COMBINED SYNOPSIS 36C10G25R0035_ NX EQ Ophthalmic Perimeters.pdf

SUBJECT* NX EQ Ophthalmic Perimeters (VA-25-00062935)

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE*

SOLICITATION NUMBER*

RESPONSE DATE/TIME/ZONE

ARCHIVE

RECOVERY ACT FUNDS

SET-ASIDE

PRODUCT SERVICE CODE*

NAICS CODE*

22408-2697 36C10G25R0035

06-03-2025 11:59PM EASTERN TIME, NEW YORK, USA

99 DAYS AFTER THE RESPONSE DATE

N

339112

CONTRACTING OFFICE ADDRESS U.S. Department of Veterans Affairs OPAL | Strategic Acquisition Center

10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697

POINT OF CONTACT* Contract Specialist Alex Beck Alex.Beck1@va.gov

PLACE OF PERFORMANCE

ADDRESS Nationwide

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov/opal/sac/index.asp

URL DESCRIPTION VA | OALC | OPAL | SAC

AGENCY CONTACT’S EMAIL ADDRESS Alex.Beck1@va.gov EMAIL DESCRIPTION Contract Specialist

DESCRIPTION

Solicitation Number:

36C10G25R0035

Notice Type:

Combined Synopsis/Solicitation Synopsis:

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for brand name or equal commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “-Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

Solicitation number 36C10G25R0035 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Proposal (RFP). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2025-03, dated 17 January 2025.

Requirement Description:

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has a requirement to purchase Ophthalmic Perimeters to deliver patient care at its VA Medical Centers around the country.

Ophthalmic Perimeters are electronic ophthalmic instruments designed to measure the quality and quantity of central and peripheral vision, which is the visual field. The device measures and records the visual field one eye at a time by projecting a light stimulus in a field that extends approximately 60-110 degrees, in all directions. Once the test is completed, the perimetry device converts the visual stimuli to a topography-like grayscale map that allows the ophthalmologist to see areas of normal vision, mildly depressed vision, and areas of severe depressed vision. These devices are used to diagnose and monitor diseases such as glaucoma and brain strokes.

A single award Requirements Contract will be awarded IAW FAR 52.211-6 Brand Name or Equal, accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Proposals shall contain the terms for cost/price and technical capabilities of the brand name or equal equipment. The Government reserves the right to award without discussions.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339112 – Surgical and Medical Instrument Manufacturing, Product Service Code: 6515 – Medical and Surgical Instruments, Equipment, and Supplies. The associated size standard is 800 employees.

Combined Synopsis/Solicitation Notice

This procurement action is issued as Unrestricted Full and Open.

This acquisition is for FAR Part 16.5 for Zeiss ® Brand Name or equal Ophthalmic Perimeters as identified in ATTACHMENT A – PRICE COST SCHEDULE - NX EQ Ophthalmic Perimeters.

All interested Offerors shall provide a proposal for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A – PRICE COST SCHEDULE – NX EQ Ophthalmic Perimeters.

The ordering period is for one 12-month base year with four 12-month option years. Delivery is FOB destination. Firm-Fixed Price Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities.

The FAR provision at 52.212-1, Instructions to Offerors – Commercial, applies to this acquisition including attached addenda to the provision.

The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also applies to this acquisition.

The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with its offer.

Clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached.

Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition. Addendum is attached.

All interested offerors must be registered in the System for Award Management (SAM) prior to submitting an offer. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 11:59 PM EST on May 27, 2025, to Contract Specialist, Alex Beck at Alex.Beck1@va.gov and Contracting Officer, Sara Vickroy at Sara.Vickroy@va.gov. No calls will be accepted.

Proposals are due via email by 11:59 PM EST on June 03, 2025, to Contract Specialist, Alex Beck at Alex.Beck1@va.gov and Contracting Officer, Sara Vickroy at Sara.Vickroy@va.gov.

https://sam.gov/SAM/ mailto:Alex.Beck1@va.gov mailto:Sara.Vickroy@va.gov mailto:Alex.Beck1@va.gov mailto:Sara.Vickroy@va.gov

1. SCOPE OF WORK

The Veterans Health Administration (VHA) Non-Expendable Equipment (NX) National Program has identified the Ophthalmic Perimeters product line as a candidate for a VA-wide (otherwise referred to as "national") single Requirements contract award.

Ophthalmic Perimeters are electronic ophthalmic instruments designed to measure the quality and quantity of central and peripheral vision, which is the visual field. The device measures and records the visual field one eye at a time by projecting a light stimulus in a field that extends approximately 60-110 degrees, in all directions. Once the test is completed, the perimetry device converts the visual stimuli to a topography-like grayscale map that allows the ophthalmologist to see areas of normal vision, mildly depressed vision, and areas of severe depressed vision. These devices are used to diagnose and monitor diseases such as glaucoma and brain strokes.

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Ophthalmic Perimeters to be used by clinicians throughout the VA medical centers and facilities located in the Continental United States (CONUS) or Outside of the Continental United States (OCONUS). The period of performance is for a base of 12-months with four 12-month option periods.

2. REQUIREMENT

This requirement will be IAW FAR clause 52.211-6, “Brand Name or Equal” which requires the offeror indicate that each product being offered as an “equal” product to the Zeiss Humphrey® Field Analyzer 3 (HFA3) Ophthalmic Perimeters. For each product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The offeror must also clearly identify the item by brand name (if any) and make/model number. Finally, the offeror must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer, and clearly describe any modifications it plans to make to a product to make it conform to the solicitation requirements.

The following line items comprise the Ophthalmic Perimeters product line:

Contract Line Items

Brand Part Number Description

0001 Zeiss MFA3 860 Humphrey Field Analyzer 3

0002 Zeiss Installation Installation

0003 Zeiss OPTIME Prevent

Service Agreement Preventative Maintenance and service hotline support

0004 Zeiss

OPTIME Advanced

Service Agreement Advanced Preventative and corrective maintenance with remote service (does not cover parts)

0005 Zeiss

OPTIME Complete

Service Agreement Complete Preventative maintenance, remote service, corrective maintenance and parts

0006 Zeiss Training Initial training

The Department of Veterans Affairs (VA) is seeking vendors who can provide Zeiss Humphrey®Field Analyzer 3 (HFA3) or equal Ophthalmic Perimeters identified above which meet all the Salient Characteristics (SC's). The Government intends for offerors to include all ancillary items, to ensure the equipment can function as designed by the OEM and as clinically required. Products offered in the technical volume must be captured on the Vendor’s pricing volume (Attachment A - Price Cost Schedule) of the solicitation.

Additionally, responses can include any additional product and other product-related services necessary to obtain the supplies as required that may be beneficial and essential to the functionality of the proposed solution. These items must be clearly identified by brand name and part number.

When offerors include their additional proposed product items/services, these items may be considered for evaluation, and must be captured in the vendor’s pricing volume with an estimated quantity of zero.

CLIN 0001 applies to the following SC’s

SC # SALIENT

CHARACTERISTICS

METHOD OF

EVALUATION

PAGE # WHERE THE SC IS LOCATED IN

TECHNICAL LITERATURE

SC 1 Must have testing range of at least 90 degrees

Literature Review

SC 2 Must have at least 3 Fixation Control options

SC 3 Must be capable of static perimetry testing

SC 4 Must be capable of kinetic perimetry testing

SC 5 Must perform multiple testing strategies/patterns/thresholds /modes

SC 6 Must provide perimetry progression/trend analysis results

SC 7 Must have ability to provide a minimum of these visual stimuli: white on white; red or blue on white; blue on yellow

SC 8 Must be DICOM compatible. Literature

SC 9 Must provide at least one year warranty

SC 10 Must integrate and function with both Vista/CPRS and Cerner

In addition to meeting the Salient Characteristics the following sub factors will be evaluated:

• Design Design features and functions of the offered device will be evaluated. Areas may include but are not limited to the following:

o Ability to integrate with VHA electronic health record o Ability to network with other devices o Size/footprint o Access to reports and images o Ability to interpret and analyze legacy data to create reports o User interface

• Performance

Device will be evaluated for its ability to perform its intended function. Areas may include but are not limited to:

o Fixation control options.

o Modalities to test the (central visual field) macula and the peripheral retina

(peripheral visual field) o Patient reliability evaluation/report/result o Algorithm for analysis o Patient identity verification o Offers various Testing Modalities that vary in time o Correction of refractive error o Remote real-time access to data o Progression analysis o Ability to generate combined reports correlating anatomic structure findings with visual function results in a single display/report o Format of Summary Results Report o Degrees of Visual Field-Testing Range o Visual Stimuli

• Quality Aspect of the construction and quality of material of the device will be evaluated and may include but not limited to:

o Life Expectancy o Warranty coverage and duration o Maintenance/service agreement o Installation and training

Vendors may offer any product solution or configuration so long as they meet the Salient Characteristics. Products offered in the technical volume must be captured on the Vendor’s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may offer any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor’s pricing volume with a quantity of zero.

INSTALLATION

The vendor/manufacturer will coordinate delivery and installation with the ordering VA facility POC. The Contractor will provide all travel, labor, parts, test equipment, tools, and incidentals necessary to perform all required installation

All Ophthalmic Perimeters shall be tested prior to acceptance. Equipment must meet manufacturer's performance and technical specifications, Federal Regulations, and VA Regulations. A written report shall be provided following each test. Acceptance shall not occur until device demonstrates compliance with the preceding conditions and performs as intended.

Testing shall be conducted by VA staff to include VA Biomedical personnel and OI&T. Testing shall insure and demonstrate that the equipment successfully integrates and functions with VA electronic health records in accordance with all Federal regulations and is capable of sending reports/data from the perimeter to the electronic health record, and the perimetry reports/data can be retrieved from the electronic health record.

TRAINING

The ordering facility and the vendor/manufacturer will schedule any offered training as established by CLIN. Training mode of delivery and training schedule will be purchased based on facility needs. The Contractor will provide their own travel and incidentals necessary to perform training at each ordering facility.

MAINTENANCE, REPAIRS AND REPLACEMENT

Preventative Maintenance will be performed as prescribed by the manufacturer’s specifications.

Maintenance, repairs, and replacement will be performed by authorized technicians and will be coordinated through the designated facility POC and Biomedical Engineer.

PRODUCT REFRESH

Product refresh is when a current CLIN is no longer being manufactured due to obsolescence and the product item is being replaced with a newer, and more often, a superior version of the same item. The current CLIN product will be revised to reflect the refreshed product information, manufacturer’s part number, IDC price (inclusive of Service Level Agreement (SLA) fee), etc.

The Government reserves the right to not accept the products offered under product refresh.

The contractor will be notified in writing if a product refresh is not accepted. All products offered shall be provided with the warranty that is agreed upon for this contract.

The contractor agrees to ensure that all upgraded improved/replaced products meet American with Disabilities Act (ADA) and Health Information Portability and Accountability Act (HIPAA) Federal requirements.

The contractor shall provide the COR and CO the following information for product refresh:

(1) A list of specific awarded item(s) being refreshed in the Price/Cost Schedule (to include commercial pricing, discount offered, and IDIQ price (inclusive of SLA fee));

(2) Product literature for the item(s) refreshed.

(3) A detailed description of the differences or benefits of refreshed as compared to the item(s) being discontinued or added.

(4) Proper identification of any product requirements and/or procedures related to those product(s) proposed to be refreshed or upgraded.

(5) FDA approval, if applicable

(6) Provide historical sales to VA by item(s), if applicable

(7) Copy of Commercial Warranty.

The request shall be submitted to the COR, copy to the Contract Specialist and Contract Officer, for review and recommendation of approval to be submitted to the CO. The CO shall prepare a bilateral modification for execution.

PRODUCT REMOVAL OR RECALL

For any product awarded under this contract removed or recalled by the manufacturer due to defects in the product or potential dangers to patients, or if any required removal or recall is suggested or mandated by a regulatory or official agency, the manufacturer shall resolve any defects or potential dangers by repairing or replacing the product at no cost to the government.

The manufacturer agrees to take following steps immediately:

Notify the Contracting Officer (CO) at the Strategic Acquisition Center in writing, by the most expeditious manner possible.

Provide copies of the notification to CO, Contracting Specialist, Contracting Officer Representative, and Manager at Product Recall Office, all Agencies and VA Facilities who purchased the product, which include, but not be limited to the following:

(1) Complete item description and/or identification, order numbers from customers and the contract number assigned as a result of an issuance on the solicitation;

(2) Reasons for modifications, removal or recall; and

(3) Necessary instructions for return for credit, replacement or corrective action.

A copy of the notification will be provided to: Manager, Product Recall Office

National Center for Patient Safety Veterans Health Administration

24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106

DATA RIGHTS

Commercial license agreements may be made a part of this Contract/Order but only if both parties expressly make them an addendum hereto, as permitted by FAR 12.212. If the commercial license agreement is not made an addendum, it shall not apply, govern, be a part of or have any effect whatsoever on the Contract/Order; this includes, but is not limited to, any agreement embedded in the computer software (clickwrap), any agreement that is otherwise delivered with or provided to the Government with the commercial computer software or documentation (shrink wrap), or any other license agreement otherwise referred to in any document. If a commercial license agreement is made an addendum, only those provisions addressing data rights regarding the Government’s use, duplication and disclosure of data (e.g., restricted computer software) are included and made a part of this Contract/Order, and only to the extent that those provisions are not duplicative or inconsistent with Federal law, Federal regulation, the incorporated FAR clauses and the provisions of this Contract/Order; those provisions in the commercial license agreement that do not address data rights regarding the Government’s use, duplication and disclosure of data shall not be included or made a part of the Contract/Order. Federal law and regulation including, without limitation, the Contract Disputes Act (41 U.S.C. § 7101 et seq.), the Anti-Deficiency Act (31 U.S.C. § 1341 et seq.), the Competition in Contracting Act (41 U.S.C. § 3301 et seq.), the Prompt Payment Act (31 U.S.C.

§ 3901 et seq.), Contracts for Data Processing or Maintenance (38 USC § 5725), and FAR clauses 52.212-4, 52.227-14, 52.227-19 shall supersede, control, and render ineffective any inconsistent, conflicting, or duplicative provision in any commercial license agreement. In the event of conflict between this clause and any provision in the Contract/Order or the commercial license agreement or elsewhere, the terms of this clause shall prevail. The Contractor shall deliver to the Government all data first produced under this Contract/Order with unlimited rights as defined by FAR 52.227-14. Claims of patent or copyright infringement brought against the Government as a party shall be defended by the U.S. Department of Justice (DOJ) in accordance with 28 U.S.C. § 516; at the discretion of DOJ, the Contractor may be allowed reasonable participation in the defense of the litigation. Any additional changes to the Contract/Order must be made by modification (Standard Form 30) and shall only be made by a warranted Contracting Officer. Nothing in this Contract/Order or any commercial license agreement shall be construed as a waiver of sovereign immunity.

System Updates

System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations. Examples include 52.222-25, Affirmative Action Compliance, and paragraph (d) of 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services. Contracting officers will not consider these representations when making award decisions or enforce requirements. Entities are not required to, nor are they able to, update their entity registration to remove these representations in SAM.

The following attachments are incorporated by reference. All criteria outlined in the attachments are applicable to this combined synopsis/solicitation.

See attached document: ATTACHMENT A - Price Cost Schedule -NX EQ Ophthalmic Perimeters

See attached document: ATTACHMENT B - Contract Administration - NX EQ Ophthalmic Perimeters

See attached document: ATTACHMENT C - Contract Clauses - NX EQ Ophthalmic Perimeters

See attached document: ATTACHMENT D - Solicitation Provisions - NX EQ Ophthalmic Perimeters

See attached document: ATTACHMENT E - Reporting Tool - NX EQ Ophthalmic Perimeters

See attached document: ATTACHMENT F - Past Performance Questionnaire - NX EQ Ophthalmic Perimeters

See attached document: ATTACHMENT G - Past Performance Reference - NX EQ Ophthalmic Perimeters