JOFOC - Electrophoresis Testing - Final Redacted.pdf

VHAPG Part 806.3 OFOC Page 1 of 5 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C248-26-AP-1894

DEPARTMENT OF VETERANS AFFAIRS

REQUEST FOR RESTRICTING COMPETITION IN ACCORDANCE WITH FAR PART 12.102

UTILIZING SIMPLIFIED PROCEDURES

Acquisition Plan Action ID: 36C248-26-AP-1894

1. Contracting Activity: Department of Veterans Affairs (VA), Network Contracting

Office (NCO) 08, in support of Veterans Integrated Service Network (VISN) 08.

2237: 673-26-3-023-0038

2. Nature and/or Description of the Action Being Approved: This procurement is for Automated Capillary Protein Electrophoresis testing and reagents to be used on the Octa3 Analyzer systems in accordance with Revolutionary FAR Overhaul (RFO)

12.102 (b), utilizing procedures in RFO 12.201-1, Simplified Procedures (41 U.S.C.

1901). The Government anticipates a new sole source, single award, fixed price indefinite delivery/indefinite quantity (IDIQ) to Sebia, Inc (Sebia).

Electrophoresis Testing is assigned FSC 6640 and is not IT-related; therefore, FITARA does not apply to this procurement.

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

8 locations have a reoccurring need for continued laboratory services for electrophoresis testing. The Total Estimated Value of the proposed action is $4,091,294.00 for a five-year period ($818,258.80 / Yr). Any annual price difference will be a direct result of actual order quantities per site.

The VISN 08 contracting office proposes to procure by other than full and open competition for Electrophoresis Testing. Award will be a fixed-price Indefinite Delivery / Indefinite Quantity (IDIQ) sole source contract to Sebia with a Performance Period of April 1, 2026 – Mar 31, 2031.

Pricing Period 1: April 1, 2026 – March 31, 2027 ($818,258.80)

Pricing Period 2: April 1, 2027 – March 31, 2028 ($818,258.80)

Pricing Period 3: April 1, 2028 – March 31, 2029 ($818,258.80)

Pricing Period 4: April 1, 2029 – March 31, 2030 ($818,258.80)

Pricing Period 5: April 1, 2030 – March 31, 2031 ($818,258.80)

The procurement is for laboratory testing that separates molecules, primarily proteins or hemoglobin, in a blood sample. All locations require combinations of automated capillary serum and urine electrophoresis instruments, reagents, consumables, equipment services and maintenance. These tests are critical to the

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Acquisition ID#: 36C248-26-AP-1894 support of VA patient care and are only available from Sebia due to their proprietary nature. The equipment, labor, materials, and supplies to be covered under this IDIQ will support the VISN’s 38,600 total annual estimated molecular analyzer-based tests:

Test Description ORL VA SJ VA MIA VA WPB VA TPA VA Total Annual Estimates

Serum Protein (SPEP) 7822 2600 2000 1200 6000 19622 Serum/Urine Immunotyping (IT) 1201 400 750 600 3200 6151 Urine Protein (UPEP) 3077 1000 450 0 4700 9227 Hemoglobin (HBEP) 0 0 0 0 1200 1200 Carbohydrate Deficient Transferrin

(CDT) 0 0 0 0 100 100

Urine Immunofixation (UIFE) 0 0 0 0 1900 1900 Acid Hemoglobin (AHBEP) 0 0 0 0 300 300 Oligoclonal Bands, CSF 0 0 0 0 100 100 38600

4. Statutory Authority Permitting Other than Full and Open Competition: The statutory authority for applying the Simplified Procedures for Commercial Items is Revolutionary FAR Overhaul (RFO) 12.102 (b), utilizing procedures in RFO 12.201- 1, Simplified Procedures (41 U.S.C. 1901). 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 ( ) (2) Unusual and Compelling Urgency ( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services ( ) (4) International Agreement ( ) (5) Authorized or Required by Statute ( ) (6) National Security ( ) (7) 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): Sebia has patent and distribution rights for the specific analyzer and software in the U.S. and does not authorize alternative distributors. Substituting the Octa3 Analyzer with another analyzer would result in significant clinical and operational impact, as alternative platforms cannot perform the full electrophoresis assay menu nor access or trend historical PHORESIS data, which is essential for accurate longitudinal comparison of monoclonal proteins, hemoglobin variants, and other complex electrophoretic patterns. Loss of this historical continuity, combined with the need to revalidate an entirely new system, increases the risk of analytical variability, misclassification, diagnostic delay, and workflow disruption for VA clinical staff. Sebia provided a sole source declaration letter. Accordingly, Sebia Corporation

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Acquisition ID#: 36C248-26-AP-1894 is the only firm capable of providing the supplies described in Section III above without the Veteran’s Health Administration experiencing unacceptable delays in fulfilling its requirements

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as possible (including whether a notice was or will be publicized as required by RFO Part 5 and, if not, which exception under RFO Part 5 applies): A notice of intent to award a sole source procurement was posted to the System for Award Management (SAM), Contract Opportunities, under RFI 36C24826Q0291 on 01/29/2026. The notice stated that all responsible sources could submit a capability statement, proposal, or quotation, which the agency shall consider. Interested and capable contractors were to submit offers within fifteen (15) days of the notice’s publication. One response was received.

Helena Laboratories (Nexus Analyzer)

After the Program Manager evaluated the capability statements and brochures of the submitted equipment, it was determined Helena’s Nexus Analyzers did not provide evidence they could offer the Carbohydrate Deficient Transferrin (CDT) test/kit or the Oligoclonal Band (CSF) test/kit or whether they are cleared by the FDA. In addition, Helena did not confirm that the Nexus Analyzers were able to provide the software capable of producing patient historical graphing as indicated in the sole source notice.

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

Fair and Reasonable: In accordance with RFO 12.204(a), a fair and reasonable price will be based upon the comparison of previous pricing of similar analyzers and testing in the market provided by Sebia. Furthermore, comparison with procurement history and previous pricing may be adjusted to account for the number 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 was conducted by VISN 8 customer from 10/01/2025 to 12/1/2025 and by the contracting team from 01/15/2026 to 02/23/2026 via the Small Business Search (SBS) website, Contract Opportunities postings, and review of the Vendor Sole Source Declaration Letter.

Market Research was conducted to determine potential platforms for automated capillary protein electrophoresis systems. This is currently offered with the existing contract capable of performing and reporting the following assays: serum protein electrophoresis and serum immunotyping and urine protein electrophoresis and https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-5 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-5 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-5

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Acquisition ID#: 36C248-26-AP-1894 urine immunotyping. A search of the mandatory source, Ability One, revealed that they do not offer the requested testing services. A search in SBS using NAICS 334516 generated 342 SDVOSB / VOSB result, however Sebia does not use subcontractors to distribute products.

Sebia is the manufacturer and sole source for Octa3 Analyzers utilized in VA Clinic laboratories. As verified, there are no authorized SDVOSB / VOSB’s that can perform maintenance, repairs or distribute product consumables and reagents.

Sebia was contacted to inquire if they had any authorized distributors who could also sell the requested CRC consumables. The OEM responded that they are the sole proprietary manufacturer and domestic distributor in the US. The Buy American Act does not apply to this acquisition, as the analyzers are made in America by Sebia, Inc.

Market research confirms there are no authorized SDVOSBs/VOSBs or Small Businesses to perform maintenance or distribute product. It is in the best interest of the government to award an unrestricted sole source procurement directly to the OEM, Sebia, a Large Business.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

The software used at the laboratories to analyze patient history is provided as part of the Octa3 analyzer platform. The graphing software is proprietary to Sebia and designed for use with Octa3 analyzers.

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

Helena Laboratories

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: Currently, the only vendor capable of providing all electrophoresis tests and graphing software for historical patient results is Sebia. The testing must be analyzed using instrumentation already located in the laboratory through a current contract for continuity of patient graphing results. The inability to acquire other analyzers that would be compatible with the current analyzers would force all medical centers within VISN 8 to procure replacement analyzers at a significantly higher cost and cause irregularities in the electrophoresis testing. Every effort will be made in future requirements to identify vendors who can provide the assays and graphing software.

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

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Acquisition ID#: 36C248-26-AP-1894

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.

Lizbeth Ruiz-Torres Date Supervisory Clinical Laboratory Scientist

Pathology & Laboratory Medicine Service

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

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

Todd Pappas Date 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.

Paul Jarret Date Senior Contracting Officer

North VISN Team

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $90 million) or approve ($900K to $90 million) for other than full and open competition.

Gerald F. Jacobs Date

Head of Contracting Activity, East https://dvagov.sharepoint.com/sites/vhapromanual/SitePages/VHAPM-Part-806.3.aspx