SSJ_Redacted.pdf

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CLINITEK
Solicitation number
36C25025Q0807
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This document is a Single Source Justification (SSJ) for a simplified acquisition procedure from the Department of Veterans Affairs, specifically from Veterans Integrated Service Network (VISN) 10, Cleveland Veterans Affairs Medical Center. The Network Contracting Office (NCO) 10 intends to award a firm fixed-price, brand name purchase order to Siemens Healthlineers for a Clinitek urinalysis testing system. The justification highlights that Siemens is the only qualified vendor due to the system's unique capabilities, including automated urinalysis testing that reduces manual procedures, enhances testing accuracy, supports point-of-care testing across multiple clinics, and includes OEM-specific components critical for clinical workflow compatibility. Market research conducted across multiple platforms confirmed no alternative vendors could fulfill the requirement without significant operational disruptions, and no Service-Disabled Veteran-Owned Small Businesses (SDVOSB) or Veteran-Owned Small Businesses (VOSB) were identified as potential providers.

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VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 1 of 2 Acquisition ID# 36C250-25-AP-4672

DEPARTMENT OF VETERANS AFFAIRS

Justification for Single Source Awards IAW FAR 13.106-1 For

Over Micro-Purchase Threshold but Not Exceeding the SAT ($250K)

Acquisition Plan Action ID: 36C250-25-AP-4672

1. Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Service

Network (VISN) 10, Cleveland Veterans Affairs Medical Center (CLE VAMC) Network Contracting Office (NCO) 10.

Transaction: 5541-25-3-250-0310

2. Brief Description of Supplies/ Services required and the intended use/Estimated Amount:

Network Contracting Office (NCO) 10 intends to award a new, firm fixed price, brand name purchase order to Siemens Healthlineers for Clinitek.

ESTIMATED DOLLAR VALUE:

REQUIRED DELIVERY DATE: 90 Days ARO

3. Unique characteristics that limit availability to only one source, with the reason no other supplies or services can be used: Per FAR 11.105, "Items Peculiar to One Manufacturer," and FAR 12.302, "Tailoring of Provisions and Clauses for the Acquisition of Commercial Items," Siemens Healthlineers, the OEM, is uniquely qualified to provide the Clinitek Only based on the following:

Automates urinalysis testing, replacing manual procedures currently performed by nursing staff. This reduces reliance on human timing and color interpretation for test results.

Enhances testing accuracy and consistency, addressing issues that have previously led to failed proficiency testing and temporary loss of CAP accreditation.

Supports point-of-care testing across Wade Park and multiple Community- Based Outpatient Clinics (CBOCs), improving turnaround times and continuity of care.

Includes OEM-specific components such as reagent strips and quality control materials required for compatibility with existing clinical workflows.

Minimizes training disruptions and testing reinstatement delays that occur when manual testing fails accreditation standards.

VHAPG Part 813.106 Simplified Acquisition Procedures: Soliciting from a Single Source Attachment 1: Single Source Justification for SAP under the SAT

Revision: 01 Effective Date: 11/15/2024 Page 2 of 2 Acquisition ID# 36C250-25-AP-4672

4. Description of market research conducted and results or statement why it was not conducted:

The OEM, MSPV, DSBS, SAM.gov, National Contracts, Interagency Contract Directory, GSA, ECAT, SEWP, CM, BIC, FPDS and the Internet were reviewed with the following results: Only Sieman’s Heathlineers.

DSBS was reviewed with the following results: No SDVOSB/VOSB were identified.

Based on these findings, no alternative vendors were identified that could fulfill the need without significant facility modifications, procurement delays, or operational disruptions.

The VA and SBA rule of two cannot be met, there are no SDVOSB/VOSB or small business authorized distributors.

5. Contracting Officer's Certification: Purchase is approved in accordance with FAR13.106- 1(b). I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief. Per FAR 13.106-3(a)(2)(ii), price reasonableness will be based on comparison of proposed prices with prices found reasonable on previous purchases using

FPDS.

Rachelle J. Hamer Contracting Officer

NCO 10

RACHELL

E HAMER

Digitally signed by

RACHELLE HAMER

Date: 2025.07.30 16:30:09 -04'00'

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