WaveMark JA Approved.pdf

Effective Date: 11/15/24 Page 1 of 5

REVISION: 01

Acquisition ID#: 36C261-25-AP-2267

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261-25-AP-2267

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Health Administration, Regional Procurement Office West, Network Contracting Office (NCO) 21 on behalf of Veterans Affairs Palo Alto Health Care System (VAPAHCS).

PR 2237: 640-25-2-554-0011

2. Nature and/or Description of the Action Being Processed:

This new procurement is for the Catherization Lab WaveMark license in order to continue use of the WaveMark supply tracking and management system in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2. This system facilitates the safe and efficient use of cath lab supplies (e.g., stents) used on Veterans in the cath lab and other clinical areas. This requirement will be a firm-fixed price contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

WaveMarkTM Solutions (WaveMark, Inc) are in use at Veterans Integrated Service Network (VISN) 21 Medical Centers and VAPAHCS. The WaveMark Solutions automates the entry of new supplies into the Cath Lab inventory as well as documents the supply use in Veteran procedures. It interfaces with Generic Inventory Package to automate supply re-order as well as with the CART-CL (Clinical Assessment, Reporting, and Tracking - Cath Lab) to document supply usage. WaveMark sends notifications to supply chain staff and cath lab managers when cath lab supply types such as stents, catheters, etc. are running low, as well as when individual supplies are reaching, or have passed their expiration dates. They also notify them of supply recalls and there is risk in Veteran harm (infections, surgical complications and even death) if expired and/or recalled supplies are used. As a result, WaveMark greatly reduces the risk of Veteran studies being delayed or cancelled due to necessary supply unavailability, as well as VA funds lost to supply spoilage. This contract procures hardware (e.g., supply cabinets and point-of-use workstations), software, modules, and interface maintenance services to keep the system operational at VISN 21 VA Medical Centers.

Effective Date: 11/15/24 Page 2 of 5

Acquisition ID#: 36C261-25-AP-2267

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) 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):

Medical Centers' supply chain management systems are crucial for ensuring that healthcare providers have the right medical supplies at the right time and place for patient care. These systems encompass a range of processes, including procurement, inventory management, distribution, and logistics, supported by specialized software. The specialized software has licensing rights between the owner and the user. WaveMark, Inc developed and owns the proprietary rights to WaveMark Solutions and their interfaces with VA supply management system. The declaration letter from WaveMark, Inc states that third party vendors are not allowed access to edit the WaveMark Solutions software and firmware on the hardware.

Therefore, only WaveMark, Inc can perform the necessary work to keep the system operational and compliant with VA regulations. WaveMark Solution is hosted at the VA Information Technology Infrastructure Operations Center (ITIOC) located in Austin Texas.

The radiofrequency identification cabinets and physical point-of-use workstations are deployed in cath labs for patient care throughout VISN 21. At this juncture the sole source is predicated on WaveMark, Inc retaining control over their equipment and software. It is anticipated VA medical stations will eventually seek alternative supply management systems, until then based on proprietary elements, patent declarations, and no third-party entities authorized to service WaveMark Solutions.

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

Until WaveMark, Inc allows third party vendors to provide equipment maintenance, module and interface maintenance and user training for WaveMark Solutions, these services cannot be accomplished by anyone other than WaveMark, Inc.

Effective Date: 11/15/24 Page 3 of 5

Acquisition ID#: 36C261-25-AP-2267

Once it has been established that this work cannot be accomplished by third party vendors, VISN 21 evaluated the cost effectiveness of replacing the WaveMark Solutions with other cath lab supply management solutions. VISN 21 has determined that replacing the WaveMark Solutions would incur unacceptable costs associated with decommissioning of the current system and procurement of new solution. In addition, delays to patient care (e.g., due to VA OIT requirements for an authority to operate in VA) would be unacceptable to VISN 21’s medical centers. The only cost-effective option is to return to tracking supplies manually on a shared MS Excel Spreadsheet (or other equivalent manual tracking process).

This process is prone to human errors and does not have the capability to automatically catch expired supplies at point of care.

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

It is anticipated that the price submitted by WaveMark, Inc will be comparable to existing contracts for similar services. FAR Part 13.106-3(a)(ii) comparison of the proposed price with prices found reasonable on previous purchases will be utilized to determine price fair and reasonableness.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

A SBA Small Business search with North American Industry Classification System code 513210 Software Publishers resulted in 7 service disabled veteran owned small business and 5 veteran owned small business vendors which are unable to provide services due to the proprietary nature of the equipment. General Services Administration eBuy did not possess vendors for WaveMark Solutions equipment or services. NASA Solutions for Enterprise- Wide Procurement did not result in WaveMark Solutions or EiRTLS vendors. WaveMark, Inc possess General Services Administration contracts V797D-60688 V797P-430B, GS-07F-5873R however, these contracts don't include WaveMark Solutions. A notice of intent Notice ID: 36C26125Q0787 with Product service Code J065 (Maint/Repair/Rebuild of Equipment –Medical, Dental, & Veterinary Equipment & Supplies) was posted on Sam.gov Contract Opportunities July 28, 2025 to August 1, 2025, with no responses receieved. A sources sought Notice ID: 36C26125Q0787 posted on Sam.gov Contract Opportunities with product service code J065 (Maint/Repair/Rebuild of Equipment – Medical, Dental, & Veterinary Equipment & Supplies) , posted July 28, 2025 – August 1, 2025, no respondents to either posting.

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

Wavemark has a current VA-owned interface with Cerner: another expanding enterprise project that solidifies service requirement for the upkeep of the WaveMark Solution in VISN

21. The core element in this type of interface environment is that all medical centers be equipped with the devices that are configured and able to interface with the VA enterprise record systems. Based on ubiquity of the WaveMark Solutions throughout VISN 21 and need for automated cath lab supply management, sole source to WaveMark Inc is non-optional for medical centers using WaveMark Solutions.

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

WaveMark Inc.

Effective Date: 11/15/24 Page 4 of 5

Acquisition ID#: 36C261-25-AP-2267

300 Baker Ave, Ste 207 Concord, MA 01742

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:

VISN 21 Healthcare Technology Management, Supply Chain Management, and cath lab clinical staff are continually evaluating their current supply management system need and product offerings within the industry. Once the VISN 21 medical centers’ need surpasses the product offering of WaveMark, the restrictive barrier will be removed which will allow for competition. WaveMark, Inc can also enable the removal of barriers by releasing proprietary elements related to the hardware, firmware, software and technical training. This will allow for third-party vendors to compete on solicitations for WaveMark Solutions equipment maintenance, module and interface maintenance and user training

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Phuc Nguyen, PhD Date Biomedical Engineering

VAPAHCS

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Jill Williams Date Contracting Officer

NCO 21

PHUC

NGUYEN

Digitally signed by PHUC NGUYEN Date: 2025.08.12 08:18:32 -07'00'

JILL WILLIAMS

Digitally signed by JILL

WILLIAMS

Date: 2025.08.12 09:10:23 -07'00'

Effective Date: 11/15/24 Page 5 of 5

Acquisition ID#: 36C261-25-AP-2267

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Nick Kluch Date

Director of Contracting

NCO 21

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and open competition.

Curtis M. Jordan Date Executive Director Regional Procurement Office West Head of Contracting Activity (HCA)

NICHOLAS KLUCH Digitally signed by NICHOLAS KLUCH Date: 2025.08.14 08:23:15 -07'00'

CURTIS

JORDAN

Digitally signed by CURTIS

JORDAN

Date: 2025.08.17 16:46:19 -06'00'