Attachment 1 FAR 13.5 Brand-name Justification - Over SAT (CO)_Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

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

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) 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 IRadimed 3880 is the first and only Non-Magnetic patient monitor. This device is FDA cleared to safely operate in 30,000 Gauss (3T) which is between 6 & 20 times closer than traditional MRI monitors with 1,500 to 5,000 Gauss limitations. Having a higher gauss rating improves patient safety, equipment reliability and workflow ergonomics. The 3880 is the only MRI patient monitor to feature Masimo SpO2 technology. Masimo is the SpO2 gold standard and leads the industry in SpO2 performance especially with patients with low perfusion. The IRadimed 3880 weighs less than 10 lbs and features a flexible mounting option that enables easy patient transport. This allows continuous monitoring from induction, through MRI scanning, and then recovery. Traditional MRI monitors weigh greater than 100lbs and their large size limits patient mobility. IRadimed 3880 is the only MRI monitor to feature wireless invasive blood pressure capabilities. This helps ensure that the invasive lines do not get dislodged from patient, table or staff movement, that could result in disruptions in monitoring. Traditional MRI monitors run extension IBP lines that often run across the floor to reach the monitor. The risk of cross contamination is greatly reduced since the 3880 can reside on the patient’s bedside eliminating the need for patient cables and tubing to come in contact with the floor like traditional MRI monitors. Potential trip hazards can also be reduced with this practice.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The required products and Services will be posted on Contract Opportunities, with a competitive small business set-aside. This will maximize competition amongst small business vendors.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: In accordance with FAR 13-106-3(a)(2)(ii), the proposed price will be determined fair and reasonable to the Government based on competitive pricing from small business vendors for the required product and service. If only one quote is received, the proposed price for products and services will be compared to previous purchases for the same and /or similar equipment and service to determine price fair and reasonable.