Combined Synopsis/Solicitation Notice
Combined Synopsis/Solicitation Notice
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Combined Synopsis/Solicitation Notice
*= Required Field
Combined Synopsis/Solicitation Notice
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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 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, 0013-0018, 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)
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
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 2.4 m-5.6 m 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 REFRESHÂ Â
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.Â
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