6515--NX EQ Scanning Systems: Laser: Optical Biometry (VA-26-00026659)

REQUEST FOR INFORMATION

1. DESCRIPTION

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Scanning Systems: Laser: Optical Biometry 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) Strategic Acquisition Center (SAC) 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 SAC in conjunction with VHA is seeking a qualified source to provide 3M® brand name or equal the Scanning Systems: Laser: Optical Biometry 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: Laser: Optical Biometry 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 objective is to provide Scanning Systems: Laser: Optical Biometry to be used by clinicians throughout the VA medical centers and facilities. The period of performance is

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

SCOPE OF WORK:

A Scanning Systems: Laser: Optical Biometry is crucial for accurate IOL power calculations before cataract surgery, ensuring optimal vision after the procedure. It involves measuring the eye's anatomical characteristics, like axial length and corneal curvature, to determine the correct IOL power needed to achieve the desired refractive outcome.

Scanning Systems: Laser: Optical Biometry is used as part of a cataract surgery procedure. Cataract is the name given to the human lens that lives behind the iris when it becomes cloudy. The human eye has the ability to see or not see based on three things.

a. The axial length of the eye.

b. The power of the lens.

c. The power of the clear surface of the eye (cornea).

The lens has magnification power just like the surface of the eye (cornea). If a surgeon removes the human lens, it must be replaced with equivalent power so that all three factors add up to enough power for the eye to see. As an example, 60 diopters at a distance, and 62 diopters to see up close. The biometry device measures the power of the cornea around (40 diopters), measures the power of the lens (around 20 diopters) and then uses the length of the eye (distance between the cornea and the lens and distance of the cornea to the retina). One simple formula is called the SRK/T. The biometry device predicts the power of what the lens power should be to make the patient see clear at a distance or near.

The biometry device also predicts what the power of the artificial lens, called intraocular lens implant (IOL), should be if placed in different parts of the eye (in front of the iris or behind the iris). If emplaced behind the iris, it is about 20 diopters and if emplaced in front of iris, it is about 17 diopters. In other words, the Scanning Systems: Laser: Optical Biometry is the most important diagnostic device to perform cataract surgeries. Without this system, facilities are unable to perform cataract surgeries. The device performs procedures for Current Procedural Terminology (CPT) 76514, 76512, 99174, 92025, and 92136. The surgery CPT codes are 66984, 66982, 66991, and 66989. Within the VA, approximately 70K surgeries are performed annually.

2. REQUIREMENT

This requirement will be IAW FAR clause 52.211-6, Brand Name or Equal which requires the quoter indicate that each product being offered as an equal product to the Zeiss® IOL Master 700. For each equal product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The quoter must also clearly identify the item by brand name (if any) and make/model number. Finally, the quoter 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.

Contract Line Items

Manufacture

Part Number

Description

0001

Zeiss

266002-2118-007

IOL Master 700

0002

Zeiss

000000-2244-886-40FCZDIC

Forum-DICOM Interface

The Department of Veterans Affairs (VA) is seeking vendors who can provide Zeiss® IOL Master 700 or equal as listed above which meet all the following salient characteristics: Vendors may quote any product solution or configuration so long as they meet the salient characteristics. Products quoted in the technical volume must be captured on the Vendor s pricing volume (Attachment A, Price Cost Schedule) of the solicitation. Vendors may quote 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.

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

Applicable CLIN

SC Literature Map

SC 1

Must have ability to obtain biometry readings on dense cataracts

Manufacturer Meeting, Literature Review

0001

SC 2

Must have at least 3 biometry formulas (Barrett, Holladay, Hoffer, Haigis)

Manufacturer Meeting, Literature Review

0001

SC 3

Must be capable of providing the surgeon with multiple Intraocular Lens Power options (anterior chamber, posterior chamber (bag), Sulcus

Manufacturer Meeting

0001

SC 4

Must perform keratometry measurements

Manufacturer Meeting, Literature Review

0001

SC 5

Must provide calculations for Toric Lenses

Manufacturer Meeting, Literature Review

0001

SC 6

Must have ability to compensate for motion artifact (patient moving)

Manufacturer Meeting, Literature Review

0001

SC 7

Must be DICOM compatible

Manufacturer Meeting, Literature Review

0001, 0002

SC 8

Must provide at least one year warranty

Manufacturer Meeting

0001

SC 9

Must integrate and function with both Vista/CPRS and Cerner

Manufacturer Meeting

0001

SC 10

Must have ability to connect and function with an operating room Microscope

Manufacturer Meeting

0001

SC 11

Must have ability to perform corneal topography

Literature Review, Manufacturer Meeting

0001

SC 12

Must have ability to compensate for previous refractive surgeries (RK, PRK, LASIK) when providing an IOL power calculation

Manufacturer Meeting, Literature Review

0001

SC 13

Must have FDA 510 K approval

Literature Review

0001

In addition to meeting or exceeding the minimum salient characteristics listed on Combined Synopsis/Solicitation Notice, the Government will evaluate the following specific technical areas and assign an adjectival rating:

Design (All design features and functions of the offered device will be evaluated. Areas may include but are not limited to the following)

Types of devices that the biometry will communicate/interface with

Ability to send and retrieve reports to and from CPRS and Cerner

Ability to use previously stored data to compare results over time

User interface features and ease of use

Performance

Quantity and quality of fixation controls (compensate for patient motion)

Modalities (methods) to calculate Intraocular lens power (light, ultrasound, LASER)

Types and duration of testing modalities

Ability to determine refractive error

Ability to provide remote access to data/reports and images, other than at the device itself, immediately upon completion of the test.

Support

Warranty terms and conditions

Service plan terms and conditions

Again, 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.