COMBINED SYNOPSIS SOLICITATION 36C10G24Q0126- NX EQ MICROSCOPE LIGHT OPERATING.pdf

Combined Synopsis/Solicitation Notice

*= Required Field Combined Synopsis/Solicitation Notice

SUBJECT* NX EQ MICROSCOPES LIGHT OPERATING

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 22408-2697

SOLICITATION NUMBER* 36C10G24Q0126

RESPONSE DATE/TIME/ZONE 09-04-2024 11:59 EASTERN TIME, NEW YORK, USA

ARCHIVE 45 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE

PRODUCT SERVICE CODE* 6515

NAICS CODE* 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 US

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov/opal/sac/index.asp URL DESCRIPTION To learn more about SAC and its mission, please click here

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

Solicitation Number: 36C10G24Q0126

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 (IAW) 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; quotes are being requested and a written solicitation will not be issued.

Solicitation number 36C10G24Q0126 is issued for this combined synopsis/solicitation;

this solicitation is being issued as a Request for Quote (RFQ). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal

Acquisition Circular (FAC) 2024-05, dated May 22, 2024.

Requirement Description:

Veterans Affairs (VA) has a requirement to purchase MICROSCOPES LIGHT

OPERATING to deliver patient care at its VA Medical Centers around the country.

MICROSCOPES LIGHT OPERATING uses visible light focused through a lens system to provide magnification (image amplification) and resolution of specimens under examination. It is one of the most basic components of a clinical laboratory and is used in virtually every department, including chemistry (for urinalysis), hematology, cytology, histology, and microbiology. In hematology, microscopic analysis of blood cells helps diagnose leukemias, anemias, and other blood disorders, as well as infections and allergies. In cytology and histology, microscopic examinations can detect abnormal changes in cells or tissues to differentiate benign, inflammatory, precancerous, or malignant conditions. Microscopic examination of urinary sediment is extremely valuable in laboratory evaluation of kidney function; the combination of a microscopic exam with a macroscopic exam (chemical evaluation) provides a complete urinalysis.

Selective staining techniques can also be used in microscopy to help identify parasites, fungi, and bacteria.

A single award Requirements contract will be awarded IAW FAR 52.211-6 Brand Name or Equal in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Quotes 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 – Optical Instrument and Lens Manufacturing, Product Service

Code: 6515 – Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 500 employees. This procurement action is issued as full and open competition.

This acquisition is for a single award Requirements contract in accordance with FAR

Part 16.5, Carl Zeiss Lumer 700® brand name or equal MICROSCOPES LIGHT

OPERATING and related equipment and accessories as identified in ATTACHMENT A

– NX EQ MICROSCOPES LIGHT OPERATING – PRICE COST SCHEDULE. All interested companies shall provide a quote for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A – NX EQ MICROSCOPES LIGHT OPERATING – PRICE

COST SCHEDULE.

The ordering period is for one 12-month base year with four 12-month option years.

Delivery is FOB destination 30 days ARO. 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 quoters must be registered in the System for Award Management (SAM) prior to submitting a quote. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 11:59PM EST on August 28, 2024, 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.

Quotes are due via email by 11:59PM EST on September 4, 2024, to Contract Specialist, at Alex Beck Alex.Beck1@va.gov and Contracting Officer, Sara Vickroy at Sara.Vickroy@va.gov.

1. BACKGROUND:

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the MICROSCOPES LIGHT OPERATING product line as a candidate for a VA-wide (otherwise referred to as “national”) single Requirement’s contract award.

The light microscope is an instrument for visualizing fine detail of a body part. It does this by creating a magnified image through the use of a series of glass lenses, which first focus a beam of light onto or through an object, and convex objective lenses to enlarge the image formed. They can be used to examine a wide variety of types of specimens, frequently with minimal preparation. Light microscopes can be adapted to examine specimens of any size, whole or sectioned, living or dead, wet or dry, hot or cold, and static or fast-moving. They offer a wide range of contrast techniques, providing information on the physical, chemical, and biological attributes of specimens.

The image from a light microscope is presented in color. It can be observed with the eye directly, recorded by photographic, video or computer techniques, and image components can be analyzed.

The Contractor must demonstrate the ability to meet all requirements for the solicitation.

The objective is to provide MICROSCOPES LIGHT OPERATING to be used by https://sam.gov/SAM/ mailto:Alex.Beck1@va.gov mailto:%20Sara.Vickroy@va.gov mailto:Alex.Beck1@va.gov mailto:%20Sara.Vickroy@va.gov mailto:%20Sara.Vickroy@va.gov clinicians throughout the VA medical centers and facilities. The period of performance is for one (1) 12-month base period 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 quoter indicate that each product being offered as an “equal” product to the Carl Zeiss Lumer 700® Microscope: Light, Operating. 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

Model

Part Number Description

0001 Zeiss

OPMI

LUMERA 700

Select

000000-2306- 382-

01PL7CYO

SELECT

(For a complete system order the following CLINS in addition to 0001: 0008-0021) Installation and training included

0002 Zeiss

OPMI

LUMERA 700

Anterior

000000-2306-

382-01PL7ANT

ANTERIOR

(For a complete system order the following CLINS in addition to 0002: 0008-0017, 0020- 0031) Installation and training included

0003 Zeiss

OPMI

LUMERA 700

Posterior

000000-2306-

382-01PL7POS

POSTERIOR

(For a complete system order the following CLINS in addition to 0003: 0008-0013, 0015- 0016, 0019-0022, 0025-0038) Installation and training included

0004 Zeiss

OPMI

LUMERA 700

OCT

000000-2306-

382-01PL7OCT

700 OCT

(For a complete system order the following CLINS in addition to 0004: 0008-0012, 0015- 0016, 0020-0021, 0023, 0025- 0028, 0030-0041) Installation and training included

0005 Zeiss Lumera 3D

4K ARTEVO

Anterior

000000-2314-

807-01PDIANT

ARTEVO ANTERIOR

(For a complete system order the following CLINS in addition to 0005: 0008-0011, 0013-

Contract Line

0018, 0020-0021, 0023-0024, 0028-0029, 0042) Installation and training included

0006 Zeiss Lumera 3D

4K ARTEVO

Posterior

000000-2314-

807-01PDIPOS

ARTEVO POSTERIOR

(For a complete system order the following CLINS in addition to 0006: 0008-0011, 0013, 0015-0016, 0020-0021, 0023, 0028-0029, 0031-0038, 0042 Installation and training included

0007 Zeiss Lumera 3D

4K ARTEVO

OCT

000000-2314-

807-01PDIOCT

ARTEVO OCT

(For a complete system order the following CLINS in addition to 0007: 0008-0011, 0015- 0016, 0020-0021, 0023, 0028, 0031-0038, 0040-0042 Installation and training included

0008 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-

10TILTMO Motorized Tilt

0009 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-

10SCIXEN Xenon Superlux Eye

0010 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-10FCPWLS Wireless Foot Control Panel

0011 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-

10FCPC3M 3m Cable for FCP

0012 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-

10OHDISP Overhead Display

0013 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-90O200MM Objective Lens f=200mm

0014 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-

90T180TS 180° Tiltable Tube

0015 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-

90EP10XM 10x eye pieces

0016 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-20ASIWEZ Assistant Scope w/ Elec. Zoom

0017 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-90T180TA 180° Tiltable Tube (assistant)

Line

0018 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-90EP10XA 10x eye pieces (assistant)

0019 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-30IKERAS Integrated Keratoscope Ring

0020 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-

60ACBSET Basic Asepsis Set

0021 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-

60CABSET Set of Cable Binders

0022 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-30IDISYS Int. Data Injection System

0023 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-30IKERAS Keratoscope for Cornea

0024 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-30ISLITI Integrated slit illumination

0025 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-40TEHD3C Int. 3-chip Full HD camera

0026 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-40USB1TB External Mini HDD USB 1TB

0027 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-50CEONFS CALLISTO eye on floor stand

0028 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-50CLICML License Refractive Assistance

0029 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-50CV371B CALLISTO eye P2, SW 3.7.1

0030 Zeiss

OPMI

LUMERA 700

System

000000-2306-

382-60TBL7SU

Transport box for Floor stand Single Use, without solid wood

0031 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-90EP10XA 10x eye pieces (assistant)

0032 Zeiss

OPMI

LUMERA 700

System

000000-2306-

382-30AL128D

128D aspheric wide-field lens

0033 Zeiss

OPMI

LUMERA 700

System

000000-2306-

382-30AL60DM

60D aspheric macular lens

Line

0034 Zeiss

OPMI

LUMERA 700

System

000000-2306-

382-30SCAYR

RESIGHT Metal Tray

0035 Zeiss

OPMI

LUMERA 700

System

000000-2306-

382-30RES700

RESIGHT 700 - Electric

0036 Zeiss

OPMI

LUMERA 700

System

000000-2306-

382-30SLH200

Sterile lens holder f=200mm

0037 Zeiss

OPMI

LUMERA 700

System

000000-2306-

382-90TINVEA

Invertertube E (assistant)

0038 Zeiss

OPMI

LUMERA 700

System

000000-2306-

382-90TINVES

Invertertube E

0039 Zeiss

OPMI

LUMERA 700

System

000000-2306-

382-30IDISSH

Int. Data Injection System w/S

0040 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-50CV371O CALLISTO eye P2 SW 3.7.1 w/OCT

0041 Zeiss

OPMI

LUMERA 700

System

000000-2306- 382-90O200RO Objective lens f=200mm for

OCT

0042 Zeiss

OPMI

LUMERA 700

System

000000-2314-

807-40GLAS3D

5x Stereo-Polarization Glasses

The Department of Veterans Affairs (VA) is seeking vendors who can provide Carl Zeiss Lumera 700® Microscope; Light, Operating, or equal as listed above which meet all the salient characteristics listed below: 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.

The following SC’s apply to CLIN’s 0001-0005

SC # SALIENT CHARACTERISITCS Method of Evaluation

SC 1

Must have a Motorized zoom system; zoom ratio of 1:6 (also written as 6:1) or greater

Literature Review

SC 2 Must have Integrated Retina Protection (Filter) Literature Review

SC 3

Magnification must be surgeon adjustable with either handgrip controls or foot-controlled pad (both is advantageous)

Literature Review

SC 4

Microscope Head (Optics) must have the capability to tilt (Motorized more advantageous)

Literature Review

SC 5 Must have a Wide-angle eyepiece of 10x Literature Review

SC 6 Must have Optics Focusing Range from 70mm

- 76mm Literature Review

SC 7 Main Light must be LED illumination (Xenon is advantageous) Literature Review

SC 8 Must have an integrated monitor (Display) of 22" or greater Literature Review

SC 9 Must have an OCT Imaging with wavelength between 800nm - 880nm Literature Review

SC 10 Must have an OCT Scan Depth between 2.5mm (or less) and 3.0mm (or greater) Literature Review

SC 11 Must have an OCT Axial Resolution of 2.4μm- 5.6μm in tissue Literature Review

SC 12

Must have an OCT Scan Range (Scan Length) adjustable up to 16mm or more. More adjustable is more advantageous

Literature Review

SC 13 Must have an Optics Rotation adjustable from 0-360 degrees (greater is advantageous) Literature Review

SC 14 Must have an Image Acquisition Scan Speed at or greater than 27,000 per second Literature Review

SC 15 Must have a Total Magnification with 10x eyepiece is 4.1x (or less) to 21x (or greater) Literature Review

SC 16

Must have Network connectivity and integration (Electronic Health Records/DICOM) Modality work-list capable (helps with Data Integrity)

Literature Review

SC 17 Must have an Integrated Assistant Scope with independent magnification Literature Review

SC 18 Must have a camera (3-Chip HD camera image sensor is advantageous) Literature Review

SC 19 Video Signal (Display Resolution) must be capable of 1080 Resolution Literature Review

SC 20 Must be capable of transferring video and images to other devices Literature Review

SC 21 Must have Touch Screen Controls Literature Review

SC 22

Must have Slit Widths range from 2mm or lower to 4mm or higher: minimum of 4 available settings or a continuous range

Literature Review

SC 23 Must have Objective Lens with Focal Length

(f) is between 175 and 200mm (or more) Literature Review

SC 24

Must be able to switch between wide-field or wide-view lens and a narrow-view or macular lens

Literature Review

SC 25 Must have IOL Placement Guide Literature Review

SC 26 Must have an XY Travel Range 60mm or greater Literature Review

SC 27 Must be Anterior and Posterior Surgery Capable Literature Review

SC 28 Must have Coaxial Illumination Literature Review SC 29 Must have Red Reflex Illumination Literature Review

SC 30 Must be capable of Fundus Viewing Literature Review

SC 31 Must be FDA Approved Literature Review

SC 32 Must come with a minimum of 1 Year warranty Literature Review

SOFTWARE INSTALLATION AND UPDATES

The Contractor grants to VA non-exclusive, non-transferrable licenses to use the OPMI LUMERA 700 System and all associated accessories and software, including any documentation, for the Systems intended purposes. At no additional cost, Customer will be entitled to Software updates when such updates are made generally available without cost to other licensees of the software. The Contractor shall coordinate the installation of any software upgrades with designated facility POC and Biomedical engineer.

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, IDIQ 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, see attachment 5.

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

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

MICROSCOPES LIGHT OPERATING.

See attached document: ATTACHMENT B - CONTRACT ADMINISTRATION - NX EQ

MICROSCOPES LIGHT OPERATING.

See attached document: ATTACHMENT C - CONTRACT CLAUSES - NX EQ

MICROSCOPES LIGHT OPERATING.

See attached document: ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ

MICROSCOPES LIGHT OPERATING.

See attached document: ATTACHMENT E - REPORTING TOOL - NX EQ MICROSCOPES

LIGHT OPERATING.

See attached document: ATTACHMENT F – PAST PERFORMANCE QUESTIONAIRE –

NX EQ MICROSCOPES LIGHT OPERATING

See attached document: ATTACHMENT G – PAST PERFORMANCE REFERENCE – NX

EQ MICROSCOPES LIGHT OPERATING