LSJ_Redacted.pdf

Attachment 2: Request for Limited Sources Justification Format >SAT

VHAPG Part 808.405-6 Limiting Sources Page 1 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: ____________

LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C250-26-AP-0360

(1) Contracting Activity: The Department of Veterans Affairs, Veterans Integrated Service Network (VISN) 10, Louis Stokes Cleveland Veterans Affairs Medical Center (CLE VAMC) Network Contracting Office (NCO) 10.

Transaction: 541-26-1-775-0003

(2) Description of Action: Network Contract Office (NCO) 10 intends to award a new, firm fixed price, brand name only, FSS Delivery Order base plus four (4), one (1) year options, for a total of five years, contract to Beckman Coulter. The request is for Urinalysis automated solution to streamline urinalysis workflow and testing procedure for the Pathology and Laboratory Medicine Service (PLMS).

Order against: FSS Contract Number: V797D-70260 ( exp Oct 5, 2027) Name of Proposed Contractor:

Beckman Coulter

Street Address:

250 South Kraemer Boulevard

City, State, Zip:

Brea, California 92821- 8000

Phone: (714) 872-6271 Email: plantner@beckman.com

(3) Description of Supplies or Services: The VA Northeast Ohio Healthcare System (VANEOHS) Pathology and Laboratory Medicine Service, requires a Urinalysis automated solution to streamline urinalysis workflow and testing procedures. This solution shall include equipment, installation services, reagents, consumables, maintenance/support services, and training.

The estimated value of the proposed action is $

The Contractor shall provide, under a “reagent rental” or “Cost-per-Reportable Test” basis, all equipment, installation, reagents, calibrators, controls (Contractor shall provide controls manufactured for QC use with his/her instrumentation. Contractor will be required to provide 3rd party controls (in case manufacturer controls do not meet Lab’s requirements), consumable supplies, linearity testing materials, interface to VA Vista system including hardware, software, and licensing, and costs for the DI water system (if required), training of end users, and system

VHAPG Part 808.405-6 Limiting Sources Page 2 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: ____________ maintenance (including parts, labor, travel) and all shipping costs, during the term of this agreement to support Urinalysis Analyzers that are provided under Contract V797D-70260.

The instrumentation shall perform all analysis for the required tests with precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

The DxU Iris Workcell is a fully integrated urinalysis platform combining automated urine chemistry with digital flow morphology microscopy in a single, walk-away system. Key features include:

Auto-Particle Recognition (APR) for automated urine sediment classification.

Edit-Free Release decision rules reducing manual microscopy review to < 3–4% of samples.

Throughput up to ~210 samples/hr (chemistry) and 70–101 samples/hr (microscopy) with reflex testing between modules.

Minimal sample volume requirements (as low as ~3 mL, unspun).

Integrated interference detection (ascorbic acid pad) for urinalysis strip chemistry.

This system directly supports VA laboratory operations by improving workflow efficiency, increasing consistency of results, and reducing turnaround time for patient testing.

(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)(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; The DxU Iris Workcell is the only commercially available platform that integrates urine strip chemistry and fully automated digital microscopy into a unified workcell with true walk-away capability.

Competing systems either:

Perform urine chemistry only (no integrated particle imaging), or Require manual or semi-automated microscopy review, increasing hands-on labor and error risk.

Standardization of results, reduction in manual review, and automated decision rules are unique to Beckman Coulter’s platform and critical to meeting VA clinical laboratory standards.

Market research (via GSA Advantage search, vendor outreach, and industry publications) confirmed no other product provides this combination of features.

VHAPG Part 808.405-6 Limiting Sources Page 3 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: ____________

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination: The Beckman Coulter DxU Iris Workcell Automated Urinalysis System represents the best value to the Government because it combines technical superiority, workflow efficiency, and cost-effectiveness under an existing MAS contract with pre-negotiated fair and reasonable pricing.

Technical:

Integrates urine chemistry and digital microscopy into a single platform, eliminating the need for separate analyzers and manual sediment review.

Features Auto-Particle Recognition (APR) and Edit-Free Release, reducing manual review to <3–4% of samples, which no competing MAS-listed system can match.

Provides standardized, high-quality results necessary to support VA clinical laboratory operations and patient care.

Workflow and Cost Efficiency:

High throughput (up to ~210 samples/hr chemistry and 70–101 samples/hr microscopy) enables faster turnaround and increased patient testing capacity without additional labor.

Reduces hands-on time by up to ~78% compared to conventional workflows, freeing laboratory personnel for higher-value tasks and minimizing staffing costs.

Decreases the risk of diagnostic delays and repeat testing, avoiding costs associated with inefficiency or inaccurate results.

MAS Pricing and Compliance:

Beckman Coulter’s MAS contract pricing has already been evaluated by GSA for fairness and reasonableness, meeting FAR 8.404(d) requirements.

Ordering under MAS streamlines procurement, reducing administrative burden and ensuring timely delivery.

Given these factors, this order achieves best value by combining clinical performance, labor efficiency, and pre-competed pricing. Alternative products would require separate instruments or additional manual labor, resulting in higher life-cycle costs and reduced standardization.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

Market research included:

Review of other urinalysis analyzers available under MAS contracts.

Contact with alternative vendors to assess product capabilities.

VHAPG Part 808.405-6 Limiting Sources Page 4 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: ____________

Technical review by VA laboratory specialists confirming lack of an equivalent integrated workcell solution.

No other MAS contractor was identified that could provide a functionally equivalent system.

GSA eLibrary, ECAT, SAM.gov, Interagency Contract Directories, NAC, FPDS, SCMC, MSVP, BIC and FDA:

o Keywords Used: "urinalysis" o Results: Beckman Coulter is the only one that meets the requirements.

DSBS:

o NAICS Code Searched: 334516 (Analytical Laboratory Instrument

Manufacturing) o Keywords Used: " urinalysis" o Results: none that meet requirements

(7) Any Other Facts Supporting Justification:

Life-Cycle Cost Advantages:

Lower Consumables and Labor Cost per Test:

o Reduced manual review, fewer slide preps, and lower reagent usage contribute to a lower cost per reportable result over the equipment’s service life.

Long-Term Upgrade Path:

o The DxU Iris platform is modular and software-upgradable, extending its useful life and protecting VA’s capital investment.

(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: On-going research of the industry market place will be conducted to determine if there are new entrants into this product arena.

(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 Subpart 8.4. (This signature is the requestor’s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)

Mayra Rosado Laboratory Manager/Assistant Chief P&LMS Louis Stokes Cleveland VAMC

VISN 10

ROBERT

MCPEAK

Digitally signed by ROBERT

MCPEAK

Date: 2025.09.02 13:55:26 -04'00'

VHAPG Part 808.405-6 Limiting Sources Page 5 of 5 Revision: 01 Effective Date: 09/01/2024 Acquisition ID#: ____________

(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP: This part if filled out by Contracting Staff as part of the Justification

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

Rachelle J. Hamer Contracting Officer Network Contracting Office (NCO) 10

b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K):

I certify the justification meets requirements for other than full and open competition.

Adam P. Weber Branch Chief – Supply Team 1

Network Contracting Office (NCO) 10

RACHELLE

HAMER

Digitally signed by

RACHELLE HAMER

Date: 2025.09.02 14:17:41 -04'00'

ADAM WEBER

Digitally signed by ADAM

WEBER

Date: 2025.09.02 14:20:23 -04'00'