6515--NX EQ Image Guided Surgical Navigation System (VA-26-00026939)

Solicitation / RFP / RFQ

This document provides solicitation provisions for the "NX EQ Image-Guided Surgical Navigation System" procurement. It is a Full and Open Competition/Unrestricted solicitation.

• Offerors must provide technical documentation to demonstrate their ability to meet the requirements.

• Proposals must meet all minimum salient characteristics listed in Attachment B (Product Description).

• Only new original equipment manufacturer (OEM) parts are acceptable; no remanufactured or "gray market" items.

• Products in development will not be considered.

• All items must be covered by the manufacturer's warranty.

• Distributors must be authorized by the OEM and certified for maintenance, installation, and training, providing an OEM letter.

• The Government contemplates award of a Firm Fixed Price Requirements contract.

• The Service Level Agreement (SLA) fee is 3.0% and must be included in the price of every line item.

• Intent to Submit: Email to Contract Specialist Alanna Wilson and Contracting Officer Sara Vickroy by the date specified in SF1449, Block 20.

• Questions: Email to Alanna Wilson and Sara Vickroy by the date specified in SF1449, Block 20. Submit as a single Word document per contractor.

• Proposals: Submit via email to Alanna Wilson and Sara Vickroy by the date/time specified in SF1449, Block 8.

• Format: Proposals must be clearly indexed and logically assembled into five volumes: Technical, Past Performance, Veterans Preference, Price, and Offer/Amendments/Certifications/Representations.

• Page Limitations: Specific page counts apply to each volume. Font size, margins, and spacing requirements must be adhered to; violations may result in non-evaluation.

• File Packaging: Do not compress (zip) proposal files. Separate into multiple emails if necessary due to size restrictions.

• Evaluation Factors (Descending Order of Importance): Technical, Past Performance, Veterans Preference, and Price. Non-price factors are significantly more important than price.

• Technical Evaluation: Based on descriptive literature demonstrating meeting or exceeding salient characteristics. Subfactors include Safety, Design, Diagnostic Tools/Imaging Techniques, and Quality/Construction.

• Past Performance: Evaluated based on recent (last three years) and relevant contracts/orders. CPARS and PPQs will be used.

• Veterans Preference: Credit given for SDVOSB/VOSB participation. Offerors must be registered and certified by the SBA.

• Price Evaluation: Will assess if prices are fair and reasonable. Volume discounts are encouraged. Unbalanced pricing may lead to rejection.

• Offer Acceptance Period: Firm for at least 90 days from receipt.

• This solicitation is Full and Open Competition/Unrestricted.

• Evaluation credit is given for SDVOSB/VOSB participation (prime or subcontract).

• HUBZone small businesses receive a 10% price preference.

• Offerors are encouraged to submit offers no later than 5:00 PM one working day prior to the due date to account for Government infrastructure entry time.

• The Government reserves the right to award without communications based on initial evaluation.

• Proposals must include a statement of agreement with all terms and conditions. Deviations may render the proposal unacceptable.

Form / Attachment / Pricing Sheet

This document, "ATTACHMENT C - CONTRACT CLAUSES," outlines various contract clauses that will be incorporated into the agreement for the "NX EQ Image-Guided Surgical Navigation System" opportunity. It details mandatory disclosures, Service Level Agreement (SLA) fees and reporting, liquidated damages, ordering procedures, order limitations, requirements, option to extend terms, small business program rerepresentation, and clauses incorporated by reference.

• Mandatory Written Disclosures: Requires electronic submission of disclosures to the VA OIG Hotline.
• SLA Fee and Reporting: A 3.0% SLA fee must be included in offer prices and remitted quarterly. Quarterly sales reports are also required.
• Liquidated Damages: $37.50 per calendar day for failure to deliver or perform within the specified time.
• Ordering: Governs how delivery or task orders are issued and processed.
• Order Limitations: Specifies minimum and maximum order quantities.
• Requirements Contract: Defines the contract as a requirements contract with estimated quantities.
• Option to Extend: Allows the government to extend the contract term, with a maximum total duration of 5 years.
• Small Business Program Rerepresentation: Outlines requirements for contractors to represent their size and socioeconomic status, particularly for small businesses and joint ventures.
• Incorporated Clauses: Lists numerous FAR and VAAR clauses incorporated by reference, including those related to gratuities, restrictions on subcontractor sales, ethics, system for award management, small business utilization, labor laws, trade agreements, and equipment operation/maintenance manuals.
• Gray Market and Counterfeit Items: Prohibits used, refurbished, remanufactured, gray market, or counterfeit items. Vendors must be OEM or authorized resellers.
• Packing for Domestic Shipment: Specifies requirements for packing materials.
• Executive Order 13899 Compliance: Requires compliance with the Executive Order combating anti-Semitism.

This attachment is critical for bidders as it defines many of the contractual obligations, financial responsibilities (SLA fee), performance expectations (liquidated damages), and compliance requirements (small business, ethics, anti-Semitism) that will govern the contract. Understanding these clauses is essential for accurate proposal pricing, risk assessment, and ensuring compliance if awarded the contract.

Solicitation / RFP / RFQ

This document is a solicitation for a nationwide Requirements Contract for the Medtronic Stealthstation S8 Image-Guided Surgical Navigation System or an equivalent. The contract aims to procure the system, including accessories, consumables, installation, training, proctoring services, and annual warranty and maintenance services. The contract will be awarded to a single vendor.

• Procurement of the Medtronic Stealthstation S8 Image-Guided Surgical Navigation System or an equal product.

• Includes accessories, consumables, installation, training, proctoring services, and annual warranty and maintenance.

• The contract will cover ancillary items and installation, maintenance, repair services, and training.

• The Government may modify the contract to add or remove items within the scope of the solicited product line.

• Any discontinued items may be replaced via contract modification if the replacement serves the same clinical purpose.

• New technology may be evaluated for inclusion via bilateral modification.

• Installation includes setup, assembly, customized setup, training for clinical staff and biomedical engineers, and data integration setup.

• Software installation and updates are included, with non-exclusive licenses granted to the VA.

• Preventative Maintenance, repairs, and replacement will be performed by authorized technicians.

• Product refresh will be managed via contract modification to reflect newer versions of items.

• Product removal or recall due to defects will be handled by the manufacturer at no cost to the government.

• Contract Type: Requirements Contract

• Period of Performance: Base period of 12 months, with four 12-month option periods.

• Estimated Value: Not explicitly stated, but quantities in the CLIN table are estimates and not guaranteed.

• Proposal Due Date: May 4, 2026, 11:00 AM EDT.

• Questions Due Date: April 14, 2026, 09:00 AM EST.

• Proposals must be submitted electronically.

• Evaluation criteria are not detailed in this section.

• This acquisition is listed as "Unrestricted or Set Aside" with options for Small Business, HUBZone Small Business, Service-Disabled Veteran-Owned Small Business, Women-Owned Small Business (WOSB), and 8(A).

• NAICS Code: 334510

• Size Standard: 1250 Employees

• The contract is administered by the U.S. Department of Veterans Affairs, Strategic Acquisition Center.

• Payments will be made via Electronic Funds Transfer (EFT).

• Invoices must be submitted electronically via the Tungsten Electronic Invoice Submission program or X12 EDI formats.

• Monthly and quarterly reports are required, using ATTACHMENT E – REPORTING TOOL.

• A Business Associate Agreement (BAA) will be required for handling protected health information (PHI).

• Orders will be placed by designated VA Government Ordering Officers (OOs).

• Deliveries are FOB Destination.

• After Receipt of Order (ARO) is currently undetermined.

Solicitation / RFP / RFQ

This is a combined synopsis/solicitation for commercial products, issued as a Request for Proposals (RFP) under solicitation number 36C10G26R0009. The Department of Veterans Affairs, Strategic Acquisition Center - Frederick, is procuring NX EQ Image-Guided Surgical Navigation Systems. This announcement constitutes the only solicitation; no separate written solicitation will be issued.

• Offerors must provide new, Original Equipment Manufacturer (OEM) NX EQ Image-Guided Surgical Navigation Systems.

• Refurbished, remanufactured, or gray market items are not acceptable.

• Salient characteristics are detailed in ATTACHMENT B – PRODUCT DESCRIPTION.

• Line items, quantities, and units of measure are specified in ATTACHMENT A - PRICE COST SCHEDULE.

• Delivery is FOB Destination, with specific locations and dates to be identified in individual orders.

• The acquisition is unrestricted.

• Specific contract type, period of performance, and estimated value are not detailed in this synopsis.

• Proposals are requested by 05-04-2026 at 11:00 am Eastern Time, New York, USA.

• The solicitation incorporates provisions and clauses by reference, accessible at www.acquisition.gov.

• Evaluation criteria are not detailed in this synopsis.

• This acquisition is unrestricted.

• Numerous attachments are provided, including Price Cost Schedule, Product Description, Contract Clauses, Solicitation Provisions, Quarterly Sales Reporting Tool, Past Performance Questionnaires and References, and a Certification of Recall or Safety Issues.

Form / Attachment / Pricing Sheet

This document is a "Certification of No Outstanding Recalls or Safety Issues" form required for the solicitation of the NX EQ Image-Guided Surgical Navigation System (Solicitation Number: 36C10G26R0009).

• Company Unique Entity Identifier (UEI): To be filled in by the offeror.
• Certification Statement: The undersigned representative must certify that the medical equipment quoted:
  • Does not have any outstanding recalls.
  • Does not have any known safety issues.
  • Complies with all relevant regulations and standards for medical equipment.
  • Has been thoroughly checked for compliance with safety and performance standards.
• Authorized Representative Details: Fields for Name, Title, Signature, and Date.

Bidders must complete and sign this form, providing their UEI and certifying the safety and compliance of the medical equipment they are quoting. This completed form must be submitted along with the proposal. Failure to provide accurate information may lead to disqualification.

Form / Attachment / Pricing Sheet

This document, Appendix C of VA Handbook 6500.6, provides standard Information Security and Privacy Language for inclusion in VA contracts. It outlines requirements for contractors regarding the handling, protection, and security of VA information and information systems.

• General Applicability: Applies to all acquisitions requiring Information Security and Privacy language.
• VA Information Custodial Language: Details contractor responsibilities for using, storing, and transmitting VA sensitive information, including encryption requirements (FIPS 140-2, NIST 800-52), data segregation, and co-mingling restrictions.
• Access to VA Information and Systems: Outlines requirements for contractor personnel needing access, including security investigations, clearances, and signing a Rule of Behavior.
• Training: Mandates specific VA Privacy and Information Security Awareness training for all personnel requiring access.
• Security Incident Investigation: Defines procedures for reporting and investigating security/privacy incidents, including required information and cooperation with VA and law enforcement.
• Data Breach Costs: States contractor liability for liquidated damages in case of a data breach involving VA sensitive personal information.

This document establishes critical security and privacy obligations that potential bidders must understand and be prepared to comply with if awarded a contract. It details requirements for data handling, access control, personnel training, and incident reporting, which will impact operational procedures and potentially costs.

Form / Attachment / Pricing Sheet

This document is a Past Performance Questionnaire (PPQ) for Solicitation No. 36C10G26R0009, concerning the NX EQ Image-Guided Surgical Navigation System. Its purpose is to gather feedback from references provided by offerors regarding their past performance on previous contracts.

• Offeror Information: Space to insert the Offeror's Name and Contract Number.
• Reference Information: Fields for the reference to provide their name, title, organization, contact details, and contract period/value.
• Contract Details: Questions regarding options exercised, services/commodities provided, and any Show Cause, Stop Work, or Termination orders.
• Rating Guidelines: A scale (1-3) for evaluating Quality of Service, Cost Control, Timeliness of Performance, and Business Relations.
• Offeror Evaluation: Sections for the reference to rate the offeror in each category and provide detailed comments. Includes an "Overall Satisfaction" question asking if the reference would work with the offeror again.

This questionnaire is crucial for offerors to identify appropriate references and ensure their references can provide positive and detailed feedback. The information gathered from these questionnaires will be a significant factor in the government's evaluation of the offeror's past performance. Offerors should proactively communicate with their references about the requirements of this questionnaire and the importance of timely submission. The deadline for submission is May 4, 2026, at 11:00 am EST, via email to Alanna.Wilson@va.gov and Sara.Vickroy@va.gov.

Form / Attachment / Pricing Sheet

This document, "ATTACHMENT B - PRODUCT DESCRIPTION," details the product requirements for an Image-Guided Surgical Navigation System. It serves as a product description for non-expendable equipment and outlines the "Brand Name or Equal" requirement for the solicitation.

• Scope of Work: Describes the Image-Guided Surgical Navigation System as a candidate for a VA-wide single Requirements contract, designed to aid in minimally invasive procedures by combining medical imaging, computer software, and instrument tracking for real-time guidance.
• Requirement: Specifies that the requirement is "Brand Name or Equal" for the Medtronic Stealthstation S8 Image-Guided Surgical Navigation System or an "equal" product. Offerors must provide a description of salient characteristics, brand name/model number, and descriptive literature. Authorization from the OEM for installation, maintenance, and training is required.
• Product List: Contains an extensive list of specific Medtronic part numbers, brand names, and detailed descriptions of components, accessories, software, and service agreements related to the Stealthstation S8 and other related systems.

This document is critical for potential bidders as it defines the specific product and its components that the government is seeking. Bidders must use this list to identify their proposed "equal" products or configurations, ensuring they meet all listed salient characteristics and requirements. The detailed product list helps bidders understand the scope of the required system and any necessary ancillary items or services.

Form / Attachment / Pricing Sheet

This document is a pricing and cost schedule for the opportunity. It details the CLINs, item descriptions, units of measure, quantities, and pricing for various medical equipment and accessories. Bidders are expected to use this format to provide their proposed pricing.

• CLIN: Contract Line Item Number.
• Item Description: Specific product or service being priced (e.g., STEALTHSTATION™ S7 to S8 Upgrade, STEALTHSTATION™ S8 New).
• Unit of Measure (UOM): The unit for the item (e.g., Each).
• Estimated Quantity: Quantity required for the Base Year and Option Years 1-4.
• Manufacturer Part Number & Name: Identifies the original equipment manufacturer.
• Commercial Price / Proposed Unit Price: Fields for bidders to enter their pricing for each year.
• SLA (3%): Service Level Agreement percentage.
• Total Price (Unit Price plus SLA): Calculated total price.
• Total Evaluated Price: Calculated total evaluated price for each year and overall.
• Yellow Highlighted Spaces: Indicate areas where the vendor is required to input pricing information.

This sheet is critical for bidders as it outlines the specific items and quantities for which pricing is required. Bidders must accurately complete the 'Proposed Unit Price' and related fields for each CLIN to submit a compliant quote. The estimated quantities and the structure of the schedule will guide the bidding process and cost proposal preparation.

Form / Attachment / Pricing Sheet

This document, "ATTACHMENT G - PAST PERFORMANCE REFERENCE_NX EQ Image-Guided Surgical Navigation System.docx", is a template for bidders to provide past performance references. It is intended to collect detailed information about previous contracts or subcontracts performed by the offeror or its subcontractors.

• Past Performance Reference Sections: The document provides three distinct sections, each for a separate past performance reference.
• Offeror Information: Fields for the Offeror Name and the company that performed the work.
• Relationship to Offeror: Specifies if the performing company was the Offeror or a Subcontractor.
• Role on Contract: Indicates if the performing company was the Prime or Subcontractor.
• Contract Details: Requires information such as the Contracting Organization, Contract/Task Order Number, Contract Type, Total Awarded Price/Cost, Final or Projected Final Total Price/Cost, and Period of Performance.
• Contact Information: Fields for Contracting Officer and Program Manager names, emails, and telephone numbers.
• NAICS Code: Space to record the relevant North American Industry Classification System code.
• CPARS/PPIRS: A field to indicate if CPARS/PPIRS were completed.
• Description of Requirement: A section for a concise explanation of the work performed and its relevance to the current solicitation.
• Performance Issues: A section to detail any performance issues, corrective actions, and results, especially if discussed in CPARS/PPIRS.

Bidders must complete this form for each relevant past performance reference they wish to submit. The information provided will be used by the government to evaluate the offeror's demonstrated ability to successfully perform the requirements of the solicitation. Failure to provide complete and relevant information may negatively impact the evaluation of the offeror's past performance.