P03-556-26-2-2993-0107 Ultrasound signed.pdf

Attachment 1: Request for SDVOSB/VOSB Sole Source Justification Format IAW VAAR 819.7008/9

VHAPG Part 819.7008/7009 Sole Source Awards to SDVOSB/VOSB Page 1 of 4 Revision: 05 Effective Date: 12/15/2025

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition

Acquisition Plan Action ID: 36C252-26-AP-1868

1. Contracting Activity: Department of Veterans Affairs, VISN 12, Captain James A. Lovell Federal Health

Care Center has submitted 556-26-2-2993-0107 for Ultrasound System Upgrade to the Great Lakes Acquisition Center (NCO12).

2. Nature and/or Description of the Action Being Approved: This justification is for the Ultrasound Sherlock 3CG+ Tip Confirmation System needed for the Captain James A. Lovell Federal Health Care Center.

Estimated Amount: $80,338.00

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

The required Sherlock 3CG+Tip Confirmation System (TCS) utilizes advanced ECG technology to confirm BARD PICC tip placement at the cavo-atrial junction with a high degree of accuracy and patient safety. The unique characteristics that limit availability to only this system are as follows:

The Sherlock 3CG+ TCS is the only system that provides real-time, ECG-based confirmation of peripherally inserted central catheter (PICC) tip placement specifically compatible with the BARD PICCs used by the Vascular Access team at the James Lovell VA facility. The 3CG+ technology is proprietary to BD and integrates with the BARD PICC lines currently in regular use, ensuring compatibility and seamless workflow for VA clinical staff.

Alternative tip confirmation methods or technologies either are not compatible with BARD PICCs or do not offer ECG-based, real-time tip confirmation, which is essential for reducing malposition rates and avoiding post-placement chest X-rays, thus improving patient safety and clinical efficiency.

The Sherlock 3CG+ TCS is only available in conjunction with the BD Site Rite 9 Ultrasound system, as no other ultrasound platform supports this ECG-based TCS integration.

Comprehensive market research confirmed that:

No other manufacturer or product offers a tip confirmation system with these capabilities and with verified compatibility for BARD PICCs utilized at this VA facility.

The use of any other system would require a facility-wide change from BARD to another PICC line vendor, resulting in substantial additional cost, risk of workflow disruption, and retraining needs.

Therefore, only the Sherlock 3CG+Tip Confirmation System, used with the BD Site Rite 9 Ultrasound, meets the VA’s critical requirements for ECG-based PICC tip confirmation and is essential for ongoing patient care and safety at the James Lovell VA.

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4. Statutory Authority Permitting Other than Full and Open Competition: 41 USC §3304(a)(5), 38 U.S.

Code § 8127(c), as implemented by RFO 6.103-5 (Authorized or Required by Statute). COs may use the non-competitive (sole source) procedures authorized in VAAR 819.7008 (DEVIATION) or VAAR

819.7009 (DEVIATION)- up to $5,000,000. Check the specific VAAR clause used below:

(x) 819.7008 Sole source awards to a certified service-disabled veteran-owned small business; or ( ) 819.7009 Sole source awards to a certified veteran-owned small business

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

The hospital currently uses the BARD Power PICC Catheter system that is only compatible with the SiteRite 9 sherlock system.

The SiteRite 9 uses ECG technology to confirm BARD PICC tip placement at the cavo-atrial junction.

This 3CG+ technology is the only compatible system with the BARD PICCs utilized from the Vascular Access team at the hospital. Both the Power PICC catheters and the SiteRite 9 system are part of BD’s vascular access product line, designed to work as an integrated system. This ensures seamless interaction between catheter placement tools and imaging/confirmation systems. SiteRite 9 incorporates Cue Needle Tracking, providing real-time visualization of needle advancement. This feature ensures safer and more precise vascular access when placing BARD PICCs.

The Contract Specialist contacted the Original Equipment Manufacturer (OEM) to inquire about vendors authorized to distribute their products to the Department of Veterans Affairs. The OEM confirmed that they have a single authorized vendor Veterans Healthcare Supply Solutions. Veterans Healthcare Supply Solutions is a Service-Disabled Veteran-Owned Small Business (SDVOSB).

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable, including whether a notice was or will be publicized as required by RFO 6.301 and, if not, which exemption under RFO 5.101(b)(1) applies:

This procurement is valued below the simplified acquisition threshold

The hospital currently uses the BARD Power PICC Catheter system that is only compatible with the SiteRite 9 sherlock system.

The SiteRite 9 uses ECG technology to confirm BARD PICC tip placement at the cavo-atrial junction.

This 3CG+ technology is the only compatible system with the BARD PICCs utilized by the Vascular Access team at the hospital. Both the PowerPICC catheters and the SiteRite 9 system are part of BD’s vascular access product line, designed to work as an integrated system. This ensures seamless interaction between catheter placement tools and imaging/confirmation systems. SiteRite 9 incorporates Cue Needle Tracking, providing real-time visualization of needle advancement. This feature ensures safer and more precise vascular access when placing BARD PICCs.

The Contract Specialist contacted the Original Equipment Manufacturer (OEM) to inquire about vendors authorized to distribute their products to the Department of Veterans Affairs. The OEM confirmed that they have a single authorized vendor Veterans Healthcare Supply Solutions.

Veterans’ Healthcare Supply Solutions is a Service-Disabled Veteran-Owned Small Business

(SDVOSB).

https://www.va.gov/oal/library/vaar/vaar819.asp#8197008 https://www.va.gov/oal/library/vaar/vaar819.asp#8197009 https://www.va.gov/oal/library/vaar/vaar819.asp#8197009 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-6#FAR_6_301 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-5#FAR_5_101

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Market research confirms that Veterans Healthcare Supply Solutions is the only known SDVOSB that meets all capability criteria necessary for this effort. Thus, competitive solicitation would not result in a more advantageous outcome for the VA or its stakeholders.

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

Reasonable:

The SiteRite 9 Ultrasound System with components is considered reasonably priced, as evidenced by the utilization of previous contracts with similar pricing structures. The current costs for SiteRite 9 Ultrasound System remain consistent with industry benchmarks. These contracts demonstrate that the VA has historically secured SiteRite 9 Ultrasound Systems at comparable price points, ensuring cost-effectiveness and fiscal responsibility. Leveraging these prior contracts allows the VA to confidently validate the price reasonableness of the SiteRite 9 Ultrasound System, maintaining alignment with market standards and optimizing value for the agency.

Contracts For reference of price reasonableness.

VETERANS HEALTHCARE SUPPLY SOLUTIONS, INC: 36C26126P0624 ($90,713.54)

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

A search of the SBA web page using NAICS code 334510 and narrowing it down to SDVOSB and VOSB came up with 455 vendors.

A search of the SBA web page using NAICS code 334510 and key words Ultrasound System resulted in 0 SDVOSB/VOSB vendors.

The Contract Specialist contacted the Original Equipment Manufacturer (OEM) to inquire about the availability of small business vendors authorized to distribute their equipment. The OEM responded that they have one authorized Small Business vendor for their products: Veterans Healthcare Supply Solutions (SDVOSB).

9. 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.

Name Date Title Facility

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10. 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.

Name Date Title Facility https://dvagov.sharepoint.com/sites/vhapromanual/SitePages/VHAPM-Part-806.3.aspx