Limited Sources Justification (LSJ) Urinalysis Analyzers Eglin AFB CO signed Final REDACTED.pdf

Control Number: FY25-0269

OCT 2024

Limited Sources Justification (LSJ) Federal Acquisition Regulation (FAR) 8.405-6(a)(1)(i)(B)

1. Identification of the Agency and Contracting Activity:

Defense Health Agency (DHA), Healthcare Contracting Division - South

2. Nature and/or Description of Action being Approved:

This Limited Sources Justification is to establish a new one (1) year plus four (4) options, Firm Fixed Price contract with Beckman Coulter (CAGE: 0HWD8) for two (2) identical, integrated DxU 840 Iricell urinalysis analyzers (DxU 840) in support of the 96th Medical Group (MDG) laboratory located at Eglin AFB, Florida. This action will be utilizing the vendor’s Veteran Affairs Federal Supply Schedule V797D-70260. The delivery order includes a base year and four (4) option years with a total estimated value of $.

3. Description of Supplies or Services and Estimated Value:

96th Medical Group (MDG) laboratory is requesting a new requirement to provide and deliver, on a lease basis, two (2) DxU 840 integrated urinalysis analyzers with Risk Management Framework (RMF) approved middleware capable of performing 4,125 total urine, microscopy and automated cell counts on cerebrospinal fluid, peritoneal fluid, and synovial fluid samples per month in order to support the 96th Medical Group (MDG) laboratory. The urinalysis analyzers must have capacity to perform an average of 49,500 tests annually. These tests are critical for the management, diagnosis, and treatment of various diseases and infections, as well as for the medical readiness of patients located at Eglin, AFB Florida. The contractor shall provide and deliver all labor, materials, equipment, preventative maintenance of equipment, correlation and validation testing, training, transportation, installation/removal of equipment and major/incidental repair services of equipment in accordance with the Statement of Work.

Period Period of Performance Estimated Value Type of Funding Base Period 01 OCT 2025 – 30 SEP 2026 O&M Option Period 1 01 OCT 2026 – 30 SEP 2027 O&M Option Period 2 01 OCT 2027 – 30 SEP 2028 O&M Option Period 3 01 OCT 2028 – 30 SEP 2029 O&M Option Period 4 01 OCT 2029 – 30 SEP 2030 O&M

FAR 52.217-8 N/A N/A

Total

4. Authority Cited: FAR 8.405-6(a)(1)(i)(B)

5. Rationale Justifying Use of Authority Cited:

96th Medical Group (MDG) requests the use of a sole source justification IAW FAR 8.405- 6(a)(1)(i)(B), to provide and deliver, on a lease basis, two (2) identical, integrated Beckman Coulter DxU 840 urinalysis analyzers with Risk Management Framework (RMF) approved middleware to include all reagents, consumables and supplies to support approximately 49,500 test per year. The requirement necessitates an award to Beckman Coulter, Inc., the Original Equipment Manufacturer (OEM), as the Coulter Analyzer DxU 840 urinalysis analyzers possesses the unique characteristics outlined below.

The Government requires the urinalysis analyzer platform with the following critical characteristics:

- Integrated Urinalysis Analyzers with Risk Management Framework (RMF) approved middleware capable of user defined rules to facilitate auto-validation of normal patient results into LIS and manage all components of their solution. The fully operation interface (both hardware and software) must be immediately available for implementation to the hospital information system.

- Middleware with Auto-Verification Capability: The system includes middleware with auto-verification capabilities, which streamlines the validation processes, reduces errors, and improves overall laboratory efficiency.

- The system must provide the following reportable parameters: Glucose, Protein, Bilirubin, Urobilinogen, pH, Specific Gravity, Blood, Ketones, Nitrite, Leukocyte, Color, Clarity, Color Compensation Pad, RBC, WBC, WBC Clumps, Squamous Epithelial Cells, Non- Squamous Epithelial Cells, Hyaline Casts, Unclassified Casts, Crystals, Bacteria, Yeast, Sperm, and Mucus. The system must provide additional categories for sub-classification of unclassified casts (Granular, Cellular, Waxy, Broad, RBC, Epithelial Cell, and Fatty Casts).

The system must also provide additional categories for sub-classification of crystals (Calcium Phosphate, Uric Acid, Calcium Carbonate, Leucine, Cystine, Tyrosine, Amorphous, Calcium Oxalate, and Triple Phosphate).

- The system must feature body fluid analysis including microscopic portion of analysis. The system must provide an achievable record of what was seen, is linear down to zero, and must require very low specimen volume.

- Analyzer must have sample throughput of at least 70 samples per hour for automated urine microscopy and over 200 samples per hour for automated urine chemistry to meet current workload needs. It must have the ability to load multiple samples at once for a minimum of

50 samples with continuous feeds and the user can start the instrument and walk away during instrument analysis.

- Food and Drug Administration (FDA) approved

- The analyzer must perform automated cell counts on cerebral spinal fluid, peritoneal fluid, and synovial fluid.

- Bi-directional, bar-coded interface. The analyzer(s) must be bi-directional interfaced to MGS Genesis (must be able to download test orders and patient demographics from host computer and integrate this information with test results for certifying the results in host computer).

The DxU 840 Iricell urinalysis analyzer (DxU 840) with the Remisol Advance Middleware is capable of testing all the required reportable parameters, has a current ATO, uses FDA approved equipment and reagents, and conducts testing within the required sample throughput. The DxU 840 also has a bidirectional, bar-coded interface to MHS Genesis, and meets all other Government specifications. It is evident through market research that there are alternative urinalysis analyzers in the commercial marketplace, such as urinalysis equipment from Roche Diagnostics and Sysmex. The 96th Medical Group laboratory reviewed other urinalysis analyzers and products with similar attributes of integrated urinalysis platforms and approximate size/sample test volumes. Results concluded that the products reviewed from these various other manufacturers stated above could not perform the necessary testing required by the Government or were not FDA approved.

Furthermore, Beckman Coulter, Inc. is the original manufacturer and sole vendor for the Beckman Coulter DxU 840, analyzers, reagents, consumables and maintenance; therefore, the technical specifications of the items are proprietary and are only available from the manufacturer. The associated technical specifications of the products cannot be made available to other sources in the commercial marketplace since the Government and/or other commercial entities do not own or have legal access to the intellectual property owned by Beckman Coulter, Inc.

6. Market Research:

Market research was conducted utilizing Sam.gov, FPDS-NG.gov, GSA Advantage and other Government/commercial sources in order to locate alternative brands and/or sources to support the supplies required at the level and quality required by the Government. Other manufacturers/brands for urinalysis analyzers and associated products were identified via market research; however, due to the aforementioned critical characteristics, deviation from the Beckman Coulter DxU 840 analyzers would be detrimental to the Government's need.

The Military Treatment Facility – Laboratory Subject Matter Expert (SME) initially reviewed three (3) potential solutions from Roche Diagnostics Corp, Sysmex America, Inc., Inc and Beckman Coulter, Inc. Results of the initial review are as follows:

Roche Diagnostics:

Roche offers the cobas u 601, which provides reliable urinalysis testing. However, it does not include automated microscopic analysis for body fluids such as cerebrospinal fluid, peritoneal fluid, and synovial fluid. This limitation makes it less suitable for the comprehensive testing required.

Sysmex:

Sysmex provides the UN-Series, which includes the UN3000 analyzer for urinalysis. However, the proposed system does not support automated cell counts on cerebrospinal fluid, peritoneal fluid, and synovial fluid. This limitation makes Sysmex less suitable for the 96 MDSS/Laboratory’s requirements.

Beckman Coulter:

Beckman Coulter offers the DxU 840, which provides high throughput with advanced automation and accurate testing capabilities for urine and body fluids. The DxU 840 is equipped with Remisol middleware for auto-verification and offers seamless integration with MHS Genesis, providing comprehensive technical support and ensuring minimal downtime. It also handles a wide range of body fluids, including cerebrospinal fluid, peritoneal fluid, and synovial fluid.

Additionally, a Request for Information - Sources sought (RFI-SS) was posted on the Government Point of Entry, Sam.gov, on 18 April 2025 with a closing date of 01 May 2025 searching for small businesses that are capable of providing the Government’s requirement.

Reference RFI – SS identification number “HT9408-25-UA.” The Government received three

(3) industry responses to the RFI – SS as follows:

1.) Beckman Coulter, Inc.

2.) Sysmex America, Inc.

3.) BHPE LLC

BHPE did not provide any documentation for the Government to review, so no further consideration was taken with that firm.

Both Beckman Coulter Inc. and Sysmex America, Inc. provided potential solutions to meet the Government’s need, which was evaluated by the Government as follows:

Sysmex America, Inc

Sysmex does not meet the minimal requirements as outlined in the Statement of Work.

Proposed analyzers are not FDA-cleared to run body fluids on the UF5000. This can lead to inaccurate results, potentially leading to misdiagnosis, inappropriate treatment, and patient harm.

Adherence to Clinical Laboratory Improvement Amendments (CLIA) and FDA requirements is essential for laboratory operations. Performing on non-FDA-cleared analyzers result in non-compliance and jeopardize accreditation status.

Beckman Coulter, Inc.

Solution met the Government’s minimum requirement.

7. Other Facts:

a. Procurement history.

(1) Is this a new requirement? Yes

(2) If 7.a.(1) is No, was the action just prior to this one competed? N/A

(3) If 7.a.(2) is Yes, what has changed where this action cannot be competed? N/A

b. Additional Information. N/A

8. Actions to Remove or Overcome any Barrier to Competition:

The MTF located at Eglin AFB, Florida will continue to evaluate other products capabilities from other distributors through continuing market research. Additionally, if the Government's requirement changes in the future, the intent of the Government is to issue a full and open competitive solicitation in order to provide the greatest amount of competition as practicable. Continued efforts in this regard will ensure that Government is receiving the best value at a fair and reasonable price by ensuring the Government utilizes the most efficient and economical means possible. The Government will issue a notice of award to include the justification to sole source this action on the Government Point of Entry website, Contract Opportunities, to encourage small business participation and foster competition.

9. Technical Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Marcus Mattingly Contracting Officer Healthcare Contracting Division - South

Chief, Laboratory Quality Assurance/Regulatory Compliance 96th Medical Group

10. Requirements Certification:

I certify the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Chief, Laboratory Quality Assurance/Regulatory Compliance 96th Medical Group

11. Best Value Determination:

Consistent with FAR 8.404(d) Pricing and supplemental Department of Defense requirements, I hereby determine the action described herein represents the best value to the Government.

Basis for Determination: FAR 8.404(d) (Pricing).

MATTINGLY.MARCU

S.HAY.1295235507

Digitally signed by

MATTINGLY.MARCUS.HAY.12952

35507 Date: 2025.07.14 13:37:58 -05'00'

12. Legal Review:

I have reviewed this justification and have found it to be legally sufficient.

Marcus Mattingly Contracting Officer Healthcare Contracting Division - South

Attorney Office of General Counsel

13. Contracting Officer Certification:

I certify this justification pursuant to the authority of FAR 8.405-6 (d) Justification Approvals is accurate and complete to the best of my knowledge and belief.

MATTINGLY.MARCU

S.HAY.1295235507

Digitally signed by

MATTINGLY.MARCUS.HAY.12952

35507 Date: 2025.07.14 14:12:17 -05'00'