer specified by appointment against the contract.

Ship To and Mark For: Deliveries shall be marked and shipped to various VHA locations identified in each order placed against the contract.

All shipments, either single or multiple container deliveries, shall bear and contain them on the delivery tickets or sales slips (external shipping labels and associated manifests or packing lists) the following at a minimum:

(i) Name of supplier;

(ii) Contract/Delivery Order/Task Order number;

(iii) Date of purchase;

(iv) Contract number;

(v) Itemized list of supplies or services furnished; and

(vi) Quantity, unit price, and extension of each item, less applicable discounts (unit prices and extensions need not be shown when incompatible with the use of automated systems, provided the invoice is itemized to show this information).

(vii) Date of delivery or shipment

In the case of multiple container deliveries, a statement readable near the VA Order number will indicate total number of containers for the complete shipment (ex. “Package 1 of 2”), clearly readable on manifests and external shipping labels.

The Contractor shall provide an order confirmation within four (4) working days of receipt of the delivery order.

The Contractor will provide tracking information or use of a website to obtain delivery status and proof of delivery.

The After Receipt of Order (ARO) is defined as the established number of days from Contractor’s receipt of order date to the line-item delivery date. The Contractor ARO is # days.

Packing Slips/Labels and Lists shall include the following:

IFCAP PO # ____________ (i.e., 166-E11234) Total number of Containers: Package ___ of ___. (i.e., Package 1 of 3)

B.8 ACKNOWLEDGMENT OF AMENDMENTS

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

B.9 PRICE/COST SCHEDULE

This is a nationwide Department of Veterans Affairs Requirements Contract for the procurement of the Olympus ESG-410 Surgical Tissue Management System or Equal, to include accessories, consumables, installation, training, proctoring services, annual warranty and maintenance services, in accordance with ATTACHMENT B – CONTRACT ADMINISTRATION - NX EQ SURGICAL TISSUE MANAGEMENT SYSTEM. The quantity delivered will be dependent on the numbers ordered by the VA Medical Centers.

ATTACHMENT A - PRICE COST SCHEDULE - NX EQ SURGICAL TISSUE MANAGEMENT SYSTEM shall be updated, as applicable, to capture all current items for sale, their respective price, as well as the imbedded 3% SLA fee, and shipping. Currently, the shipping fee for Instruments and Accessories is capped at $25.00 per item through any qualified third-party carrier. Any pricing which is rounded down in the VA’s favor shall be identified. The standard Government CLIN structure lists items sequentially, and each option period is generally designated with the first digit as corresponding to that option period. The Contractor will provide literature for each CLIN listed in Attachment A with Technical Specifications, Product Brochure, and Color Swatch (if applicable) at no additional cost prior to the contract effective date.

INSTALLATION

At no additional cost, and as configured at the time of acquisition, Customer will be entitled to the installation and setup of the Surgical Tissue Management System and all associated accessories and software for the system’s intended purpose(s) by manufacturer trained/authorized personnel. Installation and setup shall include the assembly/installation of all hardware components configured per end user preferences, customized setup of applicable Patient Monitoring Systems, training and education for Clinical staff on the operational use and end user maintenance of the overall system, technical training and education for Biomedical Engineers on the operational use and any intermediate/advanced maintenance of the overall system, as well as data integration setup (to include when/if VA Facilities have met all VA Directive and Handbook 6500 Information Security requirements/approvals for the heart-lung bypass unit(s) to securely transmit and receive data across the VA network).

SOFTWARE INSTALLATION AND UPDATES

The Contractor grants to VA non-exclusive, non-transferrable licenses to use the Surgical Tissue Management System and all associated accessories and software, including any documentation, for the system’s intended purposes. At no additional cost, Customer will be entitled to Software updates when such updates are made generally available without cost to other licensees of the software. The Contractor shall coordinate the installation of any software upgrades with designated facility POC and Biomedical Engineer.

MAINTENANCE, REPAIRS AND REPLACEMENT

Preventative Maintenance will be performed as prescribed by the manufacturer’s specifications. Maintenance, repairs, and replacement will be performed by authorized technicians and will be coordinated through the designated facility POC and Biomedical Engineer. At the time of installation, and/or for any reoccurring onsite visit(s) to perform preventative maintenance, repairs, replacement, etc., the Contractor must comply with all local policies to gain access to individual VA Medical Centers.

PRODUCT REFRESH

Product refresh is when a current CLIN is no longer being manufactured due to obsolescence and the product item is being replaced with a newer, and more often, a superior version of the same item. The current CLIN product will be revised to reflect the refreshed product information, manufacturer’s part number, IDIQ price (inclusive of Service Level Agreement (SLA) fee), etc.

The Government reserves the right to not accept the products offered under product refresh. The contractor will be notified in writing if a product refresh is not accepted. All products offered shall be provided with the warranty that is agreed upon for this contract. The contractor agrees to ensure that all upgraded improved/replaced products meet American with Disabilities Act (ADA) and Health Information Portability and Accountability Act (HIPAA) Federal requirements, see attachment 5.

The contractor shall provide the COR and CO the following information for product refresh:

(1) A list of specific awarded item(s) being refreshed in the Price/Cost Schedule (to include commercial pricing, discount offered, and IDIQ price (inclusive of SLA fee));

(2) Product literature for the item(s) refreshed;

(3) A detailed description of the differences or benefits of refreshed as compared to the item(s) being discontinued or added;

(4) Proper identification of any product requirements and/or procedures related to those product(s) proposed to be refreshed or upgraded;

(5) FDA approval, if applicable;

(6) Provide historical sales to VA by item(s), if applicable; and

(7) Copy of Commercial Warranty

The request shall be submitted to the COR, copy to the Contract Specialist and Contract Officer, for review and recommendation of approval to be submitted to the CO. The CO shall prepare a bilateral modification for execution.

PRODUCT REMOVAL OR RECALL

For any product awarded under this contract removed or recalled by the manufacturer due to defects in the product or potential dangers to patients, or if any required removal or recall is suggested or mandated by a regulatory or official agency, the manufacturer shall resolve any defects or potential dangers by repairing or replacing the product at no cost to the government. The manufacturer agrees to take following steps immediately:

Notify the Contracting Officer (CO) at the Enterprise Procurement Office in writing, by the most expeditious manner possible.

Provide copies of the notification to CO, Contracting Specialist, Contracting Officer Representative, and Manager at Product Recall Office, all Agencies and VA Facilities who purchased the product, which include, but not be limited to the following:

(1) Complete item description and/or identification, order numbers from customers and the contract number assigned as a result of an issuance on the solicitation;

(2) Reasons for modifications, removal or recall; and

(3) Necessary instructions for return for credit, replacement or corrective action.

A copy of the notification will be provided to:

Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106

B.10 TRAINING

The ordering facility and the Contractor/manufacturer will schedule any offered/quoted training as established by CLIN. Training mode of delivery and training schedule will be purchased based on facility needs.

B.11 MAINTENANCE, REPAIRS, AND REPLACEMENTS

Instructions and procedures will be provided by the Contractor specific to the warranty, maintenance, repairs, and replacement of product and services. At minimum, the Contractor will provide the manufacturer warranty period that may include response time, parts, associated maintenance services, products, and consumables.

1. SCOPE OF WORK:

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Surgical Tissue Management System product line as a candidate for a VA-wide (otherwise referred to as "national") Requirements contract.

The Surgical Tissue Management System is an advanced, energy-based surgical platform used across Veterans Affairs Medical Centers (VAMCs) in operating rooms, procedural suites, and endoscopy units to perform precise tissue coagulation, devitalization, cutting, and vessel sealing. The system delivers radiofrequency (RF) energy and ultrasonic energy through specialized electrodes and hand instruments to support uniform, noncontact coagulation with minimal tissue penetration, improved visualization, and reduced bleeding. The unit provides both radiofrequency power to drive electrosurgical instruments and mechanical vibrations to power ultrasonic surgical instruments used to join or seal blood vessels. The unit typically features receptacle ports, various output settings, power levels, and control mechanisms to adjust the energy delivered to the surgical site. It may also have features such as audible alarms, power monitoring, and temperature regulation.

This universal platform provides multiple energy modalities (ultrasonic, bipolar, and RF) to support a broad range of open, laparoscopic, and endoscopic procedures in general surgery, urology, and gynecology, helping reduce the number of separate generators and instruments required in the operating room. It is designed to enhance surgical efficiency, improve hemostasis, and support consistent, replicable outcomes across diverse clinical applications.

The primary hand instrument is a hybrid ultrasonic and bipolar electrosurgical device intended for use in open and laparoscopic procedures to cut, seal, coagulate, and dissect with two distinct modes of action: Seal & Cut and Seal Only. It is indicated for ligation and division of vessels (up to and including 7 mm), lymphatics, and tissue bundles, and may be used in minimally invasive or open surgical procedures where vessel sealing and tissue division are desired. The device is intended for single use only and has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Surgical Tissue Management Systems to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for a base period of 12 months with four 12-month option periods.

2. REQUIREMENT

This requirement will be solicited and awarded as a "Brand Name or Equal" acquisition, which requires the quoter to indicate that each product being offered as an "equal" product is equal to the Olympus ESG-410 Surgical Tissue Management System. For each equal product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The quoter must also clearly identify the item by brand name (if any) and make/model number. Finally, the quoter must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements.

The Department of Veterans Affairs (VA) is seeking vendors who can provide Olympus ESG-410 Surgical Tissue Management System or equal as listed above which meet all the salient characteristics listed below. Vendors may quote any product solution or configuration so long as they meet the salient characteristics. Products quoted in the technical volume must be captured on the Vendor’s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may quote any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor’s pricing volume with a quantity of zero. Vendors are required to complete the highlighted area on the SCs Chart located below listing the location where compliance to the SCs can be found. The chart must be included with the vendor’s submission. Offers which do not include this complete chart will not be considered for award.

CLIN’s 0001-0005 apply to the following SC’s

the U.S. Food and Drug Administration (FDA) Literature Review

· The neutral electrode is detaching from the patient.

· The neutral electrode is disconnected.

· Short circuit of the neutral electrode.

Literature Review

Literature Review

· monopolar cut > 300W

· monopolar coag >200W

· bipolar cut > 100W (320 saline)

· bipolar coag > 120W (200 saline) Literature Review

Additionally, proposals shall include sufficient product details to allow for meaningful evaluation of the technical subfactors listed below.

Technical Subfactors Design Design features and functions of the offered device will be evaluated for their ability to aid in the performance of its intended function. Areas include but are not limited to the following:

1. Ability to integrate with other surgical equipment

2. Probe functions/versatility

3. Customization for various procedures (options)

4. Irrigation options/availability

5. Number and variety of input/output connections/ports for peripheral devices

6. Types of procedures supported

Performance The device will be evaluated for its ability to perform its intended function. Areas include but are not limited to:

1. Touch screen features and ease of use

2. Workflow performance of complete system

3. Types/modes of energy (above and beyond what is in the SCs)

4. Power adjustability

Safety The device will be assessed for patient safety features, including, but not limited to, the following areas:

1. Audible tones and visual alarms

2. Contact monitoring data display

Quality/Service/Training

1. Training – Availability and options

2. Service – Terms and conditions

3. Warranty – Terms and conditions

SECTION C - CONTRACT CLAUSES

C.1 MANDATORY WRITTEN DISCLOSURES

Mandatory written disclosures required by FAR clause 52.203-13 to the Department of Veterans Affairs, Office of Inspector General (OIG) must be made electronically through the VA OIG Hotline at https://www.va.gov/oig/hotline/ and clicking on "FAR clause 52.203-13 Reporting." If you experience difficulty accessing the website, call the Hotline at 1-800-488-8244 for further instructions.

(End of Clause)

C.2 EPO 18-01 EPO SERVICE LEVEL AGREEMENT FEE AND SUBMISSION OF QUARTERLY SALES REPORTS: OPEN MARKET (JAN 2016)

a. Service Level Agreement Fee.

The Service Level Agreement (SLA) fee is established by the Supply Fund Board and is provided as a means of reimbursement for customary acquisition-related services necessary to obtain contractor services and/or supplies as required. The SLA is reimbursed to the EPO based on rates established by the supply fund board and are recouped based on a percentage of total quarterly sales. The Supply Fund Board may change the percentage at any time, but typically not more than once per year. Upon a change in the SLA, the Contracting Officer (CO) shall issue a unilateral modification to apply the change to CLIN prices based upon the SLA rate change. The EPO will provide reasonable notice prior to the effective date of the change.

In order to facilitate SLA reimbursement, offerors must include (imbed) the SLA fee into their prices; therefore, the fee will be reflected in the total amount charged and transparent to ordering activities.

The current SLA which applies to this contract action is 3.0%. This SLA Fee shall be imbedded in the awarded contract/agreement price(s) and offers submitted in response to this solicitation shall include this SLA Fee in the price of every line item offered.

b. Quarterly Sales Reports.

The Contractor shall report all contract sales under this contract and submit collected SLAs as follows:

Government under the terms of Federal Acquisition Regulation (FAR) Subpart 32.6. The Government may exercise all rights under the Debt Collection Improvement Act of 1996, including withholding or setting off payments and interest on the debt (see FAR clause 52.232-17, Interest). Should the Contractor fail to submit the required sales reports, falsify them, or fail to timely pay the SLA, the Government shall have, in addition to the rights and remedies described in this clause, all other rights and remedies permitted by Federal law and statutes.

(1) The Contractor shall accurately report the dollar value, in U.S. dollars and rounded to the nearest whole dollar, of all sales made under this contract by calendar quarter (January 1–March 31, April 1–June 30, July 1–September 30, and October 1–December 31). Reported sales must include all sales made to all authorized contract or agreement users, whether shipped directly to the users or through Prime Vendor contractors. The report shall reflect sales by contract line-item and shall segment sales by the Department of Veterans Affairs (VA) and Other Government Agencies (OGA). The reported contract sales shall include the SLA Fee and each quarterly report shall show the total SLA Fee amount collected on the reported sales. The Contractor shall maintain a consistent accounting method of sales reporting, based on the Contractor’s established commercial accounting practice. The Contractor shall consistently use only one of the following acceptable points at which sales may be reported—

(2) Sales under this contract/agreement shall be reported to the EPO within 60 calendar days following the completion of each reporting quarter. The Contractor shall continue to furnish quarterly reports, including “zero” sales, through physical completion of the last outstanding order of the contract/agreement.

(3) The sales report signed by an authorized representative of the contractor shall be emailed to the appropriate individual(s) listed in the terms and conditions of the contract or agreement.

c. SLA Remittance

The Contractor shall remit the SLA fee to the SAC in U.S. dollars within 60 calendar days after the end of the reporting quarter and final payment shall be remitted within 60 days after physical completion of the last outstanding task order or delivery order of the contract.

The SLA Fee amount collected and due shall be paid electronically. To ensure that the payment is credited properly, the contractor shall electronically transmit the SLA fee along with the coinciding quarterly sales report at www.pay.gov (VA Enterprise Procurement Office (EPO)); specific instructions shall be provided when the contract action resulting from this solicitation is awarded (i.e. post-award/BPA issuance conference and/or post-award letter when used in lieu of a conference).SA

The Government reserves the right to inspect, without further notice, such records of the Contractor as pertinent to sales under any contract or agreements resulting from this solicitation. Failure to remit the full amount of the SLA within 60 calendar days after the end of the applicable reporting period constitutes a contract debt to the United States Government under the terms of Federal Acquisition Regulation (FAR) Subpart 32.6. The Government may exercise all rights under the Debt Collection Improvement Act of 1996, including withholding or setting off payments and interest on the debt (see FAR clause 52.232-17, Interest). Should the Contractor fail to submit the required sales reports, falsify them, or fail to timely pay the SLA, the Government shall have, in addition to the rights and remedies described in this clause, all other rights and remedies permitted by Federal law and statutes.

(End of Clause)

C.3 52.211-11 LIQUIDATED DAMAGES-SUPPLIES, SERVICES, OR RESEARCH AND DEVELOPMENT (SEP 2000)

(a) If the Contractor fails to deliver the supplies or perform the services within the time specified in this contract, the Contractor shall, in place of actual damages, pay to the Government liquidated damages of $37.50 per calendar day of delay.

(b) If the Government terminates this contract in whole or in part under the Default-Fixed-Price Supply and Service clause, the Contractor is liable for liquidated damages accruing until the Government reasonably obtains delivery or performance of similar supplies or services. These liquidated damages are in addition to excess costs of repurchase under the Termination clause.

(c) The Contractor will not be charged with liquidated damages when the delay in delivery or performance is beyond the control and without the fault or negligence of the Contractor as defined in the Default-Fixed-Price Supply and Service clause in this contract.

(End of clause)

C.4 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (OCT 2025)

(a) Inspection/Acceptance. The Contractor shall only tender for acceptance those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or reperformance of nonconforming services at no increase in contract price.