Justification 36C261-24-AP-3293_Redacted.pdf

Effective Date: 02/01/2022 Page 1 of 3

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261-24-AP-3293 JOFOC Tracker 24: FY24-NCO21-1931

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Network Contracting Office (NCO) 21, located at Palo Alto, CA, in support of VA Palo Alto HealthCare System (VAPAHCS) at 3801 Miranda Avenue Palo Alto, CA 94304-1207 2237:

2. Nature and/or Description of the Action Being Processed: This procurement is for preventative maintenance (PM) and technical support service in support of a lease for a Walk-Away Automated Specimen Processing (WASP) Instrument 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.

The nature of this action is to request approval to procure services from COPAN Diagnostics, Inc as a sole source, open market action. This a new requirement that will be awarded under a firm-fixed-price contract.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Pathology & Laboratory Medicine Service Department within the VAPAHCS has a requirement for preventative maintenance (PM) and technical support service in support of a lease for a Walk-Away Automated Specimen Processing (WASP) Instrument. The proposed contract action consists of a one-year base period with four (4), one (1) year option periods to extend the period of performance IAW FAR 52.217-9.

The period of performance and estimated costs are:

Contract Period Period of Performance Estimated Cost Base Year 10/1/2024-09/30/2025 Option Year 1 10/1/2025-09/30/2026 Option Year 2 10/1/2026-09/30/2027 Option Year 3 10/1/2027-09/30/2028 Option Year 4 10/1/2028-09/30/2029

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

Effective Date: 02/01/2022 Page 2 of 3

( ) 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): The VAPAHCS has an ongoing need for a microbiology lab processing instument to analyze specimens. The instrument automates the historically manual process of inoculating various lab growth media with samples of patient fluids. The instrument currently in use within the VAPAHCS facility is the COPAN WASP, which is manufactuered by COPAN Diagnostics, Inc. COPAN Diagnostics, Inc has multiple distributors for the WASP instrument but they are exclusively be serviced by the manufacturer.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted, details of which are in section 8 of this document. This effort did not yield any additional sources that could meet the Government's requirements. There is no competition anticipated for this acquisition.

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

Reasonable: IAW FAR 13.106-3(a)(2), the anticipated cost to the Government will be considered fair and reasonable by comparing the proposed pricing to the independent government cost estimate (IGCE) and previous purchases.

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

Market Research Was Not Conducted: As described in Section 6 above, market research, in accordance with FAR Part 10, was conducted by reviewing the contract number 36C26119F0373, in which the original WASP lease with PM and technical support service were acquired. The action was competed as full and open competition under FAR Part 8. The contract was awarded to Biomeriux Inc as a delivery order against their GSA contract number GS-07F-9525S. Under contract number 36C26119F0373 Biomeriux Inc supplied the lease for the COPAN WASP while the PM and corrective maintenance service of the WASP was supplied by COPAN Diagnostics, Inc.

A search of FPDS for the keyword “WASP” between the dates of June 7, 2022 – June 7, 2024 yielded 15 contract actions made by the VA. Two of the actions were for WASP leases and seven were for preventative and corrective maintenance services. The remaining six actions were modification actions. Five of the actions for preventative and corrective maintenance services were awarded to COPAN Diagnostics, Inc, one was to Beckman Coulter Inc and the other to Biomeriux Inc. The five actions awarded to COPAN Diagnostics, Inc 36C25523P0775, 36C25924P0281, 36C26322P0695, 36C24720C0064 were sole source purchase orders and 36C25522P0654 was a competed purchase order.

A search of the SBA’s VetCert database utilizing NAICS code 811210 yielded 241 possible SDVOSBs/VOSBs. No further efforts were made to identify additional SDVOSBs/VOSBs due to the unique nature of the acquisition.

The Buy American Statute does not apply to the acquisition of services.

This procurement does not require compliance with the Federal Information Technology Acquisition Reform Act (FITARA), as it is not information technology or operation management related.

Effective Date: 02/01/2022 Page 3 of 3

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

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

COPAN Diagnostics, Inc, 26055 Jefferson Ave, Murrieta, CA 92562-6983

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 order to remove or overcome barriers to competition in future acquisitions for this requirement, VA will continue to conduct additional market research in order to identify other microbiology lab processing instruments that can meet the agency’s needs or the ability of other vendors to service the current microbiology lab processing instrument.

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.

Date

Laboratory Manager VAPAHCS, Pathology & Laboratory Medicine Service

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.

Contracting Officer Network Contracting Office 21

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.

Branch Chief, Supply Team 1

Network Contracting Office 21