6515--Ophthalmic A/B-Scan–Pachymeter Ultrasound ***BRAND NAME OR EQUAL***

This Sources Sought Notice is for informational and planning purposes only and shall not be construed as a solicitation or as an obligation or commitment by the Government. This notice is intended strictly for Market Research. This is a Request for Information only. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The Department of Veterans Affairs El Paso Veterans Medical Center in El Paso, Texas intends to award a brand name or equal contract award for the purchase of Ophthalmic A/B-Scan Pachymeter Ultrasound. The Government is conducting a market survey to help determine the availability and technical capability of qualified service-disabled veteran-owned small businesses, veteran-owned small businesses, small businesses, HUBZone small businesses and/or other large businesses capable of serving the needs identified below. This notice of intent is for open market as well as Federal Supply Schedule items. The purpose of this notice is to gain knowledge of potential qualified sources and their size classification/socioeconomic status (service-disabled veteran owned small business, veteran owned small business, women owned small business, HUB Zone, 8(a), small business or large business, relative to NAICS 339112 with a size standard of 1,000 employees. Responses to this notice will be used by the Government to make appropriate acquisition decisions. A solicitation is not currently available. If a solicitation is issued, it will be announced on Federal Business opportunities website http://www.fbo.gov or GSA E-Buy at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. ITEM NUMBER DESCRIPTION OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT 0001 1.00 EA A/B Scan-Pachemetry Ultrasound ***BRAND NAME OR EQUAL*** 0002 1.00 LT Installation and operation training ***BRAND NAME OR EQUAL*** Statement of Work (SOW) ***BRAND NAME OR EQUAL*** Procurement of Ophthalmic A/B-Scan Pachymeter Ultrasound System ***BRAND NAME OR EQUAL*** 1. Purpose The purpose of this Statement of Work (SOW) is to define the requirements for the purchase of one fully operational Ophthalmic A/B-Scan Pachymeter Ultrasound System for the El Paso VA Health Care System (EPVAHCS). This acquisition supports diagnostic imaging and biometric measurement needs of Ophthalmology. The purchase includes equipment delivery, installation, system verification, and training. 2. Scope The Contractor shall provide delivery, installation, calibration, training, manuals, warranty support, and accessories required for full operation. Salient Characteristics The purchase description below identifies the requirement in terms that enable contractors to offer commercial supplies or services. The description is not restrictive and not be limited to one product peculiar to a manufacturer (e.g., by manufacturer, brand name and Part Number) unless it is essential to the Government s minimum requirement. A purchase description below includes the following characteristics based on the requirement to adequately describe the Government s needs: a Common Nomenclature (commercial description): Ophthalmic A/B-Scan-Pachymeter System b Kind of material (i.e., type, grade, alternatives, etc.): System Type: A portable, tablet-based workstation running on a Windows 10 platform with a high-resolution, multi-touch screen. A-Scan Probe: Typically includes a 10 MHz A-probe, which can be configured for either immersion or soft-touch (direct contact) material methods. B-Scan/UBM Probes: The code suffix refers to specific transducer frequencies: 20 MHz: The "20" in the code signifies a 20 MHz high-resolution B-scan transducer, often used for posterior segment imaging with enhanced focus. 50 MHz: The "50" indicates the inclusion of a 50 MHz UBM (Ultrasound Biomicroscopy) probe, designed for high-resolution imaging of the anterior segment of the eye. Physical Construction: The device features a medical-grade tablet housing with an adjustable angle kickstand and is compatible with VESA brackets for wall or articulating arm mounting. c Electrical Data (i.e., 110 v, 60 Hz, 3 Ph, etc.): Power Supply: Uses a medical-grade, auto-switching power supply. Input Voltage: 100 - 240 VAC. Input Frequency: 50 / 60 Hz. Operating System Platform: Runs on a Windows 10 platform. Connectivity: Equipped with full network capabilities, including dual-band Wi-Fi, Ethernet, USB, and Bluetooth. Display: Features an ultra-high-resolution multi-touch screen. d Dimensions, size, capacity: Dimensions: 13.3" w x 8.0" d x 2.0" h (33.8 cm x 20.3 cm x 5.1 cm) Weight: Approximately 4.5 lbs (2.1 kg) Screen Size: 10.1" high-resolution multi-touch monitor (1280 x 800px)  Mounting: Includes an adjustable angle kickstand and a VESA bracket for mounting on an articulating arm or wall. e Principles of operation listed with subcategories in detail: Pulse-Echo Imaging: The system transmits high-frequency sound waves through an ultrasound transducer (probe). These waves reflect off internal eye structures (echoes), which the transducer then receives and converts into electronic signals for processing. A-Scan (Amplitude Scan): Operates as a one-dimensional (linear) measurement tool. It measures the time delay of echoes to calculate distances along the visual axis, determining parameters like axial length (AL), anterior chamber depth (ACD), and lens thickness for intraocular lens (IOL) power calculations. B-Scan (Brightness Scan): Uses an oscillating sound beam to create a two-dimensional cross-sectional image of the eye. The intensity of returning echoes is represented by the brightness of dots on the screen, allowing for the diagnosis of retinal detachment, vitreous hemorrhage, and tumors. Enhanced Focus Rendering: A proprietary digital processing technology that enhances image quality by sampling over 500,000 points per transducer sweep, providing high-definition resolution for both posterior and anterior segment imaging.  Biometric A-Scan: Includes 9 IOL formulas (6 standard, 3 post-refractive) and manual or automatic capture modes (cataract, aphakic, silicone oil, etc.). Pachymetry: Uses ultrasonic pulses to measure corneal thickness for glaucoma screening and refractive surgery planning. Operating Interface: Runs on a Windows 10 platform with a multi-touch screen. It features real-time video capture (50 frames at 20 fps) and "Al-Assist Eye Tracking" for automated scan alignment.  f Restrictive environmental conditions: Temperature: Typically requires a standard clinical range of 10°C to 35°C (50°F to 95°F). Relative Humidity: Generally restricted to 30% to 75% (non-condensing). Atmospheric Pressure: Designed for operation between 700 hPa and 1060 hPa. Flammable Environments: The  VuPad is not AP/APG rated and must not be used in the presence of flammable anesthetic mixtures with air, oxygen, or nitrous oxide due to explosion risks. EMI/EMC Interference: Avoid use near high-frequency surgical equipment or MRI systems. Portable RF communications equipment (including peripherals like antenna cables) should be used no closer than 30 cm (12 inches) to any part of the VuPad system. Power Requirements: Must be connected to a 100-240 VAC, 50/60 Hz auto-switching medical-grade power supply to maintain electrical safety. Ingress Protection: Probes are typically sealed, but the console itself must be kept away from excessive moisture or liquid splashes to protect the internal Windows-based hardware. g Intended use: A-Scan (Biometry): Measures axial length (AXL), anterior chamber depth (ACD), and lens thickness to calculate Intraocular Lens (IOL) power for cataract surgery. B-Scan (Imaging): Creates real-time, two-dimensional images to visualize pathologies in the posterior chamber, such as: Retinal detachment Vitreous hemorrhage (hemophthalmos) Intraocular tumors (neoplasms) Diabetic changes in the vitreous and retina Other hidden ocular diseases or trauma Pachymetry & UBM: Can also be configured with Ultrasound Biomicroscopy (UBM) and Pachymetry for detailed anterior segment imaging and corneal thickness measurement.  h Equipment with which the item is used with (N/A if not applicable): N/A i End item application: Diagnostic Imaging (B-Scan): Produces high-resolution, two-dimensional cross-sectional images of the posterior chamber. It is used to identify and measure ocular pathologies such as retinal detachment, vitreous hemorrhages, and tumors, especially when clear visualization is blocked by cataracts or other opacities. Biometry and IOL Calculation (A-Scan): Measures critical ocular dimensions including axial length (AXL), anterior chamber depth, and lens thickness. These measurements are used to calculate the necessary power for Intraocular Lens (IOL) implants during cataract surgery. Anterior Segment Imaging (UBM): Utilizing high-frequency (35-50 MHz) Ultrasound Biomicroscopy (UBM) to visualize the anterior segment, including the iris, ciliary body, and angle, which is essential for glaucoma management and ICL (Implantable Collamer Lens) sizing. Corneal Pachymetry: Measures corneal thickness, which is a standard procedure for preoperative LASIK screenings and glaucoma risk assessment.  j Existing equipment manufacturer part number: ***BRAND NAME OR EQUAL*** k Other pertinent information that describes the item, material or service required: Calibration, software update, or hardware check, requiring contact with a service provider or distributor for professional servicing to ensure accuracy, potentially involving probe checks, system diagnostics, or repairs, as it's a high-tech device with A-scan, B-scan, and UBM functions. Facility POC: TBD 3. Location Delivery location: VA Warehouse 6 Founders, Suite B, El Paso VA 79906 4. Performance Requirements The contractor shall provide equipment that meets all specified salient characteristics and is fully functional upon delivery, installation, and acceptance. The system shall perform in accordance with manufacturer specifications and intended clinical use without degradation in accuracy or reliability. Vendor shall provide 2 copies of the operations manual. 4.1 Equipment Performance The system shall demonstrate full operational capability during acceptance testing, including A-Scan, B-Scan, UBM, and pachymetry functions. All measurements and imaging outputs shall meet manufacturer accuracy standards and be suitable for clinical application. 4.2 Installation and Operational Readiness The contractor shall ensure the equipment is properly installed, configured, calibrated, and verified as fully operational. Successful completion of installation and functional verification shall be required prior to Government acceptance. 4.3 Warranty Coverage The equipment shall be covered under the manufacturer s standard commercial warranty for a minimum period of one (1) year from the date of Government acceptance. During the warranty period, the contractor shall ensure that any defects in materials or workmanship are corrected through repair or replacement at no additional cost to the Government. 4.4 Warranty Support Limitations Warranty support is limited to corrective actions necessary to restore the equipment to proper operating condition. No preventive maintenance, recurring service, or extended support beyond the standard warranty is required under this contract. 4.5 Acceptance Criteria Acceptance shall be based on successful completion of installation, operational testing, and verification that the equipment meets all technical and functional requirements outlined in this Statement of Work. 5. Equipment Requirements The system must meet or exceed the salient characteristics including A-Scan, B-Scan, UBM, pachymetry, connectivity, Windows 10 platform, and medical grade construction. 6. Maintenance & Service Vendor shall perform preventive maintenance, provide technical support, and respond to repair needs per manufacturer specs for 1 year. 7. Safety Requirements Vendor must notify COR of any software, probe, or safety related updates or recalls. 8. Test Performance Requirements Equipment must operate within manufacturer specifications and be evaluated for accuracy through clinical validation. 9. Period of Performance Period begins upon delivery and installation, extending through warranty term. 10. Deliverables A/B Scan Pachymeter System, probes, accessories, manuals, and initial training. 11. Security Requirements (VA Handbook 6500.6) No VA data may be removed from VA systems; device does not require interconnection. Vendor personnel must follow VA privacy and security rules. 12. Records Management Requirements All records generated are federal records and must comply with NARA, FOIA, and Privacy Act regulations. 12.1 NARA Records Management Language for Contracts Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. El Paso Veteran Affairs Health Care System (EPVAHCS) and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of EPVAHCS or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to EPVAHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to EPVAHCS control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and EPVAHCS guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with EPVAHCS policy. The Contractor shall not create or maintain any records containing any non-public EPVAHCS information that are not specifically tied to or authorized by the contract. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act. The EPVAHCS owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which EPVAHCS shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take VHA-provided records management training, Talent Management System (TMS) Item #10176, Privacy and Information Security, Rules of Behavior. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. 9. Personnel Qualifications Vendor personnel must be qualified field service representatives experienced in ophthalmic diagnostic imaging systems. 10. Performance Standards & Quality Assurance (QASP) Performance will be monitored through safety compliance, response times, documentation accuracy, and customer satisfaction metrics.