SSJ FAR Part 13 -under 250k - Visual Field machines Signed 1R_Redacted.pdf

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: 36C244‐20‐AP‐2297

1. Contracting Activity: Department of Veterans Affairs, James E. Van Zandt Medical Center, 2907 Pleasant Valley Blvd, Altoona, Pa 16602.

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

This is a New Brand Name Requirement for six (6) Zeiss Visual Field Machines (VFI) that are used to test for Glaucoma. The James E. Van Zandt Medical Center is expanding the Optometry Department to each CBOC. The Guided Progression Analysis™ (GPA) is the only visual field analysis that includes both event‐based and trend‐based analysis. It assesses patient’s compliance with RelEYE technology in both GPA and single‐field analysis modes.

This provides greater efficiency and streamlined workflow creating positive patient outcomes. The Normative data for Swedish Interactive Threshold Algorithm (SITA) Standard is for patients with intracranial tumors and SITA Fast for 30‐2, 24‐2 and 10‐2 threshold visual field test results is for healthy subjects, ages 17 to 89. Zeiss has a Central archive storage, combined reporting, and seamless integration with electronic medical records (EMR’s). By having One Central Patient Database the clinic could continue with the GPA (Guided Progression Analysis) regardless of which unit the patient is tested on. This dramatically reduces test time without sacrificing accuracy, achieves the fastest possible test with less fatigue, and is designed to deliver reliable results. The Zeiss Glaucoma Workplace can have all current Humphrey visual Field Analyzer (HFA) Visual Fields from Zeiss, along with the new HFA being requested, into one central database. This would allow the account greater efficiency in having patients being tested on any all current and new units and act as one central patient database.

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

The unique features that make the Zeiss Visual Field Machines unique and limit to only one source that can be used are listed below:

• Zeiss has the ONLY Approved Medical Device for VISTA Imaging.

• ZEISS HFA3 is the only Model that thru FORUM can integrate with the Zeiss Cirrus OCT that combines both modalities (HFA3 and OCT Cirrus) on to a 1 page report called "Combine Report" showing both "Structure and Function" analysis of a Glaucoma Patient.

• Only Zeiss HFA is a Class 2 Medical Device. This is due to having the GPA, (Guided Progression Analysis. All other units provide a "Trend Analysis". Since Zeiss states Progression this had to be cleared the FDA.

• Uniquely trended VFI in our GPA analysis. VFI is designed and has at least one publication that shows it reduces the effect from cataract compared to MD.

• Only Zeiss HFA3 can accept (down to exact algorithmic level and testing) data from all HFA2 and HFA2i data, which key requirement to continue "Progression Analysis".

• Only HFA3 test results can be directly compared and is interchangeable with all HFA2 and HFA2i data, which is a key requirement given all current Visual Fields in the Clinic are the HFA from Zeiss.

• Only Zeiss can accept all data from HFA's and continue to use in the "GPA", Glaucoma Progression Analysis.

• Unique patented algorithm utilized in the majority of case studies by universities and drug manufacturers.

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

After reviewing GSA, VIP, and NAC there are SDVOSB’s and VOSB’s, or small businesses authorized to distribute Zeiss equipment. RFI # 36C24420Q0628 shown two (2) SDVOSB’s capable to provide ZEISS HFA3 860 Equipment. The Zeiss equipment will be procured according to Far 13 Open Market procedures as an SDVOSB Set‐Aside.

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.