6540--NON-CONTACT OPHTHALMIC BIOMETRY

Combined Synopsis/Solicitation for Commercial Items VHAPM Part 813.106-1/2 SAP: Soliciting Competition & Evaluation of Quotations/Offers Page 4 of 4 Original Date: 10/12/17 COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C24526Q0313 Posted Date: 2/24/2026 Original Response Date: 3/18/2026 Current Response Date: 3/18/2026 Product or Service Code: 6540 Set Aside : SDVOSB NAICS Code: 334510 Contracting Office Address LOUIS A JOHNSON VAMC 1 MED CENTER DR CLARKSBURG, WV 26301 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. This solicitation is a Request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-06 EFFECTIVE 10/01/2025. The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 with a small business size standard of 1250 employees. The NETWORK CONTRACTING OFFICE 5 is seeking to purchase a single non-contact ophthalmic biometry system with installation, training and warranty. All interested companies shall provide quotations for the following: Supplies Line Item Description Quantity Unit Price Total Price 0001 BRAND NAME OR EQUAL Argos Biometer 1 0002 Warranty, Installation and Training 1 Salient Characteristics: Perform accurate biometry, keratometry and intraocular calculations including toric lenses, especially in difficult cataract cases. Measurements must be obtained via non-contact. Measurements obtained via two-dimensional swept-source OCT (SS-OCT). Must have ability to obtain biometry readings on dense cataracts. Automated data transfer: Must be capable of seamlessly integrating with ophthalmic data management systems already in place to eliminate manual data entry errors. The data management system in place is the ZEISS FORUM. Must be capable of transferring data via ZEISS FORUM into the biometry unit and vice versa. DICOM compatibility: Must be DICOM-compliant to interface with electronic medical record systems i.e. VISTA. Physical and Operational Requirements Must have a compact and ergonomical design. Must include patient positioning features. Adjustable chin rest. Head support for stable measurements. Must be compatible with standard U.S. electrical outlets. Must be FDA-approved for use in ophthalmic biometry and comply with ISO standards for medical devices. Statement of Work 1.0 General 1.1 Background The mission of the Hershel Woody Williams VAMC is to provide patient care. The mission of the Optometry Service is to provide assessment, diagnosis, and treatment of vision care. This acquisition will be an additional piece of equipment that will take more accurate measurements used for cataract implants. 1.2 Objective Due to increased volume of cataract cases being performed, this acquisition will speed up the time spent doing manual A-scans, as well as give a more accurate measurement with the advanced technology the Argos will provide. 1.3 Scope of Work The Argos will replace having to do manual A-Scans. Must perform accurate biometry, keratometry and intraocular calculations including toric lenses, especially in difficult cataract cases. Measurements should be obtained via two-dimensional swept-source OCT (SS-OCT). Must obtain non-contact measurements. Must be able to dicom images into Vista Imaging and Zeiss FORUM. 1.4 Period of Performance N/A 1.5 Place of Performance The place of performance is the Eye Clinic, located on the third floor west of the Hershel Woody Williams VAMC. 1.6 Applicable Documents N/A 2.0 Specific Requirements/Tasks 2.1 Installation 3.0 Delivery or Deliverables The contractor will coordinate with the Veterans Affairs Medical Center department of biomedical engineering, to service all on-site installation of hardware and software, as well as to provide any on-going support within the frame of their warranty-period. The warranty contract shall be pursued and maintained by the department of biomedical engineering. 4.0 Meetings N/A 5.0 Required Travel and Other Direct Costs (ODCs) No travel will be required. 6.0 Government Furnished Property/Equipment/Information This device will be installed and used on existing property of the Hershel Woody Williams VAMC. 7.0 Special Instructions The C&A requirements do not apply, and that a Security Accreditation Package is not required 8.0 Glossary of Abbreviations and Acronyms N/A 9.0 Records Management Addendum RECORDS MANAGEMENT OBLIGATIONS A.  Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.  B.  Definitions Federal record as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.  The term Federal record: includes [Agency] records. does not include personal materials. applies to records created, received, or maintained by Contractors pursuant to their [Agency] contract. may include deliverables and documentation associated with deliverables. C.  Requirements 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. [Agency] 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 [Agency] 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 [Agency]. 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 [Agency] 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 [Agency] 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 [Agency] policy. The Contractor shall not create or maintain any records containing any non-public [Agency] 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 [Agency] 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 [Agency] 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 [Agency]-provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training. [Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.] D.  Flowdown of requirements to subcontractors The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor. Place of Performance Address: Hershel Woody Williams VAMC 1540 Spring Valley Dr. Huntington, WV Postal Code: 25704 Country: UNITED STATES Award shall be made to the quoter whose quotation offers the best value to the government, considering technical capability i.e. salient characteristics of offered product, past performance, and price. The government will evaluate information based on the following evaluation criteria: "(1) technical capability factor "meeting or exceeding the requirement i.e. salient characteristics, (2) past performance, and (3) price.  Technical and past performance, when combined, are approximately equal to cost or price. The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Items SEPT 2023 FAR 52.212-3, Offerors Representations and Certifications Commercial Items OCT 2025 Offerors must complete annual representations and certifications on-line at http://orca.bpn.gov in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: FAR 52.212-4, Contract Terms and Conditions Commercial Items NOV 2023 Addendum to 52.212-4 are as follows: 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): https://www.acquisition.gov/browse/index/far https://www.va.gov/oal/library/vaar/ FAR Number Title Date 52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS NOV 2023 52.204-9 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL JAN 2011 52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018 52.225-1 BUY AMERICAN - SUPPLIES OCT 2022 852.203-70 COMMERCIAL ADVERTISING MAY 2018 852.204-70 PERSONAL IDENTITY VERIFICATION OF CONTRACTOR PERSONNEL MAY 2020 852.211-70 EQUIPMENT OPERATION AND MAINTENANCE MANUALS NOV 2018 852.246-71 REJECTED GOODS OCT 2018 VAAR 852.211-72 TECHNICAL INDUSTRY STANDARDS (NOV 2018) (a) The Contractor shall conform to the standards established by: FDA as to 510K compliance . (b) The Contractor shall submit proof of conformance to the standard. This proof may be a label or seal affixed to the equipment or supplies, warranting that the item(s) have been tested in accordance with the standards and meet the contract requirement. Proof may also be furnished by the organization listed above certifying that the item(s) furnished have been tested in accordance with and conform to the specified standards. (c) Offerors may obtain the standards cited in this provision by submitting a request, including the solicitation number, title and number of the publication to: https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k. (d) The offeror shall contact the Contracting Officer if response is not received within two weeks of the request. (End of Clause) VAAR 852.219-73 VA NOTICE OF TOTAL SET-ASIDE FOR CERTIFIED SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESSES (JAN 2023) (DEVIATION) (a) Definition. for the Department of Veterans Affairs, Service-disabled Veteran-owned small business concern or SDVOSB : (1) Means a small business concern (i) Not less than 51 percent of which is owned by one or more service-disabled Veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled Veterans or eligible surviving spouses (see VAAR 802.201, Surviving Spouse definition); (ii) The management and daily business operations of which are controlled by one or more service-disabled Veterans (or eligible surviving spouses) or, in the case of a service-disabled Veteran with permanent and severe disability, the spouse or permanent caregiver of such Veteran; (iii) The business meets Federal small business size standards for the applicable North American Industry Classification System (NAICS) code identified in the solicitation document; (iv) The business has been certified for ownership and control pursuant to 38 U.S.C. 8127, 13 CFR 128, and is listed as certified in the SBA certification database at https://veterans.certify.sba.gov/; and (v) The business agrees to comply with VAAR subpart 819.70 and Small Business Administration (SBA) regulations regarding small business size, government contracting, and the Veteran Small Business Certification Program at 13 CFR parts 121, 125, and 128. (2) The term Service-disabled Veteran means a Veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16). (3) The term small business concern has the meaning given that term under section 3 of the Small Business Act (15 U.S.C. 632). (4) The term small business concern owned and controlled by Veterans with service-connected disabilities has the meaning given the term small business concern owned and controlled by service-disabled veterans under section 3(q)(2) of the Small Business Act (15 U.S.C. 632(q)(2)). (5) The term SDVOSB participant or certified SDVOSB means a small business that has been certified in the SBA Veteran Small Business Certification Program and listed in the SBA certification database (see 13 CFR 128.102). (b) General. In order for a concern to submit an offer and be eligible for the award of an SDVOSB set-aside or sole source contract, the concern must qualify as a small business concern under the size standard corresponding to the NAICS code assigned to the contract and be listed as an SDVOSB participant in the SBA certification database as set forth in 13 CFR 128. (1) Offers received from entities that are not certified SDVOSBs and listed in the SBA certification database at the time of offer shall not be considered. (2) Any award resulting from this solicitation shall be made to a certified SDVOSB listed in the SBA certification database who is eligible at the time of submission of offer(s) and at the time of award. (3) The requirements in this clause apply to any contract, order or subcontract where the firm receives a benefit or preference from its designation as an SDVOSB, including set-asides, sole source awards, and evaluation preferences. (c) Representation. Pursuant to 38 U.S.C. 8127(e), only certified SDVOSBs listed in the SBA certification database are considered eligible to receive award of a resulting contract. By submitting an offer, the prospective contractor represents that it is an eligible and certified SDVOSB as defined in this clause, 13 CFR 121, 125, and 128, and VAAR subpart 819.70. (d) Agreement/LOS certification. When awarded a contract action, including orders under multipleaward contracts, an SDVOSB agrees that in the performance of the contract, the SDVOSB shall comply with requirements in VAAR subpart 819.70 and SBA regulations on small business size, and government contracting programs at 13 CFR part 121 and part 125, including the non-manufacturer rule and limitations on subcontracting (LOS) requirements in 13 CFR 121.406(b) and 13 CFR 125.6. For the purpose of limitations on subcontracting, only certified SDVOSBs listed in the SBA certification database (including independent contractors) shall be considered eligible and/or similarly situated (i.e., a firm that has the same small business program status as the prime contractor). An otherwise eligible firm further agrees to comply with the required LOS certification requirements in this solicitation (see 852.219 75 or 852.219 76 as applicable). These requirements are summarized as…