P03 36C242-23-AP-2436 Final.pdf

Effective Date: 02/01/2022 Page 1 of 4

36C242-23-AP-2436

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN

COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C242-23-AP_2436_

1. Contracting Activity: Department of Veterans Affairs, VISN 02 Network, New York Harbor Healthcare System (NYHHCS), Manhattan Campus, 423 East 23rd Street, New York, NY 10010 has submitted a purchase request #630-24-1-4307-0001 to the Department of Veterans Affairs, Network Contracting Officer (NCO) 2, 2875 Union Road Suite 3500, Cheektowaga, NY 14227.

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

This is a request for approval of a new firm-fixed priced, sole source, recurring maintenance support service purchase order, for the WaveMark Inventory Management System. This system manages the inventory of supplies expended in specialty procedures in the Manhattan Cath Lab and the Manhattan Hybrid OR. This procurement will be a follow-on purchase order to 36C24223P0010, which ends 09/30/2023. The anticipated period of performance of 10/01/2023 – 09/30/2024 with the provision of four (4) priced option years. The base cost is $220,592.00 and the total estimated cost is $1,102,960.00

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

The NYHHCS Manhattan Campus located at 423 East 23rd Street, New York, NY 10010 requires a service maintenance agreement for the WaveMark Inventory Management System currently in use in the Cath Lab and the Hybrid OR. This agreement shall provide; equipment maintenance, license maintenance, and support services. The contractor shall be responsible for full maintenance coverage by providing all replacement parts, labor, travel expenses, tools, and other incidentals necessary to maintain the listed equipment to the OEM operating specifications throughout the term of the contract.

This equipment is installed at the following sites:

NYHHCS VA Medical Center 12th floor – Cath Lab 6th floor- Hybrid Operating Room 423 East 23rd Street New York, NY 10010

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

Effective Date: 02/01/2022 Page 2 of 4

( ) 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):

WaveMark Inc. a Cardinal Health Inc. company is the only company that can provide all the necessary certified technicians and OEM parts to perform all the OEM recommended maintenance for the WaveMark Inventory Management System, due to patents and copyrights on this equipment and supporting software. These patents and copyrights prevent other possible contractors from accessing the diagnostic proprietary software, possessing necessary tooling or providing OEM parts to the Government. These maintenance services are considered “highly specialized” and thus there is only one responsible source, per FAR 6.302-1.

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

This requirement is currently procured under purchase order 36C24223P0010 for the Manhattan VA Medical Center with the large business (LB) , original equipment manufacturer (OEM) WaveMark Inc. a Cardinal Health Inc. company. Due to the proprietary software, WaveMark Inc. a Cardinal Health Inc. company is the only authorized company able to perform service maintenance on the WaveMark Inventory Management System, as well as the only company with access to manuals and design specifications of its inventory management system. A search of VetBiz, SBA, GSA, NAC and Google websites were used to determine if any other vendors could perform all the requirements of the Statement of Work and are further documented in Section 8. A Notice of Intent to Sole Source was published on SAM.gov from June 13, 2023 - June 26, 2023 seeking any company capable of performing this service maintenance. No vendors responded. Since WaveMark Inc. a Cardinal Health Inc. company is already performing these services, they were determined to be the only company capable of performing services on this highly specialized equipment.

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

The anticipate cost to the Government is considered fair and reasonable based on the IGCE, past contract pricing and quoted pricing for this service agreement, that comes directly from the manufacturer; WaveMark Inc. a Cardinal Health Inc. company and provides for discounts to the Government.

Price reasonableness shall be determined through comparing the received quotes to the previous procurement of this requirement; 36C24223P0010 for the period of 10/01/2022-09/30/2023 for the price of $194,100.00 and list prices to the public. While the current quote is 14% higher, the price to the public is 20% higher. Pricing remains unchanged for the life of the contract. The pricing has been determined to be fair and reasonable based on comparison to the previous pricing and the

IGCE.

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

Market research, in accordance with FAR Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition and soliciting inquiries from interested parties and the following was found:

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A search of the VIP database A search of VIP using the NAICS code 541513 and keyword “WaveMark” did not identify any SDVOSB nor VOSB that may be capable of performing the requirements of this procurement.

A search of GSA eLibrary using the keywords “WaveMark” did not return any results. A second search using “Cardinal Health” (parent company) only yielded results for medical supplies on various schedules.

A search of SBA Quick Market Search and using the keywords ”WaveMark” returned no small business vendors that could possibly meet the requirements of this procurement.

A search of National Acquisition Center (NAC) Med Surg catalog utilizing the keyword “Cardinal Health” returned multiple supply schedules only.

A Google search using the keywords” WaveMark service” only returned Cardinal Health, WaveMark or the VA OIT.

A Notice of Intent to Sole Source was 36C23223Q0841 was posted on SAM.gov from June 13, 2023- June 26, 2023 seeking information from contractors who could potentially provide the required service maintenance and received no replies of any interested parties. No response was required from WaveMark Inc. a Cardinal Health Inc. company as the OEM is already performing services at the Manhattan VAMC under the current contract.

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

WaveMark Inc. a Cardinal Health Inc. company is the sole manufacturer, distributor of parts and service provider of the Inventory Management System. No third-party service providers are authorized. WaveMark Inc. a Cardinal Health Inc. company as OEM, holds all the patents, copyrights and proprietary software and the only company to show written interest in this procurement.

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

OEM LB, WaveMark Inc. a Cardinal Health Inc. company.

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:

In situations involving complex medical equipment, it is difficult to remove barriers to competition due to the OEM being the only qualified company capable of providing service maintenance to their own specialized equipment. When proprietary software, specialized tooling and patented electronics are part of the service maintenance, providing OEM service is not possible, to an outside vendor unless the OEM allows others to be trained to perform OEM service and access proprietary software. Currently only WaveMark Inc. a Cardinal Health Inc. company can provide service maintenance. An alternative to remove barriers would be replace the existing inventory supply system, but even then, another vendor may have the same OEM restrictions. The NYHHCS is satisfied with the performance of the WaveMark Inventory System and does not wish to replace this equipment until the end of its equipment life cycle. Having a service maintenance agreement will be properly maintained the equipment for the duration of this contract.

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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.

Diana Virland Biomedical Engineer Date Manhattan VAMC

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.

Charnell Cunningham Date Contracting Officer

NCO 2

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.

Janine Childs Date NCO 2 Branch Chief Services Team II

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.

Joseph P. Maletta Date VHA Head of Contracting Activity (HCA)

CHARNELL

CUNNINGHAM

173142

Digitally signed by CHARNELL

CUNNINGHAM 173142

Date: 2023.07.05 09:18:00 -04'00'

DIANA VIRLAND Digitally signed by DIANA VIRLAND Date: 2023.07.11 11:02:08 -04'00'

JANINE

CHILDS

Digitally signed by

JANINE CHILDS

Date: 2023.07.13 07:30:21 -04'00'