P03-JOFOC-2.19.25_Redacted.pdf

Effective Date: 11/01/24 Page 1 of 4

REVISION: 01

Acquisition ID#: 36C261-25-AP-0095

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261-25-AP-0095 JOFOC Tracker FY25: FY25-NCO21-226

1. Contracting Activity:

Department of Veterans Affairs (VA), Regional Procurement Office West (RPOW), Network Contracting Office (NCO) 21, on behalf of the Veterans Integrated Service Networks (VISN) 21, VA Northern California Healthcare System (VANCHCS).

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

This procurement is for for UDI Tracker and Recall Connect Electronic Implant Tracking System, and it will be a new firm-fixed-price sole source contract to the Original Equipment Manufacturer (OEM), the Champion Medical Technologies, Inc. (Champion) Doing Business As InVita Healthcare Technologies. VANCHCS) has a requirement for medical implant tracking system 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.

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

VANCHCS requires the continued use of the Champion Medical technologies, Inc. (Champion) UDI Tracker and Recall Connect Electronic Implant Tracking system that is currently installed for continuity of care for future, current, and past surgical implant cases.

Champion UDI Tracker and Recall Connect software meets 100 percent of the requirements of VANCHCS and it meets all of Joint Commission on Accreditation of Healthcare Organizations (JCAHO) accreditation requirements. UDI Tracker and Recall Connect software holds all of a patient’s medical history following the last visit for 75 years and is available for immediate use whenever it is needed.

This ensures constant, uninterrupted access to patients’ medical histories which helps ensure that there is a continuity of care. Current and future versions of UDI Tracker and Recall Connect software will be backwards compatible.

UDI Tracker also incorporates Recall Connect software. Recall Connect software is the only known system that gleans its sources from the National Center for Patient Safety (NCPS). This is the very same source from which the VA gets its alerts. This creates a beneficial redundancy that ensures that a recall can never be missed. The electronic review and hold feature (Recall Connect) stops use of any implant that has been recalled, as soon as it is identified; immediately flagged, and will not allow the flagged item through to run through any other parties, systems, and or parts of the UDI Tracker software - flagging it as a recalled item with immediate attention needed.

Effective Date: 11/01/24 Page 2 of 4

Acquisition ID#: 36C261-25-AP-0095

UDI Tracker and Recall Connect have been used to document biologic implant use at this VA facility since October 2016. Innumerable hours have been spent completing the identification of clinics, staff, procedures, and implants used in each modality. Furthermore, policies, procedures, and protocols have been created to support this system. Frontloading of data has already been completed and medical staff are already onboard with current policy, protocols, and procedures.

FAR clause 52.217-8, Option to Extend Services will be used if needed to ensure there is no interruption in services to veterans.

Base Year (One Time Fee)

Base Year

Period of Performance

02/01/2025 – 09/30/2025

Option Year 1

Period of Performance

10/01/2025 – 09/30/2026

Option Year 2

Period of Performance

10/01/2026 – 09/30/2027

Option Year 3

Performance

10/01/2027 – 09/30/2028

Option Year 4

Performance

10/01/2028 – 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 ( ) 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):

Effective Date: 11/01/24 Page 3 of 4

This UDI Tracker and Recall Connect Software works directly with the InVita Tissue and Implant Tracking System that is already installed and operational at VANCHCS Health Care Facilities. Their tracker automates tissue and implant tracking processes. Further, recalled or expired items are electronically monitored and recall management is expedited immediately which increases patient safety. This procurement is for the permissions/licenses to continue to legally use the UDl Tracker software already in use at five VA locations.

If we switch to a new vendor for the same services, we will have to pay extra implementation fees to the new vendor to initiate the process again.

An electronic tracking process is mandatory as required by JCAHO, FDA, and VA Directive 1081.02, “Management of Biological and Non-Biological Implants.” Without the continued relationship with our current vendor, patient care would be adversely impacted based on the information above.

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

A Notice of Intent to Sole Source and the Solicitation will be publicized on Contract Opportunities, with an open date of November 06, 2024 and a close date of November 09, 2024.

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

The CO will determine that the final contract price will be fair and reasonable by comparing the quoted prices to historical procurement data.

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

Market Research Was Not Conducted:

A Dynamic Small Business Search of 541511 yielded _0_ SB firms nationwide.

A search of the Veteran Certification database utilizing NAICS 541511 (Custom Computer Programming Services) resulted in 4151 Small Disabled Veteran Owned Small Business (SDVOSB) and Veteran Owned Small Business (VOSB) operating in that North American Industry Classification System (NAICS).

FPDS.GOV search indicated that contract was awarded to Champion, 36C26121P1249, 07/07/2021.

Champion is the incumbent vendor that is currently providing patient implant tracking software, UDITracker to document biologic implant use in veterans at VA Northern California Health Care Systems (VANCHCS). VANCHCS requires the continuation of the Champion UDI Tracker and Recall Connect Electronic Implant Tracking system that is currently installed for continuity of care for future, current, and past surgical implant cases.

There was only one response to the notice of Intent received, it was from Jorden McDonald LLC.

Effective Date: 11/01/24 Page 4 of 4

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:

Champion D/B/A InVita Healthcare Technologies (OEM)

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:

The agency will continue to conduct market research for future acquisitions of the same or similar Items.

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

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.

DATE

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.