J066-- STX Richard-Allan Epredia SVC

DEPARTMENT OF VETERANS AFFAIRS Veterans Health Administration Network Contracting Office 17 (NCO 17) | Lab Services Support (LSS) 5441 Babcock Rd., Suite 302, San Antonio, TX 78240 JUSTIFICATION AND APPROVAL (J&A) FOR OTHER THAN FULL AND OPEN COMPETITION In Accordance with FAR Subpart 6.3 and RFO FAR Part 6 Authority: 41 U.S.C. § 3304(a)(1) | FAR 6.302-1(a)(1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements Requirement Title: STX Richard-Allan Epredia Preventive Maintenance and Repair Services Acquisition Plan Action ID: 36C257-26-AP-4177 Purchase Request No.: 671-26-4-121-0661 JOFOC Log Number: FY26 - NCO 17 - 1828 Date Prepared: July 20, 2026 Contracting Activity: Department of Veterans Affairs, Veterans Health Administration Contracting Office: RPO West | Network Contracting Office 17 (NCO 17) | Lab Services Support (LSS) NAICS Code: 811210 Electronic and Precision Equipment Repair and Maintenance PSC Code: J066 Maintenance/Repair/Rebuild of Equipment: Industrial and Manufacturing Machinery Contract Type: Firm-Fixed-Price (FFP) | Commercial Service | FAR Part 12 Proposed Contractor: Richard-Allan Scientific, LLC. (d/b/a Epredia) UEI / CAGE: N1LPLL6K6S58 / 044N0 Period of Performance: Base Year: August 1, 2026 July 31, 2027, plus Four (4) One-Year Option Periods through July 31, 2031 Estimated Total Contract Value: $93,326.00 (Base + 4 Option Years) 1. CONTRACTING ORGANIZATION AND CONTRACTING ACTIVITY (FAR 6.303-2(b)(1)) This Justification and Approval (J&A) is prepared by the Department of Veterans Affairs (VA), Veterans Health Administration (VHA), RPO West, Network Contracting Office 17 (NCO 17), Lab Services Support (LSS), located at 5441 Babcock Rd., Suite 302, San Antonio, TX 78240, on behalf of the South Texas Veterans Health Care System (STVHCS), San Antonio, Texas. This document is identified as a 'Justification for Other Than Full and Open Competition' in accordance with FAR 6.303-2(b)(1). 2. NATURE AND DESCRIPTION OF ACTION BEING APPROVED (FAR 6.303-2(b)(2)) This J&A supports the award of a Firm-Fixed-Price (FFP), sole source contract to Richard-Allan Scientific, LLC. (d/b/a Epredia), the Original Equipment Manufacturer (OEM), for preventive maintenance and repair services for two (2) Epredia Excelsior Tissue Processors and one (1) Epredia HM525 Cryostat located in the Histology Laboratory of the Pathology & Laboratory Medicine Service at the South Texas Veterans Health Care System (STVHCS), Audie L. Murphy VA Hospital, San Antonio, Texas. The contract will be awarded using FAR Part 12 commercial service procedures and consists of a Base Year with four (4) one-year option periods (Base + 4 OYs), with an estimated total value of $93,326.00. The contract is a continuation of expiring Contract No. 36C25721P0979 (awarded 08/01/2021; expiring 08/01/2026; total value $93,990.00). 3. DESCRIPTION OF SUPPLIES OR SERVICES AND ESTIMATED VALUE (FAR 6.303-2(b)(3)) The Government requires OEM preventive maintenance and repair services for the following proprietary laboratory instrumentation currently installed and in active service at the STVHCS Histology Laboratory: (2) Richard-Allan Scientific, LLC. / Epredia Excelsior Tissue Processors S/N: ET55941709 and S/N: 3ET56691710 (1) Richard-Allan Scientific, LLC. / Epredia HM525 Cryostat S/N: CNX05692307EP The Contractor service program shall include, at a minimum: Onsite repair by Certified Richard-Allan Scientific, LLC. (Epredia) Field Service Engineers (FSEs) All replacement parts, labor, travel, and expenses for unscheduled repair visits One (1) annual scheduled Preventive Maintenance (PM) onsite visit All applicable instrument shipping charges 24/7 toll-free hotline with same-day response capability Emergency repair within twenty-four (24) hours from time of request Same-day repair when both instruments are simultaneously non-operational All repairs performed during normal working hours, 8:00 AM 5:00 PM, Monday Friday Services must comply with AABB and CAP accreditation requirements and VHA Directive 1106. Period of performance: Base Year August 1, 2026 July 31, 2027, plus OY1 through OY4 through July 31, 2031. Estimated total contract value (Base + 4 OYs): $93,326.00. 4. IDENTIFICATION OF THE STATUTORY AUTHORITY (FAR 6.303-2(b)(4)) The statutory authority permitting other than full and open competition for this procurement is: 41 U.S.C. § 3304(a)(1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements, as implemented by FAR 6.302-1(a)(1) and RFO FAR Part 6 (GSA Class Deviation, effective 2025 2026). Pursuant to FAR 6.302-1(b), this authority is used in preference to FAR 6.302-7 (Public Interest). None of the other circumstances enumerated at FAR 6.302-2 through 6.302-6 are applicable to this procurement. 5. DEMONSTRATION THAT PROPOSED CONTRACTOR'S UNIQUE QUALIFICATIONS OR THE NATURE OF THE ACQUISITION REQUIRES USE OF AUTHORITY CITED (FAR 6.303-2(b)(5)) 5.1 Proprietary Nature of Instrumentation: The Epredia Excelsior Tissue Processors and the Epredia HM525 Cryostat are proprietary, OEM-designed instruments manufactured and sold exclusively by Richard-Allan Scientific, LLC. (Epredia). The technical design, internal components, diagnostic algorithms, and calibration protocols for these instruments are proprietary intellectual property of Epredia, protected under applicable patent, trade secret, and intellectual property rights (FAR 6.302-1(b)(2)). Epredia does not publish, disclose, or license its technical service data, repair procedures, or calibration specifications to third parties. No independent third-party service organizations are authorized, trained, or certified by the OEM to perform maintenance or repairs on Epredia Excelsior Tissue Processors or the HM525 Cryostat. 5.2 OEM-Certified Field Service Engineers: Maintenance, repair, and calibration of the Epredia Excelsior Tissue Processors and HM525 Cryostat must be performed exclusively by Certified Richard-Allan Scientific, LLC. (Epredia) Field Service Engineers (FSEs). These FSEs possess exclusive access to OEM diagnostic tools, proprietary service software, technical service manuals, and OEM-approved replacement parts that are unavailable to any other service organization. Use of non-OEM-certified personnel would void manufacturer warranties, could cause instrument damage, and would constitute non-compliance with AABB and CAP accreditation requirements, directly jeopardizing the STVHCS Histology Laboratory's accreditation status and its ability to provide diagnostic pathology services to Veterans. 5.3 Accreditation and Regulatory Compliance: The STVHCS Histology Laboratory is accredited by both the American Association of Blood Banks (AABB) and the College of American Pathologists (CAP). Both accrediting bodies require that laboratory instrumentation be maintained and calibrated in accordance with the OEM's service standards, performed by OEM-certified personnel. VHA Directive 1106 additionally mandates compliance with these accreditation requirements for all VHA laboratory operations. Failure to use OEM-certified service personnel would place the STVHCS's AABB and CAP accreditation at risk, which would suspend the laboratory's ability to perform histological analyses and directly disrupt Veterans' access to pathology and cancer diagnostic services. 5.4 Continuity of Veteran Care: The Epredia Excelsior Tissue Processors and HM525 Cryostat are essential, mission-critical instruments used daily in the Histology Laboratory for the processing and sectioning of surgical and biopsy tissue specimens submitted for pathological diagnosis, including cancer diagnosis. Any disruption in the availability or reliability of these instruments directly delays diagnostic results for Veterans receiving care at the STVHCS. The Government's minimum need for continuous, uninterrupted OEM maintenance coverage cannot be met by any source other than Richard-Allan Scientific, LLC. (Epredia), consistent with FAR 6.302-1(b)(1)(i) unique services available from only one source or only one supplier with unique capabilities. 5.5 Prior Sole Source History: The prior contract for this identical requirement (Contract No. 36C25721P0979, awarded 08/01/2021 to Richard-Allan Scientific, LLC., total value $93,990.00, Base + 4 OYs) was awarded as a sole source under FAR 6.302-1. Award history in FPDS and SAM.gov confirms that multiple VA Network Contracting Offices procure maintenance for identical Epredia instrumentation on a sole source basis from Richard-Allan Scientific, LLC. (Epredia), further confirming the exclusive nature of this source. 6. EFFORTS TO ENSURE OFFERS ARE SOLICITED FROM AS MANY POTENTIAL SOURCES AS PRACTICABLE (FAR 6.303-2(b)(6)) The Contracting Officer undertook the following efforts to identify alternative sources and ensure the broadest practicable solicitation consistent with the nature of this requirement: Notice of Intent to Sole Source (NOI): On July 10, 2026, the Contracting Officer posted a Notice of Intent to Award a Sole Source Contract (NOI), Solicitation No. 36C25726Q0756, on the Government Point of Entry (GPE) at SAM.gov for ten (10) days (response deadline: July 20, 2026), in accordance with RFO FAR 5.207 and FAR 5.201. The NOI invited all responsible sources to submit capability statements demonstrating their ability to provide OEM-authorized maintenance services for the subject instrumentation. The response deadline is July 20, 2026. Only one response was received from the OEM Vendor: Company Name: Richard-Allan Scientific, LLC. (d/b/a Epredia) Address: 28 Progress Avenue, Kalamazoo, MI 49007 / 4-6 The Westlinks, Blossom Street, York, YO24 1AJ, UK UEI: N1LPLL6K6S58 CAGE Code: 044N0 SAM.gov Status: Active Socioeconomic Status: Foreign-Owned, For-Profit; Large Business POC / Contact: Cameron Booth, p: (269) 550-1399,e: cameron.booth@epredia.com SBA VetCert Database Search: A search of the SBA Veteran Small Business Certification (VetCert) database using NAICS code 811210 and keywords 'Epredia Tissue Processor Service,' 'Richard-Allan Scientific maintenance,' and related terms returned zero (0) certified SDVOSB or VOSB vendors. SBA Dynamic Small Business Search (DSBS): A search using NAICS code 811210 and relevant keywords returned zero (0) results. GSA eBuy / GSA Advantage: A search using PSC code J066 and OEM-specific keywords returned zero (0) applicable FSS contract holders. SAM.gov Award and Opportunity History Search: A search returned only two (2) prior VA NOIs for this same requirement (both sole source), confirming no competitive sources exist. UNICOR and AbilityOne: Searches of both mandatory sources returned zero (0) applicable results. No exception under FAR 5.202 is applicable. The NOI was published as required. All market research is documented in the Market Research Report (MRR) prepared for this acquisition and retained in the contract file. 7. DETERMINATION THAT THE ANTICIPATED COST TO THE GOVERNMENT WILL BE FAIR AND REASONABLE (FAR 6.303-2(b)(7)) The Contracting Officer has determined that the anticipated price of $172,796.79 (Base + 4 Option Years) is fair and reasonable based on the following analysis: (a) Historical Price Comparison: The prior contract for this identical requirement (Contract No. 36C25721P0979, awarded 08/01/2021) had a total value of $93,990.00 for Base + 4 Option Years. (b) OEM Market Pricing: OEM service contracts for laboratory instrumentation of this type are customarily priced on a per-instrument, per-year basis in the commercial marketplace. The quoted pricing is consistent with the commercial market rates for OEM service programs for similar anatomical pathology instrumentation. (c) Price Analysis Method: Price reasonableness is established by comparison to the prior contract award price, adjusted for inflation using applicable indices, and by reference to commercial OEM service contract pricing for comparable laboratory instrumentation. A Price Reasonableness Memorandum for Record (MFR) will be completed prior to contract award and retained in the contract file in accordance with FAR 13.106-3(a). 8. DESCRIPTION OF MARKET RESEARCH AND RESULTS (FAR 6.303-2(b)(8)) Market research was conducted in accordance with RFO FAR Part 10 (GSA Class Deviation RFO-2025-10), VAAR 810.001-70, and VAAM M810.002-70, during June July 2026. Research techniques included: (1) SBA VetCert database search; (2) SBA DSBS database search; (3) posting of a ten-day NOI on SAM.gov; (4) GSA eBuy/Advantage search; (5) SAM.gov award and opportunity history search; (6) UNICOR search; (7) AbilityOne search; and (8) commercial internet research including review of the OEM's corporate website and laboratory equipment service industry resources. Results: All research sources confirmed that Richard-Allan Scientific, LLC. (Epredia) is the sole OEM and only known responsible source capable of providing the required OEM-certified maintenance services for the subject instrumentation. No certified SDVOSBs, VOSBs, other small businesses, or any other commercial service providers capable of fulfilling this requirement were identified. The VA Rule of Two cannot be met. Full market research results are documented in the Market Research Report (MRR) prepared for this acquisition, which is incorporated herein by reference and retained in the contract file. 9. OTHER FACTS SUPPORTING USE OF OTHER THAN FULL AND OPEN COMPETITION (FAR 6.303-2(b)(9)) The following additional facts support this sole source determination: Technical Data / Specifications Not Available (FAR 6.303-2(b)(9)(i)): Technical data packages, specifications, engineering descriptions, and service procedures for the Epredia Excelsior Tissue Processors and HM525 Cryostat are proprietary to Richard-Allan Scientific, LLC. (Epredia) and have not been released or made available to the Government or to third parties. No technical data package suitable for enabling full and open competition exists or is available. Follow-On Acquisition (FAR 6.302-1(a)(2)(iii)): This is a follow-on contract for the continued provision of highly specialized OEM maintenance services for instrumentation that was originally procured under brand-name specifications. Award to any source other than the OEM would result in unacceptable delays in fulfilling the STVHCS Histology Laboratory's accreditation and operational requirements and would risk substantial duplication of costs associated with instrument damage, accreditation sanctions, and procurement of replacement equipment. Proprietary Replacement Parts: Replacement parts for the Epredia Excelsior Tissue Processors and HM525 Cryostat are exclusively available from Richard-Allan Scientific, LLC. (Epredia). No aftermarket or compatible parts sources have been identified in the commercial marketplace. Patient Safety and Mission Impact: Any failure or extended downtime of this instrumentation which would result from use of non-OEM personnel or from a lapse in service contract coverage directly impacts the STVHCS's ability to process pathology specimens and deliver timely cancer and surgical diagnostic results to Veterans. This constitutes an unacceptable risk to patient safety and mission continuity. 10. LISTING OF SOURCES THAT EXPRESSED, IN WRITING, AN INTEREST IN THE ACQUISITION (FAR 6.303-2(b)(10)) As of the date of preparation of this J&A, no sources other than Richard-Allan Scientific, LLC. (Epredia) have expressed, in writing, an interest in this acquisition. The Notice of Intent to Sole Source (NOI), Solicitation No. 36C25726Q0756, was posted on SAM.gov on July 10, 2026, with a ten (10)-day response window (deadline: July 20, 2026). No capability statements, responses, or objections have been received. This section will be updated prior to award if any responses are received during the NOI response period. 11. STATEMENT OF ACTIONS THE AGENCY MAY TAKE TO REMOVE OR OVERCOME BARRIERS TO COMPETITION (FAR 6.303-2(b)(11)) The Contracting Officer recognizes the importance of promoting full and open competition to the maximum extent practicable in accordance with CICA (41 U.S.C. § 3301) and RFO FAR Part 6. The following actions are considered for future acquisitions: (a) Technical Data Rights: The Contracting Officer will consult with the requiring activity and STVHCS Pathology & Laboratory Medicine Service to explore whether technical data rights or maintenance manuals for the Epredia instrumentation could be obtained from the OEM as part of a future equipment procurement or service negotiation, which might enable greater competition in future service contract cycles. (b) Equipment Lifecycle Planning: At the time of next equipment replacement or upgrade, the requiring activity will be advised to ensure that maintenance interoperability, third-party serviceability, and competitive service contract availability are considered as evaluation factors in the equipment procurement, consistent with FAR 7.105(b)(1)(ii). (c) Ongoing Market Monitoring: The Contracting Officer will continue to monitor the market for the potential emergence of OEM-authorized third-party service providers or alternative instrumentation sources that could enable future competitive acquisitions. 12. REQUIREMENTS PERSONNEL CERTIFICATION (FAR 6.303-2(c)) I certify that the requirement described in this Justification and Approval is an actual, bona fide need of the Department of Veterans Affairs, South Texas Veterans Health Care System (STVHCS), Pathology & Laboratory Medicine Service, Histology Laboratory. The supporting data within my cognizance that forms the basis of this justification, including the description of the proprietary nature of the instrumentation, the OEM service requirements, and the accreditation compliance requirements, is accurate and complete to the best of my knowledge and belief. Signature: ____________________________________________ Name: Lara Cruz, Susana Title / Position: Medical Technologist Service / Department: Pathology & Laboratory Medicine Service, STVHCS 13. CONTRACTING OFFICER CERTIFICATION AND APPROVAL (FAR 6.303-2(b)(12) | FAR 6.304(a)(1)) I certify that this Justification for Other Than Full and Open Competition is accurate and complete to the best of my knowledge and belief. Approval Authority Note: The estimated total contract value is $172,796.79 (Base + 4 Option Years), which does not exceed the $900,000 threshold at FAR 6.304(a)(1) (as updated by FAC 2025-06, effective October 1, 2025). In accordance with FAR 6.304(a)(1), the Contracting Officer's certification below serves as the sole required approval for this J&A. No Competition Advocate or higher-level approval is required. Signature: ____________________________________________ Ognian D. Ivanov Contracting Officer Department of Veterans Affairs, Veterans Health Administration RPO West | NCO 17 | Lab Services Support (LSS) 5441 Babcock Rd., Suite 302, San Antonio, TX 78240 Date: _______________________ 14. PUBLIC AVAILABILITY (FAR 6.305) In accordance with FAR 6.305 and RFO FAR Part 6, this J&A shall be made available for public inspection at the GPE (SAM.gov) within fourteen (14) days after contract award. Prior to posting, the Contracting Officer shall review this document to ensure no proprietary, sensitive, or operationally sensitive information is disclosed. This J&A will be posted on SAM.gov concurrent with or following contract award in accordance with FAR 6.305(b) and (c).