P03 - JA for IRADIMED IV Infusion Pump Systems - Signed.pdf

VHAPM Part 813.106 Page 1 of 1 Original Date: 08/30/17 Revision 02 Eff Date: 03/31/2020

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: 36C263-AP-4583

1. Contracting Activity: Department of Veterans Affairs, NCO 23, St Paul MN for the Iowa City VA

Medical Center, 636-20-4-4154-0729.

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

Iowa City, IA VAMC Radiology department currently has a need for 2 MRI safe IV medication pumps and an MRI safe patient monitor. These devices will allow for the performance of MRI exams on patients needing conscious sedation.

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: The current process at the Iowa City VA involves placing IV infusion pumps in the MRI control room (separate room from patient), adding 25 to 35 feet of IV extension tubing to the primary line, and then running IV tubing under the MRI door. The door is cracked open. The tubing is then run across the unsterile scan room floor and finally reconnected to the patient in the MRI scanner. The current pumps are not MRI compatible IV infusion pumps and therefore the facility are forced to use this workaround process. This workaround process is non-compliant with Joint Commissions Sentinel Event Issue 38 and potentially creates serious patient and staff safety risks. The 6 most dangerous patient/staff safety risks using this process are: Missile Effect” & “Projectile Injury, Patient Coding, Inaccurate Flow Rate, Delayed Occlusion Warning, Post Occlusion Relief Bolus, and Hospital Acquired Infections. The use of MRI compatible IV pumps is not only considered the safest practice for delivering IV medications within the MRI but is also the standard-of-care that is expected today. Worldwide there is only one non-magnetic MRI compatible IV infusion pump on the market. It is the MRidium MRI IV Infusion System by Iradimed Corporation.

The MRidium System is comprised of an MRI compatible (non-ferromagnetic) pump that can safely enter the MRI scan room with the patient. This completely eliminates the patient and staff safety risks associated with the current workaround process.

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

Searched GSA, VETBIZ and previous purchase information. Also contacted the manufacturer. These items are not available from the GSA. GSA search was for category A-64, IV Pumps. VETBIZ query under NAICS 334516 and MRIDIUM resulted in zero VOSB/SDVOSB vendors. Rule of two not met for VOSB/SDVOSB set aside. This equipment is only available from the manufacturer as confirmed via conversation and documentation.

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.

Name Date

09/05/2020 https://www.acquisition.gov/?q=/browse/far/13 https://acquisition.gov/far/current/html/Subpart%2013_1.html#wp1125466