P03 SSJ Beckman Coulter-WB HCA.pdf

AP# 36C244-27-AP-0095 | Wilkes Barre

SOLE SOURCE JUSTIFICATION

GSAM/R 538.7104-3(b)

This justification aligns with the deviation outlined in the Revolutionary FAR Overhaul (RFO) for FAR 8.4 - Ordering under the Federal Supply Schedule and GSAM/R 538.71, as required by Executive Order (E.O.) 14275, Restoring Common Sense to Federal Procurement, signed April 15, 2025. Deviation effective date: November 3, 2025.

Acquisition Plan Action ID: 36C244-27-AP-0095

1. Contracting Activity: Department of Veterans Affairs, Network Contracting Office 4, located at 1111 East End Boulevard, Wilkes-Barre, PA 18711, in support of VISN 4 VA Health Care System at Wilkes-Barre VA Medical Center(WBVAMC), 1111 East End Boulevard, Wilkes-Barre, PA 18711. Reference 2237/PR# 693-27-1-050-0001.

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); GSAM/R 538.71 ordering procedures as directed by FAR 8.4.

Order against: FSS Contract Number: V797D-70260 Name of Proposed Contractor: Beckman Coulter, Inc.

Street Address: 250 S. Kraemer Boulevard City, State, Zip: Brea, California 92821 Phone:

SAM UEI:

POC:

Email:

480-339-9213

PU6HHX2R11C7

Kort Wickenheiser kmwickenheiser@beckman.com

3. Description of Supplies or Services:

The estimated value of the proposed action is $6,087,137.00. WBVAMC requires a seven-year procurement for the instrumentation, reagents, supplies, and services to perform Clinical Laboratory Chemistry, Immunochemistry, Chemiluminescent and Hematology Testing on an automation line with auto-verification. This procurement is to accommodate the medical center’s compatibility of testing requirements with all facility equipment.

This procurement includes a lease of a replacement automation line (Beckman DxA 5000), replacing the facility's existing Power Express automation line (VA equipment inventory Entry #45224, purchased 2017, total asset value $1,561,371.22, 10-year documented life expectancy, official replacement date May 18, 2027).

The following products will be ordered:

TEST ESTIMATED ANNUAL VOLUME

Glucose 61471

BUN 61603

Creatinine 111285

NA 61380

K 61950

Cl 61585

CO2 61363

Calcium 61517

Phosphorous 12810

Total Protein 54510

Albumin 56191

Alkaline Phosphatase 24170

AST 54200

LD 795

TBil 54148

DBIL 4979

Cholesterol 33427

TG 33543

HDLD 33423

ALT 54182

Amylase 835

Lipase 12636

Magnesium 19080

Uric acid 2990

ETOH 924

Carbamazepine 42

Digoxin 154

Phenobarbital 10

Dilantin 43

Theophylline 15

Valproic acid 360

Vancomycin 438

Amphetamine 5629

Barbiturate 5609

Benzodiazepine 5623

Cannabinoids 5597

Cocaine 5618

Methadone 5620

Opiate 5620

Phencyclidine 5596

Propoxyphene 5320

Ammonia 1934

GGT 690

CK 2601

Lactic Acid 2155

Micrototal Protein 5602

LDLD 33423

Oxycodone 5610

Lithium 196

Salicylate 48

Microalbumin 11245

Acetaminophen 58

CKMB 964

Troponin I 4393

PSA 9317

Free PSA 2632

BhCG 153

TSH 27074

FT4 14891

Procalcitonin 890

Vitamin D 23720

Fentanyl 8254

Parathyroid Hormone 1364

Buprenorphine 2528

Ferritin 3380

Transferrin 4196

BNP (B-type natriuretic peptide) 2902

Body Fluids 520

Complete Blood Count with Automated Differential including a measured (MDW)

53869

Reticulocyte Count 591

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.

GSAM/R 538.7104-3(b)(1)(ii): 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 Coulter is the sole proprietor of the Remisol advanced software for auto-verification. Currently, WBVAMC Lab has total lab automation that connects to multiple Beckman Instruments. Additionally, the WBVAMC upgraded its Beckman DxC700AU chemistry and DxH900-2S hematology instrumentation within the last year. One of these instruments is the DxH900-2S Hematology Workcell technology which Beckman Coulter is the exclusive manufacturer and sole distributor of Monocyte Distribution Width (MDW) in the United States. MDW is the only FDA approved, regulatory-cleared, hematological biomarker that helps to establish risk of severe infection and sepsis in adult patients in the Emergency department. Beckman Coulter has additionally confirmed via proprietary letters (uploaded to the briefcase) that it is the sole source for reagents, controls, and instrument service/support for both the DxC700AU and DxH900-2S platforms.

The DxA 5000 Automation Line includes a Tube Inspection Module that determines spun versus unspun status and automatically prioritizes STAT samples throughout the analytical process, eliminating manual intervention or pre-sorting of chemistry, immunoassay, and hematology tubes. The DxI9000 immunoassay analyzer uses four onboard HD cameras and image-analysis algorithms (PrecisionVision) to continuously monitor testing steps, a capability Beckman states is not available on other immunoassay analyzers. Scopio X100 is an FDA-cleared digital cell morphology platform providing full-field peripheral blood smear imaging with AI-assisted analysis. The DxH900-2S provides near-native-state cellular analysis, including direct measurement of MCV and MRV.

A competing vendor would need to replicate several Beckman-specific technical functions to integrate into WBVAMC's current environment: direct sample receipt into the automation line's auto-verification interface, proprietary communications protocols with Remisol Advance middleware, and multi-instrument workflow orchestration built around Beckman analyzers. The alternate vendor's capability statement did not demonstrate any of these functions. Replicating them would require a separate middleware/auto-verification platform, new rule development and validation, interface build and testing, and significant additional staff time.

5. Describe Why You Believe the Order Represents the Best Value consistent with GSAM/R 538.7102-2(4) to aid the contracting officer in making this best value determination: WBVAMC would experience substantial duplication of cost that could not be expected to be recovered through competition and unacceptable delays if this was open to full and open competition. The WBVAMC Laboratory does not currently have the manpower to rebuild all the auto verification algorithms for each of the tests. The current auto verification installation took several years to complete due to limited manpower. The estimated total hours for the labs information manager in these efforts was over 1000 hours.

Due to the nature of the work required, there is only one position in the organizational chart that can complete these tasks. This sole source represents the best value because the vendor is the singular supplier of Remisol software compatible tests and they are supplied under their existing FSS contract.

Remisol Advance is also the middleware platform currently supporting WBVAMC's Stago coagulation and microbiology testing, as well as the chemistry quality control (QC) program, beyond the scope of this specific procurement. Replacing Remisol would therefore affect verification workflow and QC management across multiple laboratory sections, not solely the tests within this action's scope.

Should the requirement be awarded to an alternate source, WBVAMC would need to procure a separate auto-verification/auto-validation platform. A 2026 estimate for a comparable wrapper-rules build and implementation assistance from Data Innovations was approximately $146,434.18. Pricing may differ depending on whether an alternate source's platform supports auto-validation directly or requires implementation via Instrument Manager. A new installation and validation process is estimated to take approximately 3 to 6 months per department (chemistry and hematology), meaning WBVAMC would operate without auto-validation capability for up to approximately one year during transition.

The facility's existing automation line has reached the end of its documented 10-year life expectancy (replacement date May 18, 2027, per VA equipment inventory records) and requires replacement independent of this procurement's other requirements. The replacement automation line (DxA 5000) is being incorporated into this procurement as a lease.

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 was conducted in accordance with FAR Part 10.

a. Small Business Search (SBS) – search using NAICS 334516 and keyword “Beckman, Hematology, Chemistry Testing”. The search generated zero capable vendors.

b. GSA Market Research Tool: A search was conducted using the keyword “Beckman.”

This search generated results for Beckman Coulter LLC with Contract Number V797D- 70260.

c. Intent to Sole Source: 36C24426Q0756 was published to https://sam.gov from 07/02/2026 through 07/08/2026. One response received from Abbott (LB). The submission was reviewed against WBVAMC's requirement for middleware compatible with existing auto-verification, QC management, and instrument connectivity infrastructure (Remisol Advance), which is proprietary to Beckman Coulter. The submission did not identify a compatible alternative to this middleware function.

d. Virtual Industry Day: Special Notice 36C24426Q0882 was published to sam.gov announcing a Virtual Industry Day held on August 20, 2026, from 9:00 a.m. to 1:00 p.m.

EST, inviting industry to present capabilities responsive to the facility's requirements.

Capability statements were received from four Large Businesses, and three participated.

The findings indicate that a solution meeting the facility's hematology connection and integrated auto-verification requirements is not currently available in the marketplace within a timeframe consistent with the facility's operational needs; respondents' comparable hematology connectivity capability was estimated at 6 months to 2 years from availability. One respondent's offering did not include chemistry automation.

Transitioning to an alternate platform would require an estimated $146,434.18 for the necessary data interface and up to approximately 18 months before auto-verification capability could be established. Based on the capabilities presented, only the incumbent platform currently meets the full scope of the facility's integrated chemistry, hematology, and auto-verification requirements without a substantial gap in capability.

e. Contacting knowledgeable individuals in Government and industry regarding market capabilities to meet requirements-An email was sent to Beckman Coulter, and they provided proprietary letters for several products as well as information of the considerable amount of time and efforts that the station put into the recent upgrades.

7. Any Other Facts Supporting the Justification:

The facility's technical specifications are performance-based, describing the functional capabilities required for safe, continuous, and compliant laboratory operations, not a preference for any particular manufacturer. These include real-time auto-verification integrated with QC management across chemistry, hematology, immunoassay, coagulation, and microbiology, and automation functions supporting rapid sample intake, STAT routing, and multi-instrument orchestration. The facility also requires specialized capabilities such as sepsis-related biomarker reporting and high-resolution cellular analysis, along with continuity of the integrated middleware, interfaces, and verification workflows that support multiple laboratory sections. In the current marketplace, only one vendor has demonstrated the ability to meet all of these requirements without significant operational disruption, extended downtime, or duplicative cost.

Additionally, the awarded vendor must be capable of performing all tests on the facility's required test list. Based on information available to the facility, Abbott instrumentation does not perform B-type Natriuretic Peptide (BNP) testing; sites using Abbott platforms reportedly rely on a separate point-of-care instrument (I-STAT) to perform this test. If BNP is a required test, it should be performed on the primary automated platform to maintain the facility's auto-verification and QC workflow; the agency is confirming BNP's inclusion and annual volume for the official test list prior to finalizing this justification.

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:

The agency acknowledges that this action, together with the prior 2017 sole-source award, reflects continued reliance on a single source for this requirement. The agency intends to use the planned replacement of the automation line (documented replacement date May 18, 2027) as an opportunity to reassess market capability and competitive alternatives ahead of the next recompete of this requirement

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 sole source justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by GSAM/R 538.71 as directed by FAR 8.4.

Sharon Ford Lab Manager

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

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

Victoria Droz Contracting Officer

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

William Schlobohm Branch Chief, Services 5

HIGHER LEVEL APPROVAL (Required for orders over $900,000)

c. VHA RPO HCA Review and Approval (over $900,000 to $90 million): I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and approve for restricting consideration of the Federal Supply Schedule contractors to fewer than the number required by GSAM/R 538.71 ordering procedures as directed by FAR 8.4.

Brent Goe Acting Executive Director Head of Contracting Activity Regional Procurement Office-East