Brand Name Justification.pdf

VHAPM Part 813.106 Page 1 of 4 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: 36C242-21-AP-1060

1. Contracting Activity: Department of Veterans Affairs, VISN 02, James J. Peters VA Medical Center seeks to purchase brand Carl Zeiss Forum 4.x software Installation data management licensing system through 2237#526-21-1-3086-0036 on a competitive acquisition.

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

The proposed action is for approval to compete as a small business set-aside to award a firm-fixed price award contract for purchase of brand Carl Zeiss Meditec, Inc Forum 4.x software Installation and licensing. This data management system is for use with existing multiple pieces of medical equipment and local servers at James J. Peters VA Medical Center. The system will allow for analysis across Zeiss medical equipment as well as data back-up from Carl Zeiss field analyzers, Zeiss topographer, Zeiss HD-OCT’s, Zeiss Visucam Fundus camera and Zeiss FF450 Visupac Fundus camera. It will be used at the clinic in preformatted grouping for Glaucoma, Retina and cataract cases. The facility will have the capabilities to use system cameras all at once. The following technical specifications will meet the agency’s need:

Item#01F0BP42-Carl Zeiss Forum Basic License Package (v.4.2) Item#30GWP310-Carl Zeiss License Forum Glaucoma Workplace 3.0 user-Volume Pack 10X Item#30RWP310-License Carl Zeiss Retina Workplace User-Volume Pack 10X Item#40FCZDIC-Carl Zeiss Forum-Dicom Interface License to 3rd Party Dicom Instrument Item#40F3PDL3-Carl Zeiss Forum Interface License to CZM Instrument (VX. XX) Item#20ITLDSS-Carl Zeiss Hospital IT Integration LDAP/SSO Item#50FEMRH7-Forum-emr Package INCL.HL7 Item#266002-1131-909-PRO-Carl Zeiss Forum on-site Installation & Training Item#266002-1150-893-PRO-Carl Zeiss Enterprise Architecture Design (per hour) Item#266002-1130-065-Carl Zeiss PRO-Connectivity Service Plan, Annual Item#20FVW310-Carl Zeiss License Forum Viewer (V3)- Volume pack 10X Item#000000-2076-772-PRO-Carl Zeiss Upgrade Cirrus Instrument Review Software to Cirrus Carl Zeiss Review software 8.1 local database (includes RPE and GC Analysis) (10- Pack) with remote Installation Item#20GW31US-Carl Zeiss Glaucoma Workplace 3.1 https://www.acquisition.gov/?q=/browse/far/13

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The estimated amount for procurement: $140,657.16

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

James J. Peters VA Medical Center has multiple Carl Zeiss instruments that can be analyzed together with this Zeiss software only. Carl Zeiss Meditec, Inc, is the sole manufacturer of the Zeiss platform, no other organization offers Forum software. Current software at facility only allows analysis of a single machine at a time. This slows the process by taking care of patients at short intervals. New Carl Zeiss Forum software will alleviate that problem. The addition if this unique software will provide efficient longitudinal analysis.

Additional unique characteristics are as followed:

• Provides “Post Processing Analysis, Dynamic Review/Manipulation of RAW data” functionality for ZEISS Cirrus HD-OCT. If Glaucoma Workplace is procured, you can do with the ZEISS HFA Instruments as well.

• Ability to store and access raw instrument data from ZEISS Field Analyzer, ZEISS Cirrus HD-OCT, ZEISS Visucam Fundus Camera and ZEISS FF450/Visupac Fundus Camera systems.

• Functionality to enable real-time and dynamic editing/manipulation of all prior Visual Field Test data for all Glaucoma patients and allow for Baseline changes, real-time report generation for any VFI date, display Real Eye images and data from the new ZEISS HFA 3 instruments.

• Support for DICOM standards and Work-List functionality in order to create and send patient demographics to a specific or all instruments via a DICOM worklist within the eye clinic’s network.

• Combined Report: HFA-Cirrus reports for Structure Function analyses in Single

Display with OD-OS on one (1) page print out from data of Cirrus HD OCT and a Humphrey Visual Field. If Combined Report is procured as option.

• Image and Data Management System has Bi-directional DICOM capabilities to send both DICOM Modality Worklists containing Consult/Order details to instruments within the eye-clinics network and receive back the diagnostic test results and RAW data for storage within the Image and Data Management System for access.

• Device name and type, laterality and other key pieces of data with the least amount of user interaction. This must be then stored within the Image and

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Revision 02 Eff Date: 03/31/2020

Data Management System and forwarded to VISTA Imaging (Enterprise Clinical Imaging Archive)

• Image and Data Management System is able to download all past RAW data from one or more ZEISS Field Analyzers, ZEISS Cirrus HD-OCT’s, ZEISS Visucam Fundus Camera and ZEISS FF450/Visupac Fundus Cameras acquired within the main clinic and all satellite clinics upon installation of the Image and Data Management System.

• It can display ZEISS Field Analyzer Glaucoma Progression Analysis (GPA) and enable the clinician to manipulate data and store baseline changes at the workstation within the Image and Data Management System if Glaucoma Workplace is procured as a part of FORUM.

• It can display and allow the clinician to scroll through the various ZEISS Cirrus

Macula Cube B-scan slices, within in the Image and Data Management System viewer.

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

Market research was conducted, which included consulting with a representative of the Original Equipment Manufacturer (OEM), Carl Zeiss Meditec, Inc to find potential suppliers of the Zeiss Forum 4.x software Installation and licensing data management system.

The results of market research showed that through Veterans Information pages (VIP), it yielded 285 potential SDVOSB or VOSB vendors that can supply the software. A source sought posted on Contract Opportunities yielded two responses from two (2) SDVOSB vendors. A letter supplied by the Original Equipment Manufacturer (OEM) informed CO, that OEM does not sell direct to VA and so ordering would have to be done through authorized distributor/resellers. There is only two (2) authorized distributors of the Carl Zeiss software data system, Corps Biologics, LLC (SDVOSB) and Proaim America’s, LLC (Small business). A search in Small business dynamics (SBA), yielded zero (0) potential vendors that carry the software. A search on GSA E-library yielded zero (0) potential suppliers.

In summary, although there was two (2) SDVOSB responses, “rule of two” would not be considered because one of the SDVOSB vendors is not an authorized reseller/distributor of the software. There are only two authorized distributors that can supply this software. CO would recommend competing as a small business set-aside as the best interest to the Government for price fair and reasonable.

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.

https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466

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