Justification FAR Part 13 (JA) (JUNE 2025) copy_Redacted.pdf

CUI//SP-PROCURE

Control No: 25 MRCO-P 187

JUNE 2025

FAR Part 13 Justification and Approval Simplified Procedures for Certain Commercial Products

1. Requiring Activity: Neurology Clinic, Madigan Army Medical Center (MAMC), Joint Base Lewis-McChord (JBLM), Washington.

2. Contracting Activity: Medical Readiness Contracting Office – Pacific (MRCO-P), Joint Base Lewis-McChord Health Contracting Branch (JBLM-HCB), JBLM, Washington.

3. Description of Action: Requesting approval to award a new non-competitive, one-year Firm Fixed Price (FFP) contract to Nihon Kohden America, LLC (CAGE Code: , Address: 15353 Barranca Pkwy, Irvine, CA 92618) for Electroencephalograph (EEG) Acquisition System and associated equipment. The contract will be fully funded using Fiscal Year (FY) 2025 Defense Health Program (DHP) funds.

4. Description of Supplies/Services: This requirement is for EEG Acquisition System and associated equipment to support the Neurology Clinic’s mission with new and upgraded equipment to replace the current EEG Acquisition System that has reached its life expectancy. EEG equipment allows for expanded capabilities associated with testing and diagnosis of long-term epilepsy, continuous Electroencephalography (cEEG) Intensive Care Unit (ICU) monitoring, and sleep disorders. The Neurology Clinic is requesting three portable EEG Acquisition Systems, two ambulatory EEG systems, and one wireless EEG headset compatible with existing Government owned equipment (Neurofax EEG-1200A Premium Acquisition System and components from Nihon Kohden America) already in place at MAMC, as well as installation and training. The estimated value for the equipment is . The expected delivery/performance dates for the required equipment are no later than (NLT) 120 days after receipt of order (ARO) and/or installation of equipment and/or clinical training will be NLT five months after delivery of equipment.

5. Authority Cited: Title 41 U.S.C. §1901(e)(2) as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial products.

6. Reason for Authority Cited: Only one source is capable of providing the required EEG Acquisition System and associated equipment.

a. Background: MAMC requires the Nihon Kohden EEG Acquisition System and equipment (Nihon Kohden platform) to maintain continuity of patient studies and medical records. Awarding the contract to another company would result in MAMC losing EEG studies and patient data that were completed on the current Nihon Kohden platform over the last 10 years, as well as loss of critical functionality needed for the

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Neurology Clinic to meet patient needs. Additionally, no other company would be able to read the EEG studies that were completed on the current Nihon Kohden platform.

According to the Health Information Portability Privacy Act (HIPAA) subsection of 45 CFR §164.316(b)(2)(i), such records must be kept for a minimum of six years after their creation or, if the document outlined a policy, six years from when the policy was last implemented. Thus, if a policy was in place four years before it was either dropped or altered, the original documentation must be kept for at least ten years from its creation.

Therefore, MAMC must be able to access the data completed on the Nihon Kohden platform since 2015 which is when the existing Government owned EEG system and equipment/platform was purchased. In addition, this is the only system and equipment compatible with the existing Government owned Neurofax EEG-1200A system manufactured by Nihon Koden, which must be used together to produce the required studies, patient data, and medical records.

b. Alternatives: None. Use of in-house resources and conducting a competitive acquisition is not possible since upgraded equipment can only be obtained from Nihon Kohden America, and it is the only system compatible with the existing Government owned EEG-1200A. Therefore, the only acceptable alternative is the approval of this justification and contracting without providing for full and open competition.

c. Impact if Not Approved: Nihon Kohden America, LLC is the original equipment manufacturer (OEM) for the requested equipment and has confirmed that they do not have any authorized distributors. Therefore, as the OEM, they are the only company that can meet the Government’s requirement. Without the EEG Acquisition System and associated equipment, the Neurology Clinic’s mission would be adversely affected as they could not treat their patients or meet their needs requiring appointments to be canceled and diverting patients to providers in the economy. The upgraded system and equipment from Nihon Kohden America, LLC is critical to patient care, safety, and soldier readiness.

7. Efforts to Obtain Competition: The notice required by FAR 5.201 will be published on the SAM.gov website and any quotation received shall be considered.

a. Effective Competition: A Sources Sought notice was posted on SAM.gov on 30 April 2025 for one week inviting all responsible sources to submit capability statements before the closing date on 7 May 2025. Three responses were received and upon review, none of the respondents can meet the Government’s needs pertaining to compatibility of existing equipment. The Requiring Activity reviewed the capability statements provided by Cadwell Industries, FGI Global Solutions, and Rhyfel, Inc. and determined that they are not capable of meeting the Government’s requirement because their systems are not compatible with the Government owned EEG-1200A system.

b. Subcontracting Competition: In accordance with FAR 19.705-2(a)(1) and FAR 19.702(a)(1)(i), the proposed total contract dollars will not exceed the subcontracting

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order to access and save EEG studies and patient medical records completed on the Nihon Kohden platform over the last 10 years.

5) Unusual Patterns Revealed by Procurement History: None

6) Protests Received and Actions taken in Response: None

b. Other Facts. None