6540--NX EQ Scanning Systems Ultrasonic Ophthalmic AB Scan (VA-27-00003110)

Sources Sought Notice Sources Sought Notice Page 5 of 5 Sources Sought Notice *= Required Field Sources Sought Notice Page 1 of 5 DESCRIPTION DESCRIPTION The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Scanning Systems Ultrasonic Ophthalmic AB Scan product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract award. The Department of Veterans Affairs (DVA) Office of Procurement, Acquisition and Logistics (OPAL) Enterprise Procurement Office (EPO) on behalf of VHA is issuing this Sources Sought Notice in accordance with the FAR 10.002(b)(2) to determine the availability and technical capabilities of qualified sources. The EPO in conjunction with VHA is seeking a qualified source to provide Lumibird® Absolu and the Lumibird® Compact Touch II brand name or equal Scanning Systems Ultrasonic Ophthalmic AB Scan on an agency wide basis. VA intends to award a Requirements Contract with Firm-Fixed Price (FFP) orders IAW FAR 16.503, Requirements Contract to a supplier of this equipment. Vendors will be required to deliver the Scanning Systems Ultrasonic Ophthalmic AB Scan to VA medical centers and facilities throughout the United States and its territories. The anticipated period of performance is for one 12-month base period with four 12-month option periods from the date of award. However, the Government's decision as to whether to continue with the contract, upon annual review, will be based upon successful performance during each previous year and continued need. The Contractor must demonstrate the ability to meet all requirements for the solicitation. The associated North American Industrial Classification System (NAICS) code for this procurement is 339115- Ophthalmic Goods Manufacturing, Product Service Code: 6540 Ophthalmic Instruments, Equipment and Supplies, and the associated size standard is 1,000 employees. The FAR Provision found at 52.204-7(b)(1) requires that All interested Offerors must be registered in SAM.gov prior to submitting an offer or quotation. You may access the website at SAM.gov | Home. All offerors must be certified with the appropriate NAICS code on the SAM website. All SDVOSB/VOSB offerors must be verified in the SBA database at: https://veterans.certify.sba.gov/#search at the time of quote submission. This notice is for planning purposes only and does not constitute a commitment on the part of the Government to award a contract, nor does the Government intend to pay for any information submitted as a result of this notice. This Sources Sought Notice is part of a continuous process for obtaining the latest information on the commercial status of the industry with respect to their current and near-term abilities. The information provided herein is subject to change and in no way binds the Government to solicit for, or award, a competitive contract. It is emphasized that this is a notice solely for planning and informational purposes. 2.0 SCOPE Ophthalmic A-B Scan systems are diagnostic ultrasonic devices that use sound waves to create images of the eye's internal structures, with the A-scan (amplitude/time-amplitude) displaying a one-dimensional graph of tissue interfaces and the B-scan (brightness/brightness modulation) providing a two-dimensional cross-sectional image. They are used for diagnosing conditions like retinal detachment, vitreous hemorrhage, and tumors, especially when direct visualization is hindered by cataracts or other media opacities. The following Contract Line-Items Number (CLIN) are being considered: Contract Line Items Manufacturer Part Number Description 0001 Lumibird PCBX0037SIS_G ABSolu S Ultrasound Platform Government Bundle ABSolu S Console, 2 Standardized A Probes, 2 Biometry A-Scan Probes, 2 B15 MHz Probes, 2 B20 MHz Probes, 2 50MHz UBM Probe, 2 Pocket III Pachymetry, Wireless Footswitch, ABSolu Cart, DICOM, Installation and Training 0002 Lumibird PCSX0011 Standardized A Probe for ABSolu - Spare 0003 Lumibird PCBX0037SUP Standardized A Probe for ABSolu (Includes Probe and ERM Board) for adding to an existing ABSolu Console (non S ) 0004 Lumibird PCSX0009 Biometry A-Scan Probe for ABSolu - Spare 0005 Lumibird PCSX0005 B 15 MHz Probe for ABSolu - Spare 0006 Lumibird PCBX0003 B 20 MHz B Probe for ABSolu - Spare 0007 Lumibird PCBX0056 B 20 MHz Probe for ABSolu (Includes Probe and ERM Board) for adding to an existing ABSolu Console 0008 Lumibird PCBX0007 50MHz UBM Linear Probe for ABSolu - Spare 0009 Lumibird PCBX0075 Pocket III Pachymeter for ABSolu Spare 0010 Lumibird PCBX0011AB_G Compact Touch II AB Government Bundle Compact Touch II AB Console, 2 Biometry A Probes, 2 B15 MHz Probes, 2 Pachymetry, Compact Touch II Cart, DICOM, Installation and Training 0011 Lumibird XEAX2PRBBIO Biometry A Probe for Compact Touch Spare 0012 Lumibird PCBX0025 B15 MHz Probe for Compact Touch - Spare 0013 Lumibird PCBX0023 Pachymetry for Compact Touch Spare 0014 Lumibird LUMIUMB_G LumiCare Umbrella Service Annual Renewal The Department of Veterans Affairs (VA) is seeking vendors who can provide Lumibird® Absolu and the Lumibird® Compact Touch II brand name or equal Scanning Systems Ultrasonic Ophthalmic AB Scan as listed above or equal commodities which meet all the following Salient Characteristics (SC): CLINs 0001 and 0010 apply to the following SCs. SC # SALIENT CHARACTERISTICS METHOD OF EVALUATION SC 1 Must be capable of A-Scan and B-Scan operations Literature Review SC 2 Must have capability to record, save and review a video of the examination Literature Review SC 4 Must have a foot switch control Literature Review SC 5 Dual-mode capability: Switch between or simultaneously use A-scan and B-scan Literature Review SC 6 High-frequency probes (typically 10 20 MHz): For detailed resolution Literature Review SC 7 User-friendly interface: Touchscreen or software-based controls Literature Review SC 8 A-Scan mode - Must be able to adjust the parameters for the biometry exam in A-scan for Eye type (Phakic / Dense Cataract/ Aphakic / PMMA / Acrylic / Silicone) and vitreous type (Vitreous Natural / Silicone 1000 (980m/s) / Silicone 5000 (1040 m/s)). Literature Review SC 9 A-Scan mode - One-dimensional: Displays spikes for different ocular structures (cornea, anterior lens, posterior lens, retina and tissue) Literature Review SC 10 A-Scan - Quantitative: Provides precise measurements for IOL (intraocular lens) power calculation. (i.e. Holladay, SRK-T, SRK 2, Binkhorst-II, Hoffer-Q, Haigis) Literature Review SC 11 B-Scan - Must provide a B-Scan two-dimensional cross-sectional image identifying tissue based upon reflectivity Literature Review SC 12 B-Scan Must be able to scan when media is opaque: E.g., dense cataracts, vitreous hemorrhage through opaque media including dense cataracts, vitreous hemorrhage and opaque cornea Literature Review SC 13 B-Scan Must allow surgeon to scan in different orientations (i.e. transverse, longitudinal, axial, and oblique views (Used for comprehensive evaluation)) Literature Review SC 14 Must allow for DICOM export or be DICOM compatible. Literature Review CLIN 0001 applies to the following SC.   SC #    SALIENT CHARACTERISTICS    METHOD OF EVALUATION  SC 3 Must allow surgeons to perform linear and anterior chamber angle measurements Literature Review  All CLINs apply to the following SC.   SC #    SALIENT CHARACTERISTICS    METHOD OF EVALUATION  SC 15 FDA 510K Approved Literature Review  For each product (brand name and part number), the response must include descriptive literature demonstrating the product meets or exceeds the salient characteristics specified above. The Government's intent is to include all ancillary items to ensure the equipment can function as designed by the Original Equipment Manufacturer (OEM) and as clinically required. Vendors are encouraged to provide any product solution or configuration so long as they meet the salient characteristics. Additionally, responses can include any additional product that may be beneficial. These items must be clearly identified by brand name and part number. Responses to this Sources Sought Notice shall include the following: Does vendor offer an annual service plan, Yes or No? If Yes: What does the plan cover? Does plan cover software updates only? Does the plan cover parts repair or replacement only? Does the plan cover both software and parts? Vendor are requested to provide documentation that shows information on their service plan. Is the service provided by the OEM or a subcontractor? Full name and address of company DUNS number/ CAGE Code/ SAM UIE Business Size Manufacturer or Distributor If distributor provide full name, business size and address of manufacturer. Country of Origin designation for all products Ability to provide uninterrupted supply of products on a national scale. Technical Literature that clearly shows product(s) meet the identified salient characteristics and page numbers where each salient characteristic is met. Any additional product solution or configuration that would be beneficial to the clinical functionality of the product line identified. Authorized Distributor Letter Certified by OEM with a current date. Although not required, vendors responding to this Sources Sought may also submit a Capabilities Statement.