Single Source Brand Name Memorandum.pdf

Controlled by: Defense Health Agency Controlled by: DHA-CA, WM-CD CUI Category: General Procurement and Acquisition Distribution/Dissemination Control: FEDCON POC:_Christopher_Shaw, christopher.j.shaw26.civ@health.mil

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SOLE SOURCE CONTRACTING OFFICER’S MEMORANDUM

for

Sole-Source (Including Brand-Name) Acquisitions of Commercial Items Conducted Pursuant to FAR 13.106(b)(1) Below the Simplified Acquisition Threshold

Purchase Request No. 0011874458

1. Identification of the agency and contracting activity: Naval Hospital Bremerton (NHB), Defense Health Agency Contracting Activity (DHACA), Western Markets Contracting Division

(WMCD).

2. Description of Supplies/Services (including quantity and dollar value): The proposed fixed price contract action is for the purchase of a Medtronic NIM Vital intraoperative neuromonitoring device for the Ear, Nose and Throat (ENT) Department at NHB. The Nerve monitor device allows for real time evaluation reducing the risk of injury to critical nervous structures that has a liquid-crystal display screen and can be used in operative procedures to show a real time evaluation of critical nervous structures.

1 EA Medtronic; NIMVITAL-WCART-2PI BUNDLE NIM VITAL SYS W/CART

NIMVITAL-NIM4CM013.

3. Demonstration of contractor’s unique qualifications: The subject matter expert, and applicable market research, has confirmed that the Medtronic product is the sole intraoperative neuromonitoring product available for real time evaluation during surgery. Market research has confirmed that other agencies have posted notices of intent, and awarded as sole-source or brand name procurements.

The comparable specifications required by NH Bremerton for this requirement are as follows and not available from other manufacturers:

• Must be able to provide advanced nerve monitoring technology.

• System must be touchscreen and offer multiple modes for multiple functions.

• Must have bur and electrode integration capability to properly review the patient’s consciousness.

• Must be compatible with an operative setting have four different channels that can alternate depending upon the procedure.

• Must have the ability to utilize an endotracheal tube.

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• System must be medical grade and designed for continuous duty.

• System dimensions must measure no larger than 30 cm wide by 35 cm high by 30 cm deep.

• System must weigh no more than 10 kg.

• Must be cleared by the FDA.

No other device will meet these requirements.

4. Market Research: Market Research was conducted by technical experts in December 2022.

This search consisted of review of similar procurements and a review of open market contractors and Federal Supply Schedule contractors. Search engines utilized included Google, EDA, DLA, and FPDS-NG. Additionally, the Contract Specialist queried GSA eLibrary, AbilityOne and Unicor with none available.

The applicable NAICS code for this requirement is 339113, Surgical Appliance and Supplies Manufacturing.

The applicable PSC for this action is 6515 Medical and Surgical Instruments, Equipment, and Supplies

Medtronic has approved SDVOSB small business resellers of their products, and it is expected that we will receive 2 or more quotes. Based on the information provided, it is in the Government’s best interest to issue as a SDVOSB set-aside.

See attached Market Research Report for detailed information.

COORDINATION:

6. Technical/Functional Representative:

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

1/6/2023 Marina Dewalt Date Supply Petty Officer

7. Contract Specialist:

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

1/6/2023 Christopher Shaw Date Contract Specialist

APPROVAL:

DEWALT.MARINA.LEANN.1279939

Digitally signed by

DEWALT.MARINA.LEANN.1279939057

Date: 2023.01.06 09:15:40 -08'00'

SHAW.CHRISTOPHER.JOH

N.1273447454

Digitally signed by

SHAW.CHRISTOPHER.JOHN.1273447454

Date: 2023.01.06 09:22:16 -08'00'

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9. Contracting Officer:

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

1/6/2023 Reagan Pablo Date Contracting Officer, Western Markets Contracting Division

Digitally signed by

PABLO.REAGAN.SOLIS.1166353536

Date: 2023.01.06 09:24:30 -08'00'