36C10X26Q0059.docx

Combined Synopsis/Solicitation Notice

GENERAL INFORMATION

SET-ASIDE

Department of Veterans Affairs

5202 Presidents Court, Suite 103 Frederick MD 21703

POINT OF CONTACT*

Contract Specialist Daleta Coles Daleta.Coles@va.gov Contracting Officer Hosea Berkley Hosea.Berkley@va.gov

PLACE OF PERFORMANCE

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

DESCRIPTION

Combined Synopsis/Solicitation Notice

Solicitation Number:

36C10X26Q0059

Notice Type:

Combined Synopsis/Solicitation

Synopsis:

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with (IAW) the format in Federal Acquisition Regulation (FAR) 12.202, “Publicizing,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation will not be issued.

Solicitation number 36C10X26Q0059 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Quote (RFQ). This combined synopsis/solicitation is issued under the agency's implementation of the Federal Acquisition Regulation (FAR) Overhaul, as adopted through agency class deviation. All applicable provisions, clauses, definitions, and procedures are those contained in the Overhaul text and the agency's implementation deviations. In the event of a conflict with the codified FAR, the adopted Overhaul text governs. The full text of provisions and clauses may be accessed electronically at https://www.acquisition.gov/far-overhaul/far-part-deviation-guide.

Requirement Description:

The Veterans Health Administration (VHA) Non-Expendable (NX) National Program has identified the Erbe® VIO 3, Electrosurgical Units, Argon-Enhanced Coagulation product line as a candidate for an Enterprise-wide (otherwise referred to as “national”) single Requirements contract award. Electrosurgical Units (ESUs); Argon-Enhanced Coagulation (AEC) are advanced, energy based surgical systems used to perform precise tissue coagulation and devitalization across Veterans Affairs Medical Centers (VAMCs), particularly in operating rooms (OR), procedural suites, and endoscopy units. They deliver radiofrequency (RF) energy through specialized electrodes while directing a controlled flow of inert argon gas to create a conductive plasma at the tissue surface. This results in uniform, noncontact coagulation with minimal tissue penetration, improved visualization, and reduced bleeding. ESUs with AEC are designed to enhance surgical efficiency, improve hemostasis, and support consistent, replicable outcomes across a range of open, laparoscopic, and endoscopic procedures.

These systems provide real-time, automated control of power delivery, argon flow, and activation mode, with integrated safety monitoring and configurable presets for procedure-specific use. They are optimized to increase clinical efficiency and reduce complications through precision energy delivery, reliable tissue effect profiles, and comprehensive safety interlocks.

A single award Requirements contract will be awarded IAW all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Quotes shall contain the terms for cost/price and technical capabilities of brand name equipment. The Government reserves the right to award without discussions.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339112 – Surgical and Medical Instrument Manufacturing, Product Service Code: 6515 – Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 1,000 employees. This procurement action is issued as Full and Open.

This acquisition is for a single award Requirements contract with firm-fixed priced (FFP) delivery orders IAW FAR Part 16.5 for “Brand Name or Equal” which requires the offeror indicate that each product being offered as an “equal” product to the Brand Name Olympus ESG-300 Electrosurgical System.

Offerors shall provide a quote for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A - PRICE COST SCHEDULE - NX EQ Electrosurgical Units, Argon-Enhanced Coagulation.

The ordering period is for one 12-month base year with four 12-month option years. Delivery is Free on Board (FOB) destination. FFP Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities.

The FAR provision at 52.212-1, Instructions to Offerors-Commercial Products And Commercial Services, applies to this acquisition including attached addenda to the provision (see ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ Electrosurgical Units, Argon-Enhanced Coagulation).

The FAR provision at 52.212-2, Evaluation-Commercial Products and Commercial Services, and the specific evaluation criteria as attached addenda also applies to this acquisition (see ATTACHMENT D - NX EQ Electrosurgical Units, Argon-Enhanced Coagulation).

Clause at 52.212-4, Contract Terms and Conditions-Commercial Products and Commercial Services, applies to this acquisition and a statement regarding any addenda to the clause. (see ATTACHMENT C - CONTRACT CLAUSES – NX EQ Electrosurgical Units, Argon-Enhanced Coagulation).

All interested Offerors must be registered in the System for Award Management (SAM) prior to submitting a quote. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 11:59 PM EST on April 09, 2026, to Contract Specialist (CS) Daleta Coles, Daleta.Coles@va.gov and Contracting Officer (CO) Hosea Berkley, Hosea.Berkley@va.gov. No questions will be accepted after the due date. No calls will be accepted.

Quotes are due via email by 11:59PM EST on April 15, 2026, to Contract Specialist (CS) Daleta Coles, Daleta.Coles@va.gov and Contracting Officer (CO) Hosea Berkley, Hosea.Berkley@va.gov

PRODUCT DESCRIPTION

1. SCOPE OF WORK

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified Electrosurgical Units (ESUs); Argon-Enhanced Coagulation product line as a candidate for a VA-wide (otherwise referred to as “national”) single Requirements contract award.

Electrosurgical Units (ESUs); Argon-Enhanced Coagulation (AEC) are advanced, energy based surgical systems used to perform precise tissue coagulation and devitalization across Veterans Affairs Medical Centers (VAMCs), particularly in operating rooms (OR), procedural suites, and endoscopy units. They deliver radiofrequency (RF) energy through specialized electrodes while directing a controlled flow of inert argon gas to create a conductive plasma at the tissue surface. This results in uniform, noncontact coagulation with minimal tissue penetration, improved visualization, and reduced bleeding. ESUs with AEC are designed to enhance surgical efficiency, improve hemostasis, and support consistent, replicable outcomes across a range of open, laparoscopic, and endoscopic procedures.

These systems provide real-time, automated control of power delivery, argon flow, and activation mode, with integrated safety monitoring and configurable presets for procedure-specific use. They are optimized to increase clinical efficiency and reduce complications through precision energy delivery, reliable tissue effect profiles, and comprehensive safety interlocks.

Offerors must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide an Electrosurgical Units (ESUs); Argon Enhanced Coagulation system to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for a 12-month base period and four 12-month option periods.

2. REQUIREMENT

This requirement will be solicited and awarded as a “Brand Name or Equal” which requires the quoter indicate that each product being offered as an “equal” product to the Erbe® VIO 3 Electrosurgical Units (ESUs); Argon-Enhanced Coagulation 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 conform to the solicitation requirements.

The following line-items comprise the Erbe® VIO 3 Electrosurgical Units (ESUs); Argon-Enhanced Coagulation system product line:

VIO® 3

Attachment Sets

Instrument cables from Erbe

VIO® 300 D

The VA is seeking offerors who can provide Erbe® VIO 3 Electrosurgical Units (ESUs); Argon-Enhanced Coagulation system or equal as listed above which meet all the following salient characteristics: Vendors may quote any product solution or configuration so long as they meet the salient characteristics.

Offerors may quote an alternative CLIN structure IAW FAR 4.202-2 and 4.202-3. Products quoted in the technical volume must appear on and correspond with the Offeror’s pricing volume (ATTACHMENT A - PRICE COST SCHEDULE - NX EQ Electrosurgical Units, Argon-Enhanced Coagulation).

Offerors may quote any additional ancillary products which they deem to be essential to the functionality of the quoted solution; these ancillary items must be quantified in the Offeror’s pricing volume with an estimated quantity of zero (0).

Only new equipment is acceptable; no remanufactured or "gray market" items. No product in development shall be considered. All items must be covered by the manufacturer's warranty.

Distributors must be authorized-distributors/resellers as certified by the Original Equipment Manufacturer (OEM) (i.e., OEM letter dated within 12 months of the solicitation close date and duly signed by OEM’s authorized representative) to be eligible for award. The OEM letter must be valid for the life of the contract.

CLIN’s 0001 apply to SC’s 0001-0004

SC – Literature Map (Brand Name/Page #)

Evaluation Sub-factors

1. Design: Design features and function will be evaluated based on, but not limited to, the following:

· Centralized touchscreen user interface: Large, color touchscreen with logical application-oriented men for quick selection and confirmation of modes to include APC settings.

· Multi-instrument connectivity and APC integration to include argon probes and APC hand pieces.

· Procedure and instrument-based presents: Recognizes instrument and procedure-specific programs that automatically load parameters and standardizes set-up.

2. Performance: Performance capabilities, features and functions of the device offered will be evaluated for technical performance, reliability, and clinical effectiveness. These elements include, but are not limited to:

· High dynamic power delivery: Power supply is able to maintain stable output under variable loads and APC modes.

· Rapid response measurement rate: High measurement of frequency of target tissue effects across different tissue types and cutting speeds supporting argon-assisted coagulation lines.

· Multi-modality support: Concurrent support for monopolar, bipolar, and hybrid/argon-assisted applications across platforms without swapping generators during an on-going procedure.

3. Safety: All features and functions of the equipment shall be evaluated for the ability to be safely installed, secured, and protected against harm; physical or any form. These elements include, but are not limited to:

· Regulatory compliance and clearances: FDA 510(K) clearance status.

· Systems and operational features safety related to electrical and argon-gas.

· Warning and alarms capability

4. Quality/Construction/Training: Elements will include, but are not limited to:

· Robust construction and medical-grade standards.

· Power consumption, backup power, and energy efficiency.

· Terms and conditions of installation, training, and service agreement programs.

· Expected life cycle to include sanitation, infection control, and maintenance.

3. 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 quoted under product refresh. The contractor will be notified in writing if a product refresh is not accepted. All products quoted 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.

The contractor shall provide the Contracting Officer’s Representative (COR) and Contracting Officer 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) quoted to be refreshed or upgraded.

(5) FDA approval, if applicable

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

(7) Copy of Commercial Warranty.

The request shall be submitted to the COR for review and recommendation of approval to be submitted to the Contracting Officer. The Contracting Officer shall prepare a bilateral modification for execution.

4. 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 agrees to take following steps immediately:

Notify the Contracting Officer at the Strategic Acquisition Center in writing, by the most expeditious manner possible.

Provide copies of the notification to the Contracting Officer, COR, and Manager at Product Recall Office, all Agencies and VA Facilities who purchased the product, which include, but not 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

5. DELIVERY

The Period of Performance will be from date of award for a base of 12-months with four 12-month option periods. Offerors will be required to deliver Electrosurgical Units, Argon-Enhanced Coagulation systems.

to VHA facilities located in the Continental United States (CONUS) and Outside of the Continental United States (OCONUS). Delivery requirements shall be specified under each individual order.

6. DATA RIGHTS

Commercial license agreements may be made a part of this Contract/Order but only if both parties expressly make them an addendum hereto, as permitted by FAR 12.107. If the commercial license agreement is not made an addendum, it shall not apply, govern, be a part of or have any effect whatsoever on the Contract/Order; this includes, but is not limited to, any agreement embedded in the computer software (clickwrap), any agreement that is otherwise delivered with or provided to the Government with the commercial computer software or documentation (shrink-wrap), or any other license agreement otherwise referred to in any document. If a commercial license agreement is made an addendum, only those provisions addressing data rights regarding the Government’s use, duplication and disclosure of data (e.g., restricted computer software) are included and made a part of this Contract/Order, and only to the extent that those provisions are not duplicative or inconsistent with Federal law, Federal regulation, the incorporated FAR clauses and the provisions of this Contract/Order; those provisions in the commercial license agreement that do not address data rights regarding the Government’s use, duplication and disclosure of data shall not be included or made a part of the Contract/Order. Federal law and regulation including, without limitation, the Contract Disputes Act (41 U.S.C. § 7101 et seq.), the Anti-Deficiency Act (31 U.S.C. § 1341 et seq.), the Competition in Contracting Act (41 U.S.C. § 3301 et seq.), the Prompt Payment Act (31 U.S.C. § 3901 et seq.), Contracts for Data Processing or Maintenance (38 USC § 5725), and FAR clause 52.212-4, 52.227-14 shall supersede, control, and render ineffective any inconsistent, conflicting, or duplicative provision in any commercial license agreement. In the event of conflict between this clause and any provision in the Contract/Order or the commercial license agreement or elsewhere, the terms of this clause shall prevail. The Contractor shall deliver to the Government all data first produced under this Contract/Order with unlimited rights as defined by FAR 52.227-14. Claims of patent or copyright infringement brought against the Government as a party shall be defended by the U.S. Department of Justice (DOJ) IAW 28 U.S.C. § 516; at the discretion of DOJ, the Contractor may be allowed reasonable participation in the defense of the litigation. Any additional changes to the Contract/Order must be made by modification (Standard Form 30) and shall only be made by a warranted Contracting Officer. Nothing in this Contract/Order or any commercial license agreement shall be construed as a waiver of sovereign immunity.

· ATTACHMENT A - PRICE COST SCHEDULE - NX EQ Electrosurgical Units, Argon-Enhanced Coagulation.

· ATTACHMENT B - CONTRACT ADMINISTRATION - NX EQ Electrosurgical Units, Argon-Enhanced Coagulation.

· ATTACHMENT C - CONTRACT CLAUSES - NX EQ Electrosurgical Units, Argon-Enhanced Coagulation.

· ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ Electrosurgical Units, Argon-Enhanced Coagulation.

· ATTACHMENT E – REPORTING TOOL - NX EQ Electrosurgical Units, Argon-Enhanced Coagulation.

· ATTACHMENT F - PAST PERFORMANCE QUESTIONAIRE - NX EQ Electrosurgical Units, Argon-Enhanced Coagulation.

· ATTACHMENT G - PAST PERFORMANCE REFERENCE - NX EQ Electrosurgical Units, Argon-Enhanced Coagulation.

See attached document: ATTACHMENT A PRICE COST SCHEDULE NX EQ NX EQ Electrosurgical Units Argon Enhanced Coagulation.

See attached document: ATTACHMENT B CONTRACT ADMINISTRATION NX EQ Electrosurgical Units Argon Enhanced Coagulation.

See attached document: ATTACHMENT C CONTRACT CLAUSES NX EQ Electrosurgical Units Argon Enhanced Coagulation.

See attached document: ATTACHMENT D SOLICITATION PROVISIONS NX EQ Electrosurgical Units Argon Enhanced Coagulation.

See attached document: ATTACHMENT E REPORTING TOOL NX EQ Electrosurgical Units Argon Enhanced Coagulation.

See attached document: ATTACHMENT F PAST PERFORMANCE QUESTIONNAIRE NX EQ Electrosurgical Units Argon Enhanced Coagulation.

See attached document: ATTACHMENT G PAST PERFORMANCE REFERENCE NX EQ Electrosurgical Units Argon Enhanced Coagulation.

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Combined Synopsis/Solicitation Notice