Brand Name Justification (Heart Lung)_Redacted.pdf

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6515--(635) OKC VA - LivaNova Sorin S5 Perfusion Machine Replacement (VA-23-00086279)
Solicitation number
36C25923Q0928
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This document is a brand name justification for the Department of Veterans Affairs to purchase a LivaNova Sorin S5 heart-lung machine from LivaNova as a sole source procurement. The Oklahoma City VA Healthcare System requires a second identical heart-lung machine to use as a backup in case of malfunctions during cardiac surgeries, in order to allow surgeons, nurses and perfusionists to seamlessly transition between machines without risk to patients. LivaNova accessories are also specified for full compatibility with the machine software and network configuration already in use at the facility. Market research found no other authorized distributors for the equipment besides Veterans Healthcare Supply Solutions. The justification meets FAR requirements for a sole source procurement under $250,000.

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VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting for Brand Name Attachment 1: Brand Name Justification for SAP under the SAT

Last Updated: 02/01/22 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

Justification for Brand Name IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: Tracking #

1. Contracting Activity: Ordering Activity:

Department of Veterans Affairs Department of Veterans Affairs Network Contracting Office 19 Oklahoma City VAMC 6162 S Willow Dr. Suite 300 921 N.E. 13th St Greenwood Village, CO 80111 Oklahoma City, OK 73104

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

The Oklahoma City VA Healthcare System (OKC VAHS), Surgery Service, is requesting to purchase a LivaNova Sorin S5 Heart-Lung Machine. This machine is required for perfusion services during cardiac surgeries. The S5 system is used to perform, control and monitor extracorporeal blood circulation during cardiopulmonary bypass procedures lasting six hours or less.

This requirement shall be awarded as a new contract. The contract shall be awarded as a Supply contract through NCO 19’s Supply 1 team.

Product Description MODEL Quantity Unit (S5) 4-Pump Console w/ Power Supply SOR 48-40-00Z 1 each Cable holding and organizing system SOR 45-09-11 1 each Ops Manual S5 SOR 45-95-14USA 1 each Tubing Gate SOR 10-81-30 4 each Sechrist Blender Oxygen Hose Assembly SOR 050350200 1 each Cable holding and organizing system SOR 45-09-10 1 each Cap for fast clamp (6 pcs) SOR 43-42-61 1 each 4-Slot System Panel SOR 28-95-00 1 each (S5) Display Module SOR 28-95-10Z 4 each S5 Cardioplegia Sensor Module SOR 27-80-20Z 1 each (S5) Temperature Sensor Module SOR 20-30-20Z 1 each (S5) Pressure Sensor Module (2-Channel) SOR 22-20-20Z 1 each SRD S5 Level Sensor Module SOR 23-41-00 1 each (S5) Single Roller Pump SOR 10-80-00Z 4 each Color Code Set SOR 50-80-99 1 each CP5 SOR 60-00-60Z 1 each Operator Manual for the CP5 SOR 45-90-75USA 1 each Tray for 2 Roller Pumps SOR 10-84-64 2 each (S5) 3/8" Bubble Sensor Module w/ 420 mm SOR 23-45-00Z 1 each

Last Updated: 02/01/22 Page 2 of 3

Tubing Insert, Metal, 3/8 x 3/32, Blue SOR 10-07-48 1 case Crosstray 4 Position w/ Power Outlet SOR 48-41-19 1 each PAS Sechrist 3500 CP-G SOR 050350000 1 each Sechrist IV308 Hose Air 14 FT SOR 050350100 1 each Operator Manual for B-CAPTA SOR 45-95-90USA 1 each Edwards LifeScience/Baxter Truwave Cable SOR 0395-2049 4 each MTG Pad, Low Level II (100/case) SOR 23-41-51 1 case S5 LED Lamp SOR 35-05-80 1 each B-CAPTA Full System SOR 25-95-00 1 each YSI Temp Probe X2 SOR 45-03-10 1 each

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

The OKC is already using a LivaNova Sorin S5 perfusion machine within the surgery department. The OKC VAMC requires a second LivaNova Soring S5 Perfusion Machin in case the current system were to malfunction during surgery. By having a second, identical, machine it allows staff members, including surgeons, nurses, and perfusionists to seamlessly transition from one machine to another, if needed, without putting patients at risk. In an email dated 8/22/23 from Tomy Beasely, Account Executive Cardiopulmonary at LivaNova, it was conveyed that the heart lung machine with the pumps and the base, communicate with each other and that other accessories may be added, but they won’t fully communicate with the machine. Therefore, only the LivaNova accessories should be used for full compatibility. The OKC VAMC currently utilizes the software for this machine, which will allow the new machine to work on the same network. The OKC VAMC surgical staff members are already familiar with the Soring S5 system so no additional training would be required. The Soring S5 system has parts that are interchangeable and can be easily interchanged if one part of the system were to be defective. It is not ideal to have two different systems when a patient’s life is dependent on the machine.

Market research shows that if another manufacturer’s console were to be purchased it would cost an estimated

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

LivaNova was contacted to verify if there were any authorized distributors for these items. Veterans Healthcare Supply Solutions was identified as being an authorized distributor and are able to provide these items. A search on VIP, SAM, GSA, NAC contracts, and SAC contracts was also conducted as well as searching FPDS for previous purchases.

Last Updated: 02/01/22 Page 3 of 3

5. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

6. 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.

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