Justification - Redacted.docx

FAR Part 12 Acquisition of Commercial Products and Commercial Services Attachment 1: Request for Sole Source Justification >SAT-$9M under FAR12

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL ITEMS IN ACCORDANCE WITH FAR 12

Acquisition Plan Action ID: 36C248-26-AP-0194

1. Contracting Activity: Department of Veterans Affairs, VISN 8, James A. Haley Veterans Hospital (JAHVH), Bay Pines (VAMC)

Reference obligation# (2237) 673-26-2-023-0016, 516-26-2-033-0016.

2. Nature and/or Description of the Action Being Processed: The VISN 08 contracting activity proposes to procure by other than full and open competition for Erythrocyte Sedimentation Rate (ESR) Testing. Award will be a fixed-price contract consisting of a base year with four (4), one (1) year options.

This ESR CPT procurement is not IT-related; therefore, FITARA does not apply to this procurement.

FAR12 Acquisition of Commercial Products and Commercial Services: This procurement is Erythrocyte Sedimentation Rate (ESR) Testing in accordance with FAR 12 Acquisition of Commercial Products and Commercial Services and specifically FAR 12.201-1 Simplified Procedures, 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 6.103-1.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: The Contractor shall provide a Cost-Per-Test (CPT) fully automated Erythrocyte Sedimentation Rate (ESR) Testing within VISN 8, Department of Pathology and Laboratory Medicine Service (P&LMS). P&LMS requires equipment in at least two (2) healthcare systems, for the Tampa VA Healthcare Network (TVAHCN) and Bay Pines VA Healthcare System (BPVAHCS). Testing is currently conducted at five (5) locations, with the flexibility to expand and add instrumentation at additional VISN 8 sites as needed to meet future demand.

Current locations:

Tampa VA Healthcare Network, James A. Haley Veterans Hospital (JAHVH) 13000 Bruce B. Downs Blvd., Tampa, Florida 33612

Tampa VA Healthcare Network, New Port Richey VA Outpatient Clinic (NPROPC) 7900 Little Road, New Port Richey, Florida 34654

Tampa VA Healthcare Network, Lakeland Community-Based Outpatient Clinic (LCBOC) 2080 Meadowland Park Blvd, Lakeland, Florida 33803

Bay Pines VA Healthcare System, C.W. Bill Young VA Medical Center (CWBY VAMC) 10,000 Bay Pines Blvd, Bay Pines, Florida 33744

Bay Pines VA Healthcare System, Lee County VA Healthcare Center (LCHCC), 2489 Diplomat Parkway East, Cape Coral, Florida 33909

VISN 8 purchased the ALCOR iSED Pro Analyzer equipment as capital during the clinic opening and has been using the system over 10 years. Reagents to perform patient testing are currently purchased as needed using a credit card. There is no active contract for reagents and/or service of the testing equipment. The VA is wanting to purchase new equipment, reagents and the maintenance/repair.

Total Contract Value is estimated at $722,300.00.

Award is estimated to be in place by 01/01/2026 with a 4-month mobilization period to exchange the equipment.

Base Year: April 1, 2026 thru March 31, 2027 estimated at $245,260.00 Option One: April 1, 2027 thru March 31, 2028 estimated at $119,260.00 Option Two: April 1, 2028 thru March 31, 2029 estimated at $119,260.00 Option Three: April 1, 2029 thru March31, 2030 estimated at $119,260.00 Option Four: April 1, 2030 thru March 31, 2031 estimated at $119,260.00

4. Statutory Authority Permitting Restricted Competition:

FAR 12 Acquisition of Commercial Products and Commercial Services. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 12 is 41 U.S.C. § 1901 and is implemented by FAR 12.201-1 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): Alcor Scientific Inc is the manufacturer of the iSED Pro Analyzer and the only source that can provide the required specifications described in section 3 above and in the Statement of Work without the Veterans Health Administration incurring substantial duplication of cost that could not be expected to be recovered through competition and cause an unduly delay in patient support.

Contractor provided a sole source declaration statement.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: A Sources Sought (36C24826Q0057) was posted to Contracting Opportunities 10/24/2025 – 10/31/2025 for an analyzer that would meet the following criteria:

The potential analyzer must have, at minimum, the following specifications:

- Must have at least a 24-hour room temperature specimen stability

- Must have an onboard sample capacity of at least 100 specimens

- Must have a specimen throughput of at least 175 samples per hour

- Must have a reportable range of 1-130 mm/hour

Two capability responses were received from the following firms:

Sysmex America Inc (Alifax ESR Analyzer) Mechatronics USA LLC (Starrsed NSTA Analyzer)

However, based on the submitted product brochure specifications, the Program Manager’s evaluation of the proposed equipment determined neither company submitted analyzers that were able to provide the required specifications as described above.

Below is a comparison of the required specifications and the proposed analyzers:

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: A fair and reasonable price will be based upon the comparison of previous pricing of similar analyzers and testing in the market provided by Alcor Scientific. Furthermore, comparison with procurement history and previous pricing may be adjusted to account for the amount of tests / locations.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted: Market research conducted via SBA VetCert and DSBS websites and Vendor Declaration Letter. Alcor Scientific is the manufacture and service license holder of the ESR analyzer currently utilized in VA Clinic laboratories. As verified by Bredan Feeney, there are no authorized SDVOSB / VOSB’s can perform maintenance / repairs or distribute product / reagents.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: In addition to the lack of product specifications indicated above in section 6, the lab has very limited refrigerated specimen storage. All EDTA specimen tubes are stored at room temperature up to 48 hours. It is critical that the ESR analyzer is able to use a specimen which has been stored at room temperature for at least 24 hours to prevent patient care delays. Approximately 2-4 sedimention rate orders are reflexed by provider following the review of other lab test results. In almost all cases, that reflex order is greater than 6 hours from time of specimen collection. Specimens are collected at the remote clinics. Transportation to a laboratory with ESR analyzers may be greater than 6 hours from time of collection. In the event specimens are not refrigerated or tested within 6 hours, patients would need to be called back to the facility for recollections. This affects patient care and customer service. Patients are required to undergo a second phlebotomy procedure for the collection of a second specimen. This is added time, resources, and consumables.

Alcor Scientific is the only vendor that can provide VISN 8 with ESR Analyzer capable of providing accurate testing for specimens with 24 hr room temperature stability.

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

Sysmex America Mechatronics USA

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 Contracting activity will continue to encourage brand name or equivalent specifications. We will continue to monitor new analyzer products introduced in lab testing in order to identify systems that may meet our specialized needs at a lower cost. A sole source award justification will be posted for this acquisition.

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.

Medical Technologist Path & Lab Bay Pines

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 North VISN Team

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $900k): I certify the justification meets requirements for other than full and open competition.

Senior Contracting Officer North VISN Team

Effective Date: 11/15/24 Page 1 of 9

REVISION: 01

Acquisition ID#: 36C248-26-AP-0194