P03 - Brand Name Justification Medrad Mark 7 Arterion Injection System Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification for Brand Name Awards IAW FAR 13.106 1 For

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

Acquisition Plan Action ID: 36C252 24 AP 1201

1. Contracting Activity: Department of Veterans Affairs, VISN 12, Clement J. Zablocki VA Medical Center has submitted 2237 695 24 2 969 0083 for a Medrad Mark 7 Arterion Injection System to the Great Lakes Acquisition Center (NCO12).

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

This justification and approval is for a Medrad Mark 7 Arterion Injection System which will be awarded as a firm fixed priced purchase order.

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

The Milwaukee VAMC is frequently using the Electrophysiology lab (EP Lab) as a backup to the Cardiac Cath lab. While the Cath lab currently uses the Bayer Injection System, the EP lab does not currently have such system in place. Therefore, both procedural labs should be equipped with the system to enable the interventional cardiologists to perform coronary interventions. Currently, Veterans are exposed to higher amounts radiation due to the required sedation and procedural times with only having one (1) available injection system. This also leads to prolonged time on the procedural table which poses the potential of increased discomfort and risk for pressure injury.

While there may be similar products on the market, the Cath lab is currently using the Bayer Medrad Injection system which uses disposables that are fully stocked within the lab. These disposable items are only compatible with the Bayer Medrad Injection system and no other devices. The purchase of an opposing brand will lead to the requirement of purchasing and using two separate disposable items within the same department. This will also require additional storage space, training, and a change in workflow. With two different disposable sets being used, this also poses the risk of clinicians using the incorrect set that can potentially lead to delays and damage to the devices.

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

Original Equipment Manufacturer (OEM) for this requirement is Bayer Healthcare LLC. who is considered an Other Than Small Business (OTSB) per System for Award Management (Sam.gov) Reps & Certs. A SBA – DYNAMIC SMALL BUSINESS Search of NAICS 334510 keywords “Medrad Mark 7 Arterion Injection System” identified zero (0) SD VOSB vendors. An inquiry to the OEM was completed to maximize competition. OEM identified it has only one authorized SDVOSB distributor that can meet the requirement. The Company is

(SDVOSB). An Intent to Sole Source was posted on sam.gov from 5/2/2024 5/6/2024 one (1) response received from (SDVOSB), CS verified they can meet the requirement. Therefore, A Service Disabled Veteran Owned Small Business Set aside is appropriate IAW with VAAR 819.7006.

Based on the information provided above, it is determined this procurement shall be set aside for Service Disabled Veteran Owned Small business (Open Market/Brand Name), and that the award can be made at a fair and reasonable price that offers the best value to the United States IAW 13 CFR § 121.406(b), FAR 13.106 1(c), and VAAR 819.7006.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106 1(c). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.