6515--COMPREHENSIVE VESTIBULAR TESTING SYSTEM. "BRAND NAME OR EQUAL TO NATUS IAW SOW". OEM LETTER FROM THE MANUFACTURER IS REQUIRED. IF NO OEM LETTER VENDOR WILL BE CONSIDERED NONRESPONSIVE.

Form / Attachment / Pricing Sheet

This document, VAAR 852.212-71, addresses Gray Market and Counterfeit Items for procurements. It outlines the government's requirements regarding the origin and authenticity of supplies and equipment.

• New OEM Items Only: Procurement is restricted to new Original Equipment Manufacturer (OEM) items. Used, refurbished, or remanufactured items are not permitted.
• Gray Market Prevention: Prohibits the provision of gray market items, defined as OEM goods sold outside authorized territories or by non-authorized dealers.
• Counterfeit Prevention: Prohibits counterfeit supplies or equipment, including unauthorized reproductions, substitutions, or alterations that misrepresent the item's authenticity or origin.
• Vendor Authorization: Vendors must be an OEM, authorized dealer, authorized distributor, or authorized reseller, verified by OEM documentation. This includes ensuring all associated software licensing, warranty, and service align with OEM terms.

Bidders must ensure that all proposed equipment and supplies strictly adhere to these requirements. Failure to comply could lead to disqualification. Vendors need to be prepared to provide documentation verifying their authorization to supply the specified OEM products and confirm that the items are not gray market or counterfeit.

Form / Attachment

This document is the 52.225-2 BUY AMERICAN CERTIFICATE (OCT 2022) provision, which bidders must complete as part of their offer. It requires certification regarding the origin of end products to comply with the Buy American Act.

• Certification of Domestic End Products: Offerors certify that all end products are domestic, except those explicitly listed as foreign.

• Listing Foreign End Products: Bidders must list foreign end products by line item number, country of origin, and indicate if they exceed 55% domestic content (unless COTS items). If domestic content percentage is unknown, 'no' should be selected.

• Listing Domestic End Products with Critical Components: Bidders must separately list line item numbers for domestic end products that contain a critical component.

• Definitions: Key terms like "commercially available off-the-shelf (COTS) item," "critical component," "domestic end product," "end product," and "foreign end product" are defined in the solicitation's "Buy American—Supplies" clause.

• Mandatory Completion: This certificate is a required part of the proposal submission.

• Evaluation Impact: The Government will evaluate offers based on the information provided in this certificate, in accordance with the policies and procedures of FAR Part 25 (Foreign Acquisition).

• Compliance: Accurate completion is crucial for demonstrating compliance with Buy American Act requirements and ensuring proper evaluation of the offer.

Form / Attachment / Pricing Sheet

This document provides the text for FAR Clause 52.225-1, "Buy American-Supplies," and related provisions and clauses. It outlines the conditions under which these clauses are to be inserted into solicitations and contracts.

• 52.225-1 Buy American-Supplies Clause: Details the requirements for domestic end products and specifies domestic content thresholds that will increase over time (60% for 2022-2023, 65% for 2024-2028, 75% after 2028).
• 52.225-2 Buy American Certificate Provision: To be inserted in solicitations containing 52.225-1.
• 52.225-3 Buy American-Free Trade Agreements-Israeli Trade Act Clause: Outlines conditions for its use based on acquisition value and type, including different alternates for varying dollar thresholds and domestic content requirements.
• 52.225-4 Buy American-Free Trade Agreements-Israeli Trade Act Certificate Provision: To be inserted in solicitations containing 52.225-3.
• 52.225-5 Trade Agreements Clause: For solicitations and contracts valued at $174,000 or more, if covered by the WTO GPA and Buy American statute restrictions are not applicable.
• 52.225-6 Trade Agreements Certificate Provision: To be inserted in solicitations containing 52.225-5.
• 52.225-7 Waiver of Buy American Statute for Civil Aircraft and Related Articles Provision: For solicitations of civil aircraft and related articles valued less than $174,000.
• 52.225-8 Duty-Free Entry Clause: For supplies imported into the U.S. where duty-free entry may be obtained.
• 52.225-18 Place of Manufacture Provision: For solicitations predominantly for manufactured end products.

This document is critical for bidders as it defines the Buy American Act requirements, including domestic content thresholds and the applicability of Free Trade Agreements. Understanding these clauses is essential for ensuring compliance and accurately preparing proposals, especially concerning the origin of supplies and potential price impacts.

Statement of Work (SOW) / Performance Work Statement (PWS)

To procure one (1) comprehensive vestibular testing system for the VA Maryland Health Care System at the Baltimore VA Medical Center to replace an outdated and non-functional system, ensuring continued proper care for veteran patients.

• Deliver and install a new, comprehensive vestibular testing system, including all specified salient characteristics. Only new equipment will be accepted.

• Provide shipping, transport, and installation services.

• Assemble and validate the system by a vendor-service trained representative.

• Identify and include any missing parts or components necessary for full system potential.

• Include specified accessories and consumables.

• Vestibular Testing System (ICS Dizcovery System equivalent or exceeding Natus ICS Dizcovery System):

  • Operating System: 64-bit, Windows 10 Pro or above.
  • Memory: At least 8 GB.
  • Disk Space: At least 250 GB.
  • Monitor Resolution: At least 1600 x 900 at 100% DPI.
  • Goggles: Dual cameras, fixation LEDs, color-coded nystagmus beats, specific dimensions (no larger than 6.8" x 7.3" x 4.8"), wavelength at least 650 nm (+20 nm), weight no more than 395g (top mount no more than 345g with cover), sampling rate at least 60 fps, eye movement resolution at least 0.22 degrees (top mount at least 0.3 degrees).
  • Includes remote control.

• AirCal System (1079 AirCal Caloric Stimulator equivalent or exceeding Natus 1079 AirCal Caloric Stimulator):

  • Recording window of at least 150 ms.
  • Capability to monitor VEMP within the ABR system.
  • Tests include ecochg, abr, mlr, and Ilr/cae.
  • PC size no larger than 15" x 12.6" x 2.2".
  • Weight no larger than 5.5 lbs (excluding accessories).
  • Noise level up to 125 db.
  • System level between 20 – 140 db pespl.
  • Tone burst frequency includes 250, 500, 750, 1000, 1500, 2000, 3000, and 4000 Hz.
  • Tone burst stimulation time up to 780 ms.
  • Stimulus rate: 0.1 – 200 per second.
  • Option for a mobile cart.

• ABR Testing System (DUET 2 equivalent or exceeding Intelligent Hearing Systems DUET 2):

  • Air cooling down to at least 20°C, heating up to 50°C.
  • Air flow stability within + 0.5 L/Min.
  • Self-containing cooling ability.
  • Integrates with VNG System.
  • Accuracy of at least + 0.4 Degrees C.
  • Weight no greater than 18 Lbs.
  • Quiet setting reaching at least 49 Db.
  • Ability to reach 50°C from 40°C in 3 minutes or less.
  • Air flow rate: 4-10 L/Min.
  • Otoscope speculums: 2.75mm and 4.25mm.
  • Ability to deliver audible and visual cues.
  • Size no greater than 13.5" x 12" x 4".

• Accessories: As detailed in the document.

• Notebook Computer: Minimum specifications provided (Windows 32- or 64-bit, 4GB RAM).

• Operation and Maintenance Manuals: Provided in electronic format.

• Delivery is expected within 60 days ARO (After Receipt of Order).

• Delivery location: Baltimore VA Medical Center, 10 North Green Street, Baltimore, MD 21201.

• Installation and Validation: Included in procurement cost, performed by vendor service trained representative.

• Training: Onsite training for VAMHCS staff (clinical, facilities, engineering, biomedical engineering).

• Delivery Coordination: 3 weeks' notice required; coordinate deliveries, installation, and parking with the COR.

• Inspection: Joint inspection with COR upon delivery; contractor to provide list of missing/damaged items.

• Protection of Property: Contractor responsible for protecting items and premises from damage.

• Security: Photo ID required; contractor responsible for PPE.

• COVID-19 Guidance: Must follow current VA Maryland Health Care Systems guidance.

• Warranty: Minimum 1-year warranty on parts and labor (additional years recommended). Includes onsite repairs, over-the-phone support, routine maintenance, and all travel/shipping costs for repairs. Warranty begins upon completion of validation testing.

• Contract Type: Firm-Fixed Price.

• Brand name or equal to Natus IAW SOW.

• OEM distributor/authorization letter required.

• Must complete Buy American Certificate (FAR 52.225-2).

• Agency intention to provide price preference for domestic end products.

• Price.

Solicitation / RFP / RFQ

This document is a Request for Information (RFI) for a Comprehensive Vestibular Testing System for the Baltimore VA Medical Center (VAMC). The VAMC requires a replacement for its current, end-of-life vestibular testing system to ensure continued patient care for balance and dizziness disorders. This RFI is for information and planning purposes, but responses are highly encouraged.

• Procurement of one (1) comprehensive vestibular testing system, including associated software, a TV, installation, and potentially an air caloric.

• The system must be technically equivalent to or exceed the Natus ICS Dizcovery System, Natus 1079 AirCal Caloric Stimulator, and Intelligent Hearing Systems DUET 2.

• Specific technical requirements for each component are detailed in the Statement of Work (SOW), including operating system, memory, screen resolution, goggle specifications, and caloric stimulator capabilities.

• Delivery is required within 60 days from contract award to the Baltimore VA Medical Center warehouse.

• New equipment only will be accepted.

• Installation and validation by a vendor-trained representative are required.

• A 1-year minimum warranty on all parts and labor is required, starting upon completion of validation testing.

• Contract Type: Firm-Fixed Price (FFP).

• Delivery: Within 60 days After Receipt of Order (ARO).

• Responses must be submitted via email to Mohsin.Abbas2@va.gov by January 30, 2026, 12:00 PM EST.

• Vendors must answer all 14 questions provided in the RFI to qualify.

• Key evaluation factors include: Brand name or equal to Natus IAW SOW, OEM authorization letter, Buy American Certificate completion, and Price. A price preference will be given for domestic end products.

• Vendors must be registered in the System for Award Management (SAM).

• Small business status and representations (SDVOSB, VOSB, HUBZone, WOSB, etc.) must be indicated.

• An OEM distributor/authorization letter from the manufacturer is mandatory for all responses; otherwise, the vendor will be considered non-responsive.

• SDVOSB and VOSB categories must be verified on the SBA website.

• This RFI is for market research to determine acquisition strategy and potential for competition or set-aside.

• The government reserves the right to reject any input and is not obligated to notify respondents of results.

• The document references several attachments, including the SOW, Buy American certificates, and line-item descriptions.

Form / Attachment / Pricing Sheet

This document is a Price/Cost Schedule detailing specific line items for supplies and services. It is intended to outline the "Brand Name or Equal" requirements for a "Comprehensive Vestibular Testing System" in accordance with a Statement of Work (SOW).

• Item Information: A list of 17 distinct items, each with a unique item number, description of supplies/services, quantity, unit, and fields for unit price and amount.
• Specific Items: Includes systems like the "ICS DIZCOVERY SYSTEM," "ICS DIZCOVERY PRO PLUS," "ICS DIZCOVERY UNIVERSAL FACE CUSHION," "ICS DIZCOVERY CRADLE," "AIRCAL CALORIC STIMULATOR," "DUET 2 CHANNEL AEP BASE UNIT," "SMART EP SOFTWARE," "ER3C INSERT EARPHONES," "DD45-300 HEADPHONES," "BONE VIBRATOR," "DUET 5 ELECTRODE LEADS PATIENT CABLE," "COMPACT CART FOR THE HIS DUET EP SYSTEM," "120V ISOLATION TRANSFORMER," "PRINTER- B&W LASER."
• Training: Item 0006 specifies "AUD TRAINING-1/2 DAY."
• "Brand Name or Equal" Specification: All items are specified as "BRAND NAME OR EQUAL TO NATUS IAW SOW."
• Contract Type: All items are listed as "FIRM-FIXED PRICE."
• NAICS & PSC Codes: Primarily uses NAICS Code 339112 (Surgical and Medical Instrument Manufacturing) and Product/Service Code 6515 (Medical and Surgical Instruments, Equipment, and Supplies).
• Manufacturer Part Numbers (MPN): Each item includes a specific manufacturer part number.

This document is crucial for bidders as it defines the specific equipment, software, and training required for the opportunity. Bidders must ensure their proposed solutions meet or exceed the "Brand Name or Equal" specifications, particularly referencing the NATUS system, and provide pricing for each line item. The detailed list of components and associated part numbers will guide proposal preparation and ensure compliance with the government's needs.