P03 - Brand Name Only.pdf

Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 3 Revision: 03 Effective Date: 04/15/24 Acquisition ID#: __________________

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C262-24-AP-3295

1. Contracting Activity: Department of Veterans Affairs, NCO 22, Supply 4 in support of VISN 22, Tucson Medical Center. 2237# is 678-24-2-071-0082.

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

This procurement is for the purchase and installation of a complete system to store and track biological tissues used during surgical procedures. The system must include RAIN RFID-enabled 6 - 25 cu. ft. Large intelligent Cabinets, tissue tracking software package to comply with FDA requirements for storage of implantable biologics. This requirement will be awarded as a new contract. The Government anticipates the award of a firm-fixed price option year contract to include a base year and four (4) option years. The Government anticipates awarding this contract to one vendor.

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

TrackCore provides VA approved software that is specifically designed to help track implants bidirectionally throughout the hospital and satisfy the FDA/Joint Commission regulatory guidelines.

TrackCore is 100% FDA/Joint Commission compliant, integrates with the National Recall Alert Center. The VA, TrackCore and Cerner have officially partnered for the upcoming EHR Implementation at all VA Medical Centers. This is the VA’s sole Tissue Tracking integration partner for Cerner. TrackCore’s software will be hosted in the Cerner Enclave, which is the future standard for all VA and DoD facilities. TrackCore is in line with standardization requirements for the VA.

4. Statutory Authority Permitting Other than Full and Open 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) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by FAR 6.302-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by FAR 6.302-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by FAR 6.302-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by FAR 6.302-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by FAR 6.302-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by FAR 6.302-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by FAR 6.302-7;

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 TrackCore system has been approved by VACO and will be the only company that we (the VA) will use to work with our new and existing EHR Implementation at all VA Medical Centers. Cerner Tissue Tracking integration partner for the VA is this one and only. The Cerner Enclave, the future norm for all VA and DoD sites, will host TrackCore's software. TrackCore complies with the VA's

VHAPG Part 806.3 OFOC Page 2 of 3

Acquisition ID#: __________________ standards requirements. The exclusive nature of the software means that only one vendor can produce these particular tissue monitoring systems, according to market research. Since VA is in the process of standardizing Tissue Tracking systems across the VA network, it would be prohibitively expensive to replace the current infrastructure and would cause unacceptable delays if a different vendor was selected for this requirement.

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

Market research including publishing source sought notice on SAM.gov returned a single SDVOSB distributor who performed similar acquisition in the past as sole authorized distributor of the manufacturer.

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

Reasonable:

Since the Government will award this contract on a BRAND NAME ONLY basis, the price fair and reasonable determination will be based on the following:

• Comparison with the Independent Government Cost Estimate

• Comparison of proposed pricing on similar awards.

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

Market Research Was Not Conducted:

Market research was conducted and several vendors were found to be able to meet the VA’s need for this requirement. However, because the TrackCore system has been approved by VACO and will be the only company that we (the VA) will use to work with existing RFID cabinets and new EHR Implementation at all VA Medical Centers, these alternate providers were not considered.

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:

Four Points Technology, L.L.C.

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:

N/A.

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.

Anna Malone Date Surgical Services Business Manager Southern Arizona VAHCS

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

https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM/VHAPM_Part_806.3.aspx

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Acquisition ID#: __________________

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

Peter Kim Date Contracting Officer

NCO22