JA REDACTED.pdf

CUI//SP-SSEL

Control Number: 24-RHCO-C-295

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

2 SEP 2021

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Medical Readiness Contracting Office-West (MRCO-W)

2. Description of Action: MRCO-W intends to issue a sole source firm fixed price contract to Iradimed Corporation for the purchase of seven (7) MRidium MRI Infusion systems for the Department of Radiology (DOR), MRI, Brooke Army Medical Center, Joint Base San Antonio- Fort Sam Houston, Texas.

Type of Funds: FY24 DHP. Purchase Request 0012123972

An acquisition plan is not required, as this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

3. Description of Supplies/Services: This requirement is for the purchase of seven (7) MRidium MRI Infusion systems. The MRidium MRI infusion system consists of the following: MRidium MRI Infusion System with SpO2, MRidium side car modular pump, MRidium wireless remote control, MRidium non-magnetic IV pole, Reusable grip sensor pack, MRidium SpO2 fiber optic sensor kit, DERS initial library entry bundle and Training (IV pump). The MRI infusion pumps are used to provide continuous delivery of medications to severely ill patients.

4. Authority Cited: 41 USC 1901 as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

5. Reason for Authority Cited: This is a sole source requirement and only one responsible source can satisfy the agency’s requirement. DOR MRI has demonstrated an urgent need for the MRI infusion systems due to the loss of six of their current MRidium MRI Infusion systems, which leaves three systems that are at or near end of life. Without the new pumps, MRI is at high risk of becoming unable to provide continuous delivery of medications within the MRI suite. This would prohibit scanning severely ill patients requiring continuous infusions of medicines, jeopardizing the mission of BAMC in providing accurate and timely care to its beneficiary population. The MRI Infusion Systems being procured must be compatible with the existing MRI Infusion systems currently being used by DOR MRI and the parts must be interchangeable.

MRidium MRI Infusion systems are proprietary in nature and IRADIMED Corporation is the sole manufacturer of the required infusion systems. There are no alternative products or manufacturers capable of meeting the needs of this requirement.

MRI Infusion System Salient Characteristics:

Double pump assembly Wheeled MRI sage pole mount 10,000 Gauss magnetic field limit Flow rate range, 0.1 to 1400 mL/hour in 0.1 to 1 mL/hour increments Occlusion detector Air in line detector

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

3 SEP 2021

KVO capability MRI magnet strength capability from .02 to 3.0 Tesla Programable drug library Remote pump controller Rechargeable battery operated with system interchangeable batteries.

6. Efforts to Obtain Competition: In accordance with FAR 5.2, a Special Notice of Intent to sole source was posted on SAM.gov on 18 July 2024, inviting interested vendors to provide a response prior to 23 July 2024. No responses were received. Based on market research, competition is not anticipated for this requirement. Due the nature of the requirement, subcontracting opportunities are not available. This J&A will be posted within 14 days after contract award. The Government will continue to assess the market for new entrants.

7. Actions to Increase Competition: After award, this justification will be available on SAM.gov Contract Opportunities. If in the future other compatible products become available, market research will be performed to consider other sources that meet or exceed the current requirement.

Additionally, an evaluation of the market will be conducted prior to any renewal related to this requirement. Pricing, availability, and any alternative solutions will be the focus of that research.

The contract file will be properly documented with any findings.

8. Market Research: IAW FAR Part 10, market research has been conducted for this acquisition.

A thorough search was conducted via internet websites https://www.esutures.com/, https:// www.contractdirectory.gov/contractdirectory, https://www.medicalecart.com/ and https:// www.va.gov/nac/MedSurg/List as well as GSA Advantage/eLibrary, to identify any potential contractors supplying “MRidium MRI Infusion systems.” A Google search was also conducted using “MRidium MRI Infusion systems.” No sources were identified that could satisfy the needs of this requirement.

The Small Business Administration’s Dynamic Small Business Search (DSBS) https://dsbs.sba.gov/ was utilized to identify small businesses capable of fulfilling the requirements of this acquisition. DSBS was queried using NACIS Code 334510 and the key words “MRI Infusion Pump” to identify small businesses and determine potential set asides or subcontracting possibilities. No sources were identified capable of meeting the needs of this requirement.

The requiring activity conducted a search via Defense Logistics Agency’s Electronic Catalog (ECAT), items to be procured are available via ECAT.

9. Interested Sources: To date, no other sources have written to express an interest in this requirement. As stated in paragraph 6 above, the notices required by FAR 5.201 have been published, and there are no sources that could provide the entirety of the Government’s requested requirement at this current time.

10. Other Facts:

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

4 SEP 2021

a. Procurement history - This is a first-time new requirement.

(1) Contract numbers and dates of all awarded contracts for these same requirements.

Not applicable.

(2) The competitive status of these actions.

Not applicable.

(3) Authority previously cited if less than full and open competition was used.

Not applicable.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results.

Not applicable.

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources.

Not applicable.

(6) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys.

Not applicable.

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes.

Not applicable.

b. Other facts. Not applicable

11. Technical/ Requirements Certification:

I certify 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.

HCO-C-295

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

5 SEP 2021

12. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable. The IGE, historical procurement data, and market research will be used to determine that the price is fair and reasonable. Certified cost or pricing data is not required as the exception applies IAW FAR 15.403-1(b)(3).

13. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.