P03 - JA OVER SAT WELLSENSE_Redacted.pdf

Effective Date: 11/15/24

REVISION: 01

Acquisition ID#: 36C248-25-AP-4592

( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

Wellsense, Inc. is the original equipment manufacturer (OEM) and holds all proprietary rights for the Wellsense VU Advanced Pressure Visualization System, which is highly specialized equipment (Sole Source Letter in eCMS Briefcase). Wellsense, Inc. is the only manufacturer that can provide the necessary maintenance to the Wellsense VU Advanced Pressure Visualization Systems owned by JAHVH. Maintenance and repairs performed by an unauthorized vendor can void the warranty issued by the OEM and cause major delays with patient care if the units are not in operable status. These Wellsense VU Advanced Pressure Visualization Systems must be properly maintained to assure proper functionality and must be kept to OSHA Standards, which in return will reduce equipment down-time and avoid any delays or lapse in patient care at JAHVH.

The Wellsense VU Advanced Pressure Visualization System technology provides the visual and evaluative feedback required for real-time pressure assessment and monitoring to ensure patients are repositioned effectively based upon proprietary software and hardware designs that are wholly owned and held by Wellsense, Inc.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

The Contracting Officer (CO) posted a Special Notice of Intent to Sole Source directly to Wellsense, Inc., as this approach ensures that only one Wellsense, Inc. could provide the necessary all-inclusive maintenance services JAHVH is requesting.

On 07/14/2025, a Special Notice of Intent to Sole Source (RFQ# 36C24825Q0970) was successfully posted via www.SAM.gov (Contract Opportunities) to see if any interested vendors/firms can provide an all-inclusive maintenance services for the Wellsense VU Advanced Pressure Visualization Systems.

On 07/22/2025, the RFQ closed, and zero (0) vendors/firms responded, thus confirming that no other vendor/firm is capable/authorized on providing any maintenance services for the Wellsense VU Advanced Pressure Visualization Systems that is owned by Wellsense, Inc.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable:

The estimated cost for the Wellsense VU Advanced Pressure Visualization Systems Maintenance Service is $691,200.00 (Base plus three (3) Option Years), as reflected in the IGCE. The CO determined the anticipated cost to the Government will be Fair and Reasonable based on a comparison with similar items that have been procured within both the VHA and Federal Government. The CO was able to confirm that other VA Medical Centers currently have active contracts for the same exact Wellsense VU Advanced Pressure Visualization Systems all-inclusive maintenance service that JAHVH is requesting. The CO confirmed that the unit prices for Wellsense

Effective Date: 11/15/24

REVISION: 01

Acquisition ID#: 36C248-25-AP-4592

VU Advanced Pressure Visualization Systems under Contract #36C24822P0447 at West-Palm Beach VA Medical Center are in alignment with the proposal that was presented to JAHVH. This comparable data was used as part of the final fair and reasonable price determination with this procurement.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

Market Research was conducted in accordance with (IAW) FAR Part 10 and revealed that Wellsense, Inc. is the original equipment manufacturer (OEM) for the Wellsense VU Advanced Pressure Visualization Systems JAHVH currently owns. As stated above, the CO posted a Special Notice of Intent to Sole Source to Wellsense, Inc. to ensure that only one (1) source could provide the necessary Wellsense VU Advanced Pressure Visualization Systems Maintenance Services.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

On 07/10/2025, Wellsense, Inc. provided our office with a Sole Source Letter (SSL) confirming that Wellsense, Inc. is the original manufacturer and exclusive distributor for these systems (P03 Sole Source Letter in eCMS Briefcase). No other vendors/firms can perform the necessary maintenance, repairs and/or warranty claims for the Wellsense VU Advanced Pressure Visualization Systems.

The proprietary nature of this equipment restricts other vendors/firms from being able to provide the complete support these systems need.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

None, as Market Research confirms that no vendor/firm can provide the Wellsense Systems Maintenance Services, according to the results on the RFQ Special Notice of Intent to Sole Source that closed on 07/22/2025.

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required:

VHA is committed to the competitive spirit of all procurement regulations. It is our policy to seek full and open competition to the largest extent possible while fulfilling the necessary requirements.

Currently there is no anticipated competition for the Wellsense VU Advanced Pressure Visualization Systems. Should Wellsense, Inc. in the future have authorized vendors/providers to perform maintenance or warranty services, the Federal Government will consider them for competition.