36C24123P0285_1.docx

SUBJECT*

Cirrus HD-OCT 5000 Togus

GENERAL INFORMATION

BASE NOTICE TYPE

VAMC White River Junction 215 North Main Street White River Junction VT 05009-0001

POINT OF CONTACT*

Contracting Officer Deidra Thomas deidra.thomas@va.gov

AWARD INFORMATION

LINE ITEM NUMBER

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

Award Notice Award Notice

DESCRIPTION

*= Required Field Award Notice Award Notice

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C241-23-AP-1283

1. Contracting Activity: Department of Veterans Affairs, VISN 1, VAMC Togus MA.

PR: 402-23-2-100-0024

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

This is a new requirement for the Togus Eye Clinic, requesting the purchase of one Zeiss OS | Cirrus HD-OCT (Model 5000): with AngioPlex OCT Angiography. The Model 6000 remains on voluntary recall by Zeiss.

VAMC Togus is expanding Optometry Lane capabilities at VAMC Togus, located at 1 Veteran Center, Augusta, ME 04330-6719. The planned Optometry Lane Project will provide one State of the Art, Zeiss Cirrus-HD-OCT for the Eye Clinic department at Togus. The package will ensure full functionality of the Zeiss Cirrus-HD-Oct. The equipment allows for Comprehensive, clinically validated tools to diagnose and manage a range of conditions and seamlessly transfers raw patient data from previous generations of CIRRUS for continuity of patient care. The Cirrus 5000 is all about its speed and with increased speed comes greatly improved resolution and detail on cube, raster and OCTA scans, and the new faster Cirrus enables providers to incorporate these more reliable scans into their daily workflow and make important treatment decisions for patients.

The Optometry Lane Project requires the Zeiss Cirrus HD-OCT (Model 5000) with AngioPlex OCT Angiography Current Version W/ GCGPA, Smart HD Scans, FastTrac, Adv RPE, GCA, Ant Seg Basic, Printer & Table, item number 266002-1161-980-PRO has the capability to capture and provide OCT Angiography. The capability for the OCT Angiography is provided by a 1 single OCT scan that allows for visualization of both micro vascular and structural information in a noninvasive dye free scan by the OCT.

The Cirrus HD-OCT gives clinicians a larger field of view in a single scan and captures high-definition OCT/OCTA scans that reveal finer details of the retinal microvasculature − all of which provides more insight into the patient’s condition in less time. The system must have DICOM ability to interface with our software and must transmit the images to the patient records.

Original Estimate: $119,414.54

Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Optometry services and ophthalmological healthcare at VISN 1 VAMCs is being standardized to the Zeiss Optometry Line of products, specifically integrating and implementing Zeiss Cirrus OCT Systems. The standardization to Zeiss equipment aligns Optometry/ Ophthalmology treatment at VAMC Togus to the Optometry Lane innovations and upgrades occurring at other VAMCs across VISN1.

The Zeiss OS Cirrus HD-OCT (Model 5000) with AngioPlex OCT Angiography Version 11 is needed in order to provide proper testing and assessment, it is the only angiographic camera/diagnostic device that can provide the services we need. The VAMC Togus Optometry Clinic is standardizing all the VAMC and all CBOC (Community-Based Outpatient Clinic) locations to deliver exceptional eye exams and treatments. The Optometry staff is trained in similar Zeiss technology; the knowledge, training, and skills are easily transferrable to the Zeiss OCT 5000 technology, which facilitates implementation, ensures optimal efficiency, and which reduces the cost of switching to other equipment.

Zeiss OCT Series cameras integral to delivering a high standard of ocular/retinal care across VISN 1, across the VA, and in the private sector. The OCT has become the standard of care for retinal practices and other ocular conditions. The Zeiss OS Cirrus HD-OCT (Model 5000) with AngioPlex OCT Angiography Version 11 optimizes the quality of eye-care provided by the VAMC Togus Optometry Clinic with the Zeiss OS Cirrus OCT 5000 technology. The Zeiss OCT 5000 will allow the Togus Optometry Clinic to run more efficiently, while enhancing the current level and quality of care delivered.

The Zeiss Cirrus OCT contains advanced technology for ocular and retinal treatment that is peculiar to Zeiss. The Zeiss Cirrus HD-OCT-A technological features and salient characteristics for precision care and treatment of ocular and retinal issues, are proprietary to Zeiss. The OS Cirrus HD-OCT (Model 5000) with AngioPlex OCT Angiography Version 11 includes the following essential features:

· 3x3mm, 6x6mm, 8x8mm, 12x12mm (Retina); 4.5 x 4.5mm (Optic Nerve Head), 14x14mm, 14x10mm

· 35kg (77) lbs.)(without monitor)

· 100,000 A-scans per second

· 22’ Widescreen HD

· Wireless Keyboard and Mouse

· Windows 10

· Internal and External Fixation

· -20D to +20D (Diopters)

· Posterior Segment, Anterior Segment, OCT Angiography, and Fundus Imaging

· 12mm Raster; 3-12mm Cube

· OCTA: 3x3mm, 6x6mm, 8x8mm, 12x12mm (Retina), 4.5 x4.5mm (Optic Nerve Head), 14x14mm, and 14x10mm

· Instrument Weight: 35kg (77lbs)(Without Monitor)

· Instrument Dimensions (WxDxH): 62.2L x 42.5W x 29.2H cm (24.4L x 16.7W x 11.4H in.)

Processor: i7 Intel® Processor (7th Gen).

Per Brian Close, Government Sales Director at Carl Zeiss Meditec, Zeiss does not distribute directly to the Government. Zeiss distributes to the Government via two (2) Zeiss-Authorized Distributors: ProAim Americas LLC (SB) and Corps Biologics (SDVOSB). The peculiarity of the Zeiss technology required narrows the market and limits sourcing opportunities. Distribution is designated for Zeiss-Authorized distributors, only. Replacing the current Zeiss systems and technology would result in loss of skill and knowledge transference, reduce operational efficiency, and would increase cost of procurement and integration. This would also adversely impact quality of Optometry care, as introducing non-Zeiss brand equipment would reduce Optometry clinicians’ ability to manipulate captured images and would also impair system functionality.

3. Description of market research conducted and results or statement why it was not conducted:

Market research was extensive and conducted in the traditional manner, per FAR 10.001 and VAAR 810.001-70.

Market Research findings are as follows:

· VAAR 810.001-70 Compliance with VFCP (Veteran’s First Contracting Program): A VetBiz search was conducted using NAICS 334510 and the Keywords: OCT 5000 Camera. Five (5) SDVOSBs were located as being broadly capable for NAICS 334510, and the Keywords: Retinal Imaging. None are authorized to distribute for Zeiss.

· FAR 8.002-Mandatory Sources: The requested items are not available via any mandatory inventories, via Ability One, or FPI (Federal Prison Industries). The Zeiss OS Cirrus HD-OCT 5000 is not available via a mandatory SAC Contract.

· FAR 8.004-Non-Mandatory Contract Vehicles: The requested product is not available via GSA FSS or NAC (National Acquisition Center) contracts. Zeiss does hold a contract vehicle for MAS 333314, but this NAICS does not apply to the Zeiss OS Cirrus HD-OCT 5000.

· FAR 19.202-2 Preference for Small Businesses: SBA DSBS database was researched for NAICS 334510 and the Keyword: Ophthalmic. There were two (2) results. None are capable.

· Corps Biologics LLC (SDVOSB) is the primary OEM-Authorized distributor for the Zeiss

· ProAim (SB) is secondary.

· Both ProAim and Corp Biologics qualify as a nonmanufacturer via the SBA NMR Exception.

· VAAR 813.003-70(c) VFCP, Rule of Two, and Fair & Reasonable Offers:

· The Rule of Two (2) for VFCP class vendors cannot be met.

· There is only one (1) SDVOSB authorized to distribute for Zeiss.

· The SDVOSB primary distributor has declined the opportunity and referred the remaining distributor, a SB.

· NMR (Non-Manufacturing Rule) 13 CFR 121.406(b):

· There is an NMR Waiver for the NAICS/Keyword Combination: 334510 for all products within this NAICS classification.

· There is only one (1) SDVOSB authorized distributor; can only leverage a sole source set-aside IAW VAAR 819.7008.

· SDVOSB distributor declined opportunity and referred SB affiliate distributor, ProAim.

· The SB preference (FAR 19.202-2) can be leveraged as a Straight SB Set-Aside IAW FAR 19.5. ProAim is a SB.

· LOS (Limitations on Subcontracting) - 13 CFR 125.6: The requirement is expected to fall below SAT. LOS does not apply.

· FAR 19.5 Straight SB Set-Aside: The Decision Tree follows the SBA NMR Exception qualifying this procurement as a SDVOSB Set-Aside. The SDOSB declined the opportunity and referred the SB affiliate. A Straight SB Set-Aside cannot be directly leveraged, there is only one (1) Zeiss-Authorized SB distributor. Therefore only option to leverage a SB preference is to award to the remaining Zeiss-Authorized SB distributor. There is only one (1) capable source remaining.

· Recommended Strategy: The recommendation is for a sole source to the only viable and capable Zeiss-Authorized SB distributor: ProAim Americas LLC. Government distribution for the Zeiss OCT 5000 is only available via two (2) SB Class distributors: Corps Biologics LLC (SDVOSB) and ProAim Americas LLC (SB). Although the requirement qualifies for a SDVOSB set-aside, VFCP cannot be applied. The primary SDVOSB, Zeiss-Authorized distributor declined the opportunity based upon the warranty element for the OCT 5000. Corps Biologics LLC has relegated the opportunity to their Zeiss-Authorized SB affiliate, Pro-Aim Americas LLC.

4. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106-1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Contracting Specialist VAMC White River Junction VT VHAPM Part 813.106 Page 5 of 5 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020