P03 PG_Part808.405-6_Atch1_Limiting_Sources_Justification_MPT-SAT Signed.pdf

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EDX Ultrasound
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36C26326F0127
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This is a Justification for Limiting Sources (LSJ) document for a Federal Supply Schedule (FSS) order under FAR 8.405-6, issued by the Department of Veterans Affairs, Network/Program Contracting Office 23, in support of VISN 23 VA Health Care System located in Des Moines, Iowa.

The procurement covers two complete Natus EDX (electrodiagnostic/EMG) systems valued at $90,364.62 to replace legacy units lacking electronic health record (EHR) integration and advanced signal processing capabilities. Each system includes the EDX base unit and amplifier, Windows desktop PC with software (Natus Elite v2 Software, Viking, EMG Server Software), EMG USB control panel, comfort probe, test modules, UB4 cart with monitor, Nicolet isobox, LCD monitor, laser printer, HL7 EMG interface components for VA EHR integration, and installation and training. The order will be placed against FSS Contract Number 36F79718D0330 with the brand manufacturer Natus Medical Incorporated (3150 Pleasant View Road, Middleton, WI 53562).

The contracting officer justified the single-source limitation under FAR 8.405-6(b) based on items being peculiar to one manufacturer. Market research documented in the Streamlined Market Research Report (Acquisition ID# VA-26-00065797, dated 5/3/2026) confirmed that the Natus EDX platform uniquely provides: validated HL7 integration with VA EHR over the medical VLAN with secure PHI/PII handling, continuity of clinical records compatible with existing archived Natus studies, reliable VA network compatibility, and manufacturer training/support tailored to the VA environment. Competing suppliers (Cadwell Sierra Summit, Nihon Kohden Neuropack, Neurosoft Neuro-MEP) lacked one or more facility-critical factors. The PSC is 6515 and NAICS code is 334510 (small business size standard, no SBA certification required). The justification was signed by Marie Weathers, Contracting Officer, NCO 23, on August 26, 2026, and will be posted on e-Buy as required by FAR 8.405-1(e).

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Justification for Limiting Sources for Micro-Purchase Threshold up to the SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 3 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C263-26-AP-3553

DEPARTMENT OF VETERANS AFFAIRS

FAR 8 – Justification for Limiting Sources (LSJ) For

Limiting Sources (<SAT)

Acquisition Plan Action ID: 36C263-26-AP-3553

1. Contracting Activity: Department of Veterans Affairs, Network/Program Contracting Office 23, located at Address, in support of VISN 23 VA Health Care System at 3600 30th St Des Moines IA 50310

2. Description of Action: This action will be awarded as a new requirement placed as an order against the vendor's Federal Supply Schedule (FSS) contract, for two (2) advanced electromyography (EMG) and nerve conduction study systems to replace legacy units that lack electronic health record (EHR) integration and advanced signal processing features.

Order against: FSS Contract Number: 36F79718D0330

Name of Proposed Contractor: Natus Medical Incorporated (brand manufacturer) Street Address:3150 Pleasant View Road City, State, Zip: Middleton, WI 53562 Phone:608.829.8500

3. Description of Supplies or Services:

The estimated value of the proposed action is $ 90,364.62

This procurement provides two (2) complete Natus EDX (electrodiagnostic/EMG) systems for VA-CIHCS to replace legacy units lacking EHR integration. Each system includes:

• EDX Base Unit and EDX 2-channel Amplifier

• EDX Windows Desktop PC, MS Word, North American power cord

• Natus Elite v2 Software – Viking; Natus Elite v2 Reader Software; EMG Server Software

• EMG USB Control Panel II with cable

• Comfort Probe Plus (WR50); NCS and EMG test modules

• UB4 Cart with monitor arm; EDX Amplifier Holder & Arm

• Nicolet 115V Isobox; 24-inch LCD monitor; 120V laser printer

• Natus HL7 EMG Basic Interface (P/N 018853), HL7 EMG Workstation License, and HL7 EMG

Implementation Labor (Advanced) for integration with the VA EHR

• Installation and training (included; coordinated at the ordering level)

• The systems provide multi-channel simultaneous EMG/NCS acquisition, advanced low-noise signal processing, HL7 export to the EHR, electronic waveform storage/review and report editing, and IEC 60601-compliant patient isolation, and are configured to operate on the facility medical VLAN while preventing external transmission of PHI/PII. These items are peculiar to one manufacturer (Natus Medical Incorporated), as identified by the Natus/Nicolet brand-specific part numbers throughout the quote.

VHAPG Part 808.405-6 Limiting Sources Page 2 of 3

Acquisition ID#: 36C263-26-AP-3553

• Market research was conducted for this requirement in accordance with FAR Part 10, VAAR 810, and VAAM M810, and is documented in the Streamlined Market Research Report for Requirement 636-26-4-3260-0044 (Acquisition ID# VA-26-00065797, prepared by Eddie Gutierrez, VA-CIHCS, dated 5/3/2026 and reviewed by Denise Behrends 7/30/2026). The techniques used included (1) application of the personal knowledge and direct experience of VA- CIHCS biomedical support staff and subject matter experts who have evaluated and operated multiple EMG platforms in the VA environment, and (2) consultation with knowledgeable individuals in Government, most notably the VA-CIHCS Physical Medicine & Rehabilitation (PM&R) lead physician, who is the primary end user and has substantial prior experience with the Natus EDX platform in both VA and other clinical settings.

• Results: Competing EMG/NCS suppliers (both large OEMs and small businesses) were evaluated.

Research established that the Natus EDX platform provides validated HL7 integration with the VA EHR over the medical VLAN, secure PHI/PII handling with no external data transmission, high reliability and user satisfaction across VA facilities, and manufacturer training/support tailored to the VA environment. Competing offerings evaluated lacked one or more facility-critical factors (validated VA-EHR HL7 interface, reliable VA-network compatibility, or manufacturer training/support at the required level), and none provided the established clinician proficiency and operational track record that Natus EDX provides at VA-CIHCS. The PSC is 6515 and the NAICS code is 334510 (size standard: Small – No SBA certification). The estimated value, including all items, is $90,364.62.

4. Authority:

Order Against FSS: Authority of the Multiple Award Schedule Program, Title III of the Federal Property and Administrative Services Act of 1949 (41 USC 251, et seq.); Title 40 USC 501, Services for Executive Agencies; and Section 803 of the National Defense Authorization Act of 2002 (PL 107-107) and implemented by FAR 8.405-6. Mark the applicable exception:

An urgent and compelling need exists, and following the procedures would result in unacceptable delays(FAR 8.405-6(a)(1)(i)(A);

Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized; (FAR 8.405- 6(a)(1)(i)(B));

In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order and the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order was not previously issued under sole-source or limited-sources procedures (FAR 8.405-6(a)(1)(i)(C)); or

Items peculiar to one manufacturer. An item peculiar to one manufacturer can be a particular brand name, product, or a feature of a product, peculiar to one manufacturer). A brand name item, whether available on one or more schedule contracts, is an item peculiar to one manufacturer (FAR 8.405-6(b)).

Rationale/explanation to support cited authority:

https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-8#FAR_8_405_6

VHAPG Part 808.405-6 Limiting Sources Page 3 of 3

Acquisition ID#: 36C263-26-AP-3553

This rationale is consistent with the Streamlined Market Research Report for Requirement 636-26-4- 3260-0044 (Acquisition ID# VA-26-00065797, prepared by Eddie Gutierrez, dated 5/3/2026). This is a brand-name action limited to the Natus brand

Continuity of the clinical record / archived study compatibility. Current system (Caldwell) cannot integrate into EHRM. It is also outside of service protection due to age and therefore cannot be upgraded. VA-CIHCS needs to maintain existing patient EMG/NCS studies stored in Natus (Elite/Viking) format. Clinicians must be able to retrieve, review, and compare prior studies against new studies for longitudinal diagnosis. A non-Natus system cannot import without loss of these archived studies, creating a gap in continuity of care. Current process is using a password protected encrypted thumb drive to get the report from the existing Caldwell brand.

Existing security-authorized HL7/EHR interface on the VA network. VA-CIHCS has an external transmission process through a secured thumb drive. Introducing the Natus brand would allow for integration and interface on the VA network.

End user/biomed: Review the published specifications of competing EMG/NCS systems (e.g., Cadwell Sierra Summit, Nihon Kohden Neuropack, Neurosoft Neuro-MEP).

5. BRAND NAME ONLY: This buy is estimated to exceed $25,000 and this documentation will be posted along with the RFQ on e-Buy, as required by FAR 8.405-1(e).

6. Note that this determination satisfies the requirements of FAR 8.405-6. The requirement to prepare a written justification IAW FAR 6.303 does not apply to Federal Supply Schedules.

Marie Weathers Contracting Officer

NCO 23

Date: 08/26/2026 https://www.acquisition.gov/far/part-8#FAR_8_405_6 https://www.acquisition.gov/far/part-6#FAR_6_303

2026-08-26T13:22:22-0600
MARIE WEATHERS

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