P03 SSJ_Revised MPT-SAT- With OCT History_Cirrus OCT-09-11-21.pdf

VHAPM Part 813.106 Page 1 of 3 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

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: 36C241-21-AP-2634

1. Contracting Activity: Department of Veterans Affairs, VISN 1, 689 VA Connecticut Healthcare System, 2237 #

689-21-3-4201-0063.

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

VA Connecticut is expanding the New London CBOC (Community=Based Outpatient Clinic), located at 4 Shaws Cove #101, New London, CT 06320. The new space will contain an eye exam room. This room will need new equipment that is standardized to the existing equipment in the West Haven VA Medical Center. The new Cirrus OCT equipment will allow provision of ophthalmic care and treatment to more patients in the New London area.

Ophthalmological Treatment at VACT has been standardized to the Cirrus OCT Systems. The initial Cirrus 6000 OCT implementation took place in the Fall of 2020. In 2020, VISN 1 funded an eye PACs upgrade to Zeiss Forum. The transition to Zeiss Forum led to a loss of functionality that impacted patient care. The new implementation required a software upgrade that would enable OCT cameras due to integrate to the new Zeiss Forum. The Zeiss Cirrus OCT System replaced Heidelberg OCTs that did not properly integrate to Zeiss Forum.

This created additional work for physicians and fellows, requiring that they work between two different systems to effect patient care, and to ensure that the resulting image was properly transmitted to the PACs system.

PACS is a patients record system in CPRS. Mismatched data would cause issues patient images were reviewed for patient diagnosis and care decisions.

The Cirrus HD-OCT-A 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.

Estimate: $102,603.13.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used:

VACT (VA Connecticut) is seeking an additional Zeiss Cirrus OCT for the New London CBOC as the CBOC is already standardized to the existing Zeiss equipment VAMC West Haven. This ensures that users can migrate between campuses to receive a consistent standard of care. The Cirrus OCT System was originally purchased in 2020 and proven to be compatible with Zeiss existing equipment. The proposed Cirrus OCT System will best integrate with existing Zeiss equipment, and will afford a reliable and consistent interface with interconnected systems.

The Zeiss Cirrus OCT contains advanced technology for ocular and retinal treatment. The Zeiss Cirrus HD- OCT-A contains technological features and salient characteristics for precision care and treatment of ocular and retinal issues, that are proprietary and peculiar to the Zeiss brand. The OCT has become the standard of care for retinal practices and other ocular conditions at VACT. VACT receives 40,000 patient visits per year. Over 5,500 of these visits are at the retina clinic. The standard of care offered by the Zeiss Cirrus OCT is critical for the continued excellent level of care provided and this piece of equipment will allow the clinic to run more efficiently and maintain our current level and quantity of care delivered.

Historically, Zeiss has not distributed 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 required technology narrows the market and sourcing opportunities. Distribution is designated for Zeiss- Authorized distributors, only. The HD OCT-A machine must be compatible with the current eye clinic PACs system, Zeiss Forum. The system must have DICOM ability to interface with our software and must transmit the images to the patient records. We would lose the ability to manipulate images if another brand was selected, therefore, we need to acquire this specific piece of equipment to offer clinicians full functionality.

https://www.acquisition.gov/?q=/browse/far/13

VHAPM Part 813.106 Page 2 of 3

Revision 02 Eff Date: 03/31/2020

4. 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 the following guidance:

FAR 7.102, Acquisition Planning Policy FAR 10.001, Market Research Policy and VAAR 810.001-70 (Class Deviation) FAR 8.004 (a)(1) and VAAR 808.004-70 VAAR 813.003-70(c), Policy (Class Deviation) FAR 19.202-2, Locating Small Business Sources

Market Research: Market Research was conducted IAW (In Accordance With) FAR 10.001, FAR 8/VAAR

808.002 (Mandatory Sources) and VAAR 810.001-70 VFCP. The results of the market research conducted are listed below:

Vetbiz – VFCP (Veterans First Contracting Program): Searched NAICS code 334510 and keywords “Ophthalmic” on VetBiz Portal resulting in fourteen (14) matches. Only one (1) of the potentially capable SDVOSBs Corps Biologics LLC is authorized to distribute for Zeiss.

Mandatory Sources: Mandatory Sources were researched and were excluded:

➢ No VA agency or other agency has excess equipment of this nature.

➢ Neither AbilityOne or FPI (Federal Prison industries) can supply this product.

➢ There is no mandatory SAC (Strategic Acquisition Center) or NSSL (National Strategic Source

Listing) contract for this product or anything similar to the Cirrus 6000 OCT or the 5000 OCT product.

Non-Mandatory Sources: Per FAR 8: A search of GSA Advantage indicated that there are no SAC, NSSL, NAC, GSA, or SEWP contracts at current, that include the Zeiss Cirrus 6000 OCT 9.5 Version Camera and Software System, or the 5000 OCT System.

➢ Searched GSA Advantage website with keywords “Ophthalmic Camera” and “Cirrus 6000” with no results.

➢ Searched ECAT website with keywords “Cirrus 6000” resulting in 2 matches from PROAIM- Medical.

➢ FAR 8 Contractor Listings: A search of GSA e-Library indicated that there are no contractor listings under Cat 67-100 for Photographic Equipment - Cameras, Photographic Printers and Related Supplies & Services (Digital and Film-Based)

VetBiz: No Set-Aside Opportunities: Per VAAR 808.002 and VAAR 810.001-70, there were fourteen (14) VIP-Verified SD/VOSBs broadly capable for NAICS 335410 and the Keywords: Retinal Imaging. None of the vendors are authorized to distribute for the OEM. The only authorized SDVOSb distributor was not located on tis list but was verified separately as a bona fide SDVOSB.

NMR Class Waiver: There a NMR Class Waiver for NAICS 334510: Electromedical & Electrotherapy Apparatus Manufacturing.

➢ This NAICS was selected due to ocular and retinal diagnostics and imaging as main technological feature and objective of Cirrus OCT Camera.

➢ NAICS 339112 has a secondary Ophthalmic Instruments application, although many still reference this NAICS as the primary.

➢ NAICS 333316 applies in general but has a specification that it does not apply to video-type applications.

• The Cirrus OCT 6000 has a definite video and imaging objective.

Limitations on Subcontracting: 13 CFR 121.103:

➢ The request will fall below SAT. LOS does not apply.

Sole Source OEM: The Large Business OEM: Carl Zeiss Meditec, Inc., does not distribute directly to the

Government:

➢ The OEM has listed two (2) authorized Small Business Class distributors for the Zeiss Cirrus HD-OCT-

A:

➢ Sole Source Options: Per the SBA, we can award to SD/VOSB or Small Business as a sole source, IAW FAR 13.106-1(b)(1)(i), “Only One Capable Source.”

➢ The Government is directing a “Name Brand” requirement, procurement can be made to the Sole-

Authorized Zeiss distributor, for the Cirrus 6000 OCT specifically.

➢ There is a NMR Waiver for NAICS 334510; LOS doesn’t apply.

➢ Corps Biologics LLC is the only authorized SD/VOEB OEM Distributor for the Cirrus 6000OCT.

FAR 19.202-2: There is a NMR Waiver for NAICS 334510, which requires a SDVOSB Set-Aside if Rule of Two is met.

VAAR 819-202: SDVOSB Preference: There is a NMR Waiver for NAICS 334510. We cannot set-aside as there are not two (2) SDVOSB Authorized OEM distributors. Rule of Two (2) cannot be satisfied per VAAR 813.003-70(c) and 38 USC 8127(d). We can still leverage VFCP per VAAR 819.7007 with LSJ documentation for brand name.

VHAPM Part 813.106 Page 3 of 3

Revision 02 Eff Date: 03/31/2020

Strategy: Sole Source to Corps Biologics (SDVOSB) per FAR 13.106-1(b) for brand name, as the sole Zeiss Distributor for the Cirrus 5000 OCT. Leveraging VFCP via VAAR 819.7007. The Cirrus 5000 OCT is replacing the Cirrus 6000 OCT last minute due to voluntary recall.

5. 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.

Deidra Thomas Date Contracting Specialist

VAMC White River Junction VT https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466