Attachment D.2 - Brand Name Justification.pdf

Effective Date: 02/01/2022 Page 1 of 4

Acquisition Plan Action ID:

Requisition Number:

1. Contracting Activity:

Department of Veterans Affairs (VA), Network Contracting Office 16 (NCO 16) located at 5075 Westheimer Road, Suite 750, Houston, TX 77056.

2. Nature and/or Description of the Action Being Processed

The Southeast Louisiana Veterans Health Care System (SLVHCS) Ophthalmology Surgical Program, 2400 Canal St, New Orleans, LA 70119 is seeking purchase a brand name VuPad Ultrasound system and associated accessories.

VuPad Ultrasound is an ophthalmology medical device that detects eye deformities such as cataracts, pseudophakia, and detected retina. The medical device allows the surgeon to superimpose an A-scan trace onto B-scan and UBM for precise measurement and analysis reducing for error and eye injury. The medical device eye tracking alignment provides real-time images to ensure proper alignment for sulcus-sulcus measurements, including mydriatic and miotic conditions.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

SLVHCS is requesting a brand name only VuPad Ultrasound system and associated accessories. The purchase of the new VuPad Ultrasound system will be placing broken equipment that was purchased in 2016. The system is needed for continuity of care to support the existing Standard Operating Procedure (SOP) and eliminate the process of creating new Instructions for Use. Also, it would eliminate the need to create a new competency for the employees to get certified to operate the equipment. The need to use a different brand and model would take man hours in training on a new brand and model. Due to it all-inclusive design, the medical device that provides an all-in-one diagnostic approach that collective allows for precise reading, measurements, and imaging reduces injury and errors. There are other similar devices on the market; however, there they do not provide the all-inclusive and connectivity as the VuPad Ultrasound. To obtain similar outcomes, the medical center would have to purchase 3 medical devices, which the clinical engineering team would have to somehow attempt to coordinator the communication between the devices and the medical center’s electronic health records. Furthermore, this medical device is used in the operation room – high risk area. Eliminating the multiple devices and anesthesia sedation time is imperative to the suggest of the veterans recover.

Effective Date: 02/01/2022 Page 2 of 4

VuPad Ultrasound system and associated accessories should include:

VuPad B-Scan / UBM / A-Scan / Pachymeter System BUAP.580 US.IM 5575-1403-4, VuPad Unit A101, 2.0kV Standard A-Probe, 10 MHz A120-2, Straight Pachymeter Probe for PacScan Plus, 20 MHz B101-9, 12 MHz B-Probe B101-5, Water Path Probe B101-6, 35 MHz Transducer SH106, Multi-Probe Cable SH124-1, USB Foot Pedal PS01-0010-44, VuPad Medical-Grade Power Supply; 12V 2.5A CA20-1802-42, 2 Prong, 60Hz USA Mains Power Cord 5575-1901-1, VuPad User Manual A118-3KIT, Immersion Cups (Set of 4 - 18/20/22/Silicone) MC10-1809-09, Windows 10 IoT Enterprise 2021 LTSC

U21, Sonomed Escalon Ultrasound DICOM Module

Statutory Authority Permitting Restricted Competition:

implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement . Competition is restricted on this procurement for the reason below:

Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The SLVHCS Ophthalmology Surgical program needs the VuPad Ultrasound system for continuity of care, seamless implementation thus reducing the amount of startup time, training, and elimination of human errors. Furthermore, the system will support the immediate need the ongoing operations and workflow of the department. Due to these facts, brand name only VuPad Ultrasound system is required. If name brand only was not used for this portion of the requirement, Veteran health would be impacted due to delays of training employees to get certified to operate the equipment. The need to use a different brand and model which would affect patient safety because the patient would experience an extended time under anesthesia sedation