26-006589 - Sole Source Justification (BK Medical Software Update).docx

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UROLOGY ADVANCED BUNDLE
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26-006589
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This is a Sole Source Justification document for a limited competition procurement by the National Institutes of Health (NIH), Clinical Center, Department of Perioperative Medicine. The requirement is for a UroNav software update to the existing BK5000 ultrasound machine to support the E14CL4b Biplane Endocavity transducer for transrectal and transvaginal probe cases. The estimated contract value falls between $10,000 and $250,000. The justification cites FAR 13.106-1(b), asserting that only one source is available due to the product being exclusive to BK Medical, with no other manufacturer capable of providing the specific software update for the BK Medical ultrasound machine.

The procurement is driven by operational necessity, as the Clinical Center currently operates with only one available machine for surgical procedures, creating scheduling conflicts when multiple cases are booked simultaneously. The software upgrade will enable two operating rooms to function concurrently with separate providers, reducing delays and improving patient outcomes. The upgrade also provides enhanced image quality and improved ease of use. The requirement specifically supports prostate biopsy fusion cases for Dr. Pinto and Dr. Gurram. Market research confirmed BK Medical as the sole supplier of this specialized software update, and no competitive sources are available. The Contracting Agency is the NIH Office of Acquisition, with the signature date indicated as 5-18-26.

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JUSTIFICATION FOR LIMITED COMPELTITION

LIMITED SOURCES / BRAND NAME / SOLE SOURCE

($10,000 TO $250,000)

1. Requiring Activity: National Institutes of Health (NIH), Clinical Center (CC), Department of Perioperative Medicine.

2. Contracting Agency: NIH, Office of Acquisition, CC

3. Purchase Request#:

Description of Requirement: Request to procure a UroNav software update to the existing BK5000 ultrasound machine to support the E14CL4b Biplane Endocavity transducer Transrectal and Transvaginal probe cases. This is a request will support the ability for multiple cases to be performed in the same day running two Operating Rooms. The probe is specifically requested to support Dr. Pinto and Dr. Gurram prostate biopsy fusion cases. This is an upgrade to the existing BK Ultrasound machine providing better image quality and ease of use.

4. Authority permitting other than full and open competition (Check as applicable):

· GSA Federal Supply Schedules or Blanket Purchase Agreement:

__ _ FAR 8.405-6(a) (Circle as applicable):

A. An urgent and compelling need exists, and following the procedures would result in unacceptable delays;

B. 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; or

C. In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order or BPA must not have been previously issue under sole-source or limited-source procedures.

__ FAR 8.405-6(b):

Item(s) is peculiar to one manufacture (brand name, product, or feature of a product, is peculiar to one manufacturer, whether available on one or more schedules).

· Open Market:

__X_ FAR 13.106-1(b):

Only one source available (e.g., urgency, exclusive licensing agreement, brand name product, etc.).

5. Justification for action:

Currently there is only one machine available for surgery which makes it difficult when multiple cases are booked on the same day. By purchasing the software update to the existing machine this provides the ability to run two Operating Rooms at the same time with two different providers thus preventing delays and providing better outcomes for the day to day operations.

6. Market Research/Other Facts:

The proposed vendor, BK Medical is the only company that makes this specific software update for use with the BK Medical Ultrasound machine. There is no other company on the market that can provide this

7. Suggested Sources(s):

This is a sole source.

8. Steps to improve competition: N/A I hereby certify this justification is accurate/complete to the best of my knowledge and belief.

CUSTOMER SIGNATURE

(Technical Expert)

DATE: ____5-18-26_________

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