LSJ 2026 UA redacted 1026_Redacted.pdf

Limited Sources Justification

VHAPG Part 808.405-6 Limiting Sources Page 1 of 8 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C256-26-AP-4227

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C256-26-AP-4227

(1) Contracting Activity:

Department of Veterans Affairs, VISN 16 South Central VA Health Care Network (SCVAHCN) Network Contracting Activity (NCO) 16

(2) Description of Action: This acquisition is conducted under the authority of the Multiple- Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501 South Central VA Health Care Network (SCVAHCN- VISN 16) intends to award a short-term, fixed price Blanket Purchase Agreement (BPA) under the statutory authority as implemented by Federal Acquisition Regulation (FAR) Subpart 8.405-6 (b)(3) to the incumbent contractor, Beckman Coulter, Inc., for the continued provision of automated urinalysis instrumentation, digital imaging microscopy, reagents, calibrators, controls, training, service and interfacing for V16 medical center and outpatient clinic laboratories. VISN 16 laboratories are currently utilizing these items under a short-term sole source BPA which expires September 30, 2026. Participating laboratories, equipment in use, the required test menu, and estimated annual volumes are provided in Attachment A. BPA with a six-month base period, with a 3 month option is being requested. The BPA will be effective October 1, 2026, through March 31, 2027.

Order against: FSS Contract Number: V797D-70260

Name of Proposed Contractor: Beckman Coulter, Inc.

Street Address: 250 S. Kraemer Blvd.

City, State, Zip: Brea, CA 92821 Phone: 714-872-6271

(3) Description of Supplies or Services:

The estimated value of the proposed action is

Base Period- (6 months)

Option Period- (3 months)

Total Estimate

VHAPG Part 808.405-6 Limiting Sources Page 2 of 8 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C256-26-AP-4227

Award of a new short-term BPA will allow for continued use of existing instrumentation. It will ensure the contractor continues to provide instrumentation, reagents and consumables as defined for CPRR (cost per reportable result) in the Federal Supply Schedule FSC Group 66 III CPT/CPRR program for the performance of patient testing in participating V16 laboratories. It will also ensure the contractor continues to meet all licensing and accreditation requirements, permits, certifications required by the FDA and the Government. All provisions within the original BPA and Statement of Work (SOW) have been incorporated into the short-term BPA with the incumbent, including use of equipment (all testing instrumentation, UPSs), preventative maintenance, emergency repair, reagents, controls, calibration materials, etc. Under the BPA Beckman Coulter will continue to provide instrumentation for 8 medical-center and 20 outpatient clinic laboratories. Instrumentation is operating at an acceptable level. The BPA will continue to provide 17 fully automated urinalysis IQ Workcells (integrated automated macroscopic chemical analysis instrumentation with automated digital urine microscopy instrumentation), 20 stand-alone AX-4030 macroscopic urine chemical analysis analyzers, reagents, calibrators, controls, training, preventative maintenance, equipment repair, and interfacing of test results through data innovations middleware to the VA VistA lab package for clinician viewing in the electronic medical record.

Instrumentation is currently deployed and validated for use for patient testing at each participating laboratory. Automated digital urine microscopy results from this instrumentation have been correlated to manual microscopy and verified for clinical use in each participating lab.

Appropriate staff have been trained, competency assessed, and procedures written for clinical use of this instrumentation for patient care per VHA and regulatory agency requirements. Testing instrumentation is bi-directionally interfaced through data innovations to the VA VistA lab package. It is necessary to award a short-term BPA to the incumbent for continued use of existing instrumentation as it is the best method of satisfying the Government’s requirement while preventing delays in care for our Veterans and increased costs to the Government.

Key stakeholders include the Lab Directors and Clinical Laboratory Scientists performing testing at each VISN 16 medical center and outpatient clinic laboratory as well as clinicians utilizing test results and Veterans benefitting from access to critical testing across the Network.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

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FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized;

Beckman has successfully provided automated urinalysis testing instrumentation, troubleshooting, repair, proprietary reagents and consumables under a VISN wide CPRR BPA. A BPA was competitively awarded from solicitation 36C25619Q0225 to Beckman Coulter, Inc.

Short-term sole source BPA expiring September 30, 2026, was awarded to the incumbent, Beckman Coulter, to allow for continuation of testing while the acquisition packet for the long-term requirement is being developed. Instrumentation includes proprietary testing instrumentation for macroscopic analysis and automated digital microscopy of urine at VISN 16 laboratories. Testing instrumentation is interfaced to VistA through Data Innovations Middleware eliminating the need to manually program patient testing and manually input patient test results into the VistA laboratory package. The contractor shall continue to provide high quality proprietary reagents, calibrators, consumables and related items for the performance of the testing. The program office has assembled a work group of clinical laboratory scientists to serve as subject matter experts (SMEs) for the development of an acquisition packet for a long-term BPA solicitation for automated urinalysis instrumentation and testing. The draft statement of work was shared with industry. The award of a short-term BPA will ensure continuity of contract coverage while allowing sufficient time for a new BPA to be solicited and awarded, as well as for the installation of new instrumentation. This period will also provide the necessary time to complete all required method verification and correlation studies associated with the implementation of new instrumentation. In addition, this period will allow adequate time for the assessment of the age and operational status of existing urinalysis instrumentation and the review of current contract status for the new laboratories that will soon align under legacy VISN 16 within Health Service Area (HSA 41) as part of the VHA RISE reorganization plan. If deemed necessary, allowing for the inclusion of these additional laboratories will further support longstanding standardization efforts and strategic sourcing initiatives for laboratory testing across the network. This period also provides sufficient time to incorporate these laboratories into the applicable contracting documents, as such additions and revisions may influence contracting timelines and required approvals based on projected testing volumes, anticipated workload changes, and specific instrumentation requirements. The need to continue to provide these laboratory tests to veterans is critical. Without this award, the laboratories will not have equipment or reagents available for the performance of these critical tests required for patient care. Once a new, long-term BPA is awarded and before existing equipment can be replaced, extensive installations, training and validation/correlation studies are required at each laboratory.

If a new contractor is selected, new test files will need to be set up in the lab package and test files for interfacing must be set up in the middleware for interfacing of test results into the lab package at each facility. Basic operator training to be provided to all staff by the Contractor.

Advanced/key operators at all participating labs will go off-site for training on digital microscopy instrumentation; upon their return, all remaining staff will be trained. New standard

VHAPG Part 808.405-6 Limiting Sources Page 5 of 8 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C256-26-AP-4227

Search of SIN 605-4a in the GSA elibrary identified 3 vendors in the SIN. They are Beckman (LB), Siemens (LB), and Sysmex (LB). Review of the Beckman Coulter contract indicated they have both the automated macroscopic urine chemical analysis instrumentation and automated digital urine microscopy instrumentation. Review of the Siemens FSS contract indicated they no longer have laboratory instrumentation under SIN 605-4a. Review of the Sysmex contract

VERTSCERTS

NAICS – 334516 2 vendors The capability narratives submitted by both certified firms indicate that neither clearly demonstrates the ability to meet the specific technical requirements of this acquisition. Their stated capabilities do not sufficiently align with the specialized analytical laboratory instrument manufacturing or related performance criteria required for this procurement.

SBA Dynamic Small Business

SBA Dynamic Small Business Search - NAICS 334516 - 2 active SBA certifications SBA Dynamic Small Business Search - Automated Urinalysis Instrumentation and Testing

CPRR” 0 VENDORS

The capability narratives submitted by both certified firms indicate that neither clearly demonstrates the ability to meet the specific technical requirements of this acquisition. Their stated capabilities do not sufficiently align with the specialized analytical laboratory instrument manufacturing or related performance criteria required for this procurement.

ADDSUP

Market research utilizing the Adds Up resource was conducted utilizing NAICS 334516, which covers analytical laboratory instruments commonly associated with diagnostic and testing equipment. The search returned 3680 active contracts therefore verifying that there are available sources that can potentially fulfill this requirement.

ADDSUP “Automated urinalysis macroscopic and digital urine microscopy instrumentation, reagents, service and interfacing under a CPRR agreement yielding 89 active contracts. The search provided proof of the availability of sources that can potentially fulfill this requirement.

GSA eLibrary

The following have been identified as having an FSC 66 III FSS Schedule Contract under SIN 605-4a that includes automated urinalysis macroscopic and digital urine microscopy instrumentation, reagents, service and interfacing under a CPRR agreement -

• Beckman Coulter Inc. (LB) FSS# V797D-70260 Mark Watanabe mswantanabe@beckman.com 714-872-6271

• Siemens Healthcare Diagnostics (LB)- FSS# V797D-30175 Cathy Knutsen cathy.m.knutsen@siemens-healthineers.com 714-665-3235

• Sysmex America, Inc. (LB) V797D-40235 dunnS@sysmex.com 224-543-9376

VHAPG Part 808.405-6 Limiting Sources Page 6 of 8 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C256-26-AP-4227 provided that they offer the Siemens Clinitek urinalysis instrumentation alongside the Sysmex automated digital microscopy instrumentation. Per the terms and conditions posted on the GSA elibrary both Beckman and Sysmex has the ability to respond to a solicitation for automated macroscopic urine chemical analysis instrumentation, automated digital urine microscopy instrumentation, reagents, training, service, and connectivity with VA VistA utilizing CPRR pricing. Both Beckman and Sysmex indicated interest in an Industry Day notice. As part of market research engagement with industry, both are reviewing a draft copy of the statement of work. It is anticipated that each of the offers will respond to the sources sought notice, participate in vendor site visits and submit a technical quotation in response to the competitively posted RFQ in the future. Due to the various instruments listed on each of the offerors’ respective FSS contracts, functionality of equipment, different technical requirements within the SOW and testing requirements of each participating laboratory, it is unknown at this time if the combinations of instrumentation and reagents quoted by each offeror will meet the Governments requirements. This cannot be determined until an RFQ response is submitted and evaluated by the Source Selection Evaluation Team (SSET) against the technical requirements of the RFQ and technical evaluation factors and subfactors.

Beckman Coulter instrumentation is currently deployed and fully validated for clinical testing across all participating VISN 16 laboratories. Laboratory personnel are already trained and competent on these systems, and all required procedures have been developed, approved by the respective laboratory medical directors, and implemented in active operations. The instrumentation is also fully bi-directionally interfaced with VA VistA, ensuring seamless transmission and integration of patient test results. Given these established systems, processes, and interfaces, Beckman Coulter is the only contractor capable of meeting the operational requirements for the eight medical centers and twenty outpatient clinic laboratories by the required date of October 1, 2026, without disruption to patient testing services. Transitioning to any other contractor would require significant retraining, new validations, interface establishment, and procedural updates, resulting in unacceptable delays and interruptions to essential clinical testing.

National Strategic Source Listing (NSSL)

National Strategic Source Listing (NSSL) using the following keywords and filters: “NAICS 334516,” “6630,” “66 III,” “automated urinalysis macroscopic and digital urine microscopy instrumentation, reagents, service and interfacing under a CPRR agreement” resulted in their capabilities potentially not being able to fulfill the requirement, however, the search provided proof of the availability of services.

(7) Any Other Facts Supporting the Justification:

Due to competing priorities and ongoing operational demands, the Program Office, Contracting, and VISN subject matter experts are progressing on the development of the long-term solicitation packet as staff availability and workload permit. Several VISN-wide laboratory procurements and instrumentation upgrades are already in the queue and must be completed prior to initiation of this requirement. VISN 16 continues to coordinate closely with NCO 16 on

VHAPG Part 808.405-6 Limiting Sources Page 7 of 8 Revision: 02 Effective Date: 03/02/2026 Acquisition ID#: 36C256-26-AP-4227 standardized procurements and systemwide installation of instrumentation and associated equipment across the network.

Additionally, as VHA begins implementation of the VHA RISE reorganization, VISN 16 is actively working to engage and integrate the laboratories that will realign under Health Service Area (HSA) 41. Ensuring uninterrupted patient testing remains the highest priority; therefore, approval of this sole-source action is essential to prevent any adverse impact on patient care.

Current BPA pricing has yielded

. Under the existing arrangement, laboratories obligate funds annually through a purchase order supporting CPRR invoicing in arrears. Without a short-term, VISN-wide BPA, each participating laboratory would be required to prepare and submit individual sole-source procurement actions, resulting in inefficiencies, increased administrative burden, loss of economies of scale, and likely higher prices.

Alternative approaches present substantial risks. Manual performance of testing would require additional staffing resources and manual entry of results, leading to extended turnaround times and reduced testing capacity. The award of a short-term BPA to the incumbent is therefore essential to maintain access to timely and accurate macroscopic urine chemical analysis and automated digital urine microscopy, along with the necessary service and support.

This requirement has a high potential to negatively affect Veteran care if not awarded.

Maintaining ready access to routine and stat urinalysis testing is mission-critical for all medical centers and urgent care centers across the network. A bridge BPA is therefore essential to mitigate the risk of service interruption and to ensure uninterrupted diagnostic support for patient care.

(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made: Competition is planned among FSS contract holders for the new long-term VISN wide BPA. NCO 16 has engaged with industry and a draft copy of the statement of work has been shared for feedback. Award of this short-term bridge BPA will allow for continued use of automated macroscopic urine chemical analysis instrumentation and automated digital urine microscopy instrumentation for 8 medical center and 7 outpatient clinic laboratories and automated macroscopic urine chemical analysis instrumentation for 13 outpatient clinic labs so that patient care is not negatively affected.

(9) 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. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR

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