Redacted JA Flow Cytometry Testing Requirement.pdf

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Control Number: 25-MRCO-W-225

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JUNE 2025

JUSTIFICATION REVIEW DOCUMENT

FAR Part 13 Justification and Approval

Simplified Procedures for Certain Commercial Items

Program/Equipment: A Cost-Per-Test (CPT) Agreement for Flow Cytometry Testing at the Brooke Army Medical Center (BAMC), Fort Sam Houston TX for the Department of Pathology at Laboratory Services (OPALS), Core Laboratory.

Authority: Title 41 United States Code 1901(e)(2) as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items

Amount: $1.4 million (Base+ Four (4) Option years)

Base Period (1 October 2025 - 30 September 2026): $254,443.11

Option 1 (1 October 2026 - 30 September 2027): $267,165.27

Option 2 (1 October 2027 -30 September 2028): $280,523.53

Option 3 (1 October 2028 -30 September 2029): $294,549.71

Option 4 (1 October 2029 - 30 September 2030) $309,277.19 $1.4 million

NOTE: As a supply contract, Federal Acquisition Regulation (FAR) 52.217-8 is not available for use.

Prepared by: Medina Woodson Contract Specialist medina.l.woodson.civ@health.mil

Phone: (210) 539-8525 Date: 7/22/2025

Contracting Officer: Salameya Paulouskaya Phone: (210) 539-8656 Contracting Officer Date: 7/22/2025 salameya.paulouskaya2.civ@health.mil

Technical: CPT Darren Smith Deputy Chief, Core Laboratory darren.m.smith37.mil@health.mil

Requirements: LTC Ronald Henriquez

Chief, Core Laboratory Ronald.r.henriquez@health.mil

Phone: (210) 916-4845 Date: 7/22/2025

Phone: (210)-916-7793

Date: 7/15/25

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Reviews: I have reviewed this justification and find it adequate to support other than full and open competition.

Program Manager/Program Executive Officer:

LTC Carrie Graves Laboratory Manager

Phone: (210) 916-7793 h.mcarrie.l.graves2.mil@healtil

Small Business:

Mr. Jessie Keller Title: Small Business Specialist (Review only)

Phone: (210) 216-2657 jesse.l.keller6.civ@health.mil

Legal Counsel:

Ms. Jessica Volsey Associate General Counsel

Phone: (210) 816-1816 jessica.f.volsey.civ@h Ith.mil

GRAVES.CAR

LYNN.1236

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FAR Part 13 Justification and Approval Simplified Procedures for Certain Commercial Items

1. Requiring Activity: The Department of Pathology and Laboratory Services (OPALS), 3551 Roger Brooke Drive, JBSA Fort Sam Houston, Texas 78234.

2. Contracting Activity Medical Readiness Contracting Office, West (MRCO-W), 3551 Roger Brooke Drive, JBSA Fort Sam Houston, Texas 78234.

3. Description of Action: Request approval to award a new $1.4 million noncompetitive five-year (base and four one-year options to include a Firm-Fixed-Priced (FFP) definitive contract to Beckman Coulter, Inc., CAGE: 0HWD8, 250 S Kraemer Boulevard, Brea, California 92821-6232. The contract award will be subject to the availability of Defense Health Program, (DHP) FY26 funds.

4. Description of Supplies: This DPALS requirement is necessary to support the BAMC mission for a cost-per-test (CPT) agreement to conduct flow cytometry testing for the Centers for Disease Control (CDC) Basic Panel, Leukemia/Lymphoma, and Stem Cell/CD34. This requirement includes an In Vitro Diagnostic (IVD) cleared, FDA-approved Clinical Flow Cytometry Platforms and associated reagents and support services required for the Defense Health Agency (DHA) to accomplish the Flow Cytometry mission at BAMC.

Item Quantity Delivery Date

Estimated Unit Price

Estimated Value

Leukemia/Lymphoma 500 9/30/2026 $159.72 $BOK CDC Basic Panel 1250 9/30/2026 $127.87 $160K Stem Cell/CD34 90 9/30/2026 $135.02 $12K

Viability 59 9/30/2026 $44.04 $3K

Period Period of Performance (POP) Estimated Value Base Ordering

Period 01 October 2025 through 30-September 2026 $254K

Option 1 01 October 2026 through 30-September 2027 $267K Option 2 01 October 2027 through 30-September 2028 $281K Option 3 01 October 2028 through 30-September 2029 $295K Option 4 01 October 2029 through 30-September 2030 $309K Price Total Estimated Price $1.4M

5. Authority Cited: Title 41 U.S.C. §1901(e)(2) as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items

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6. Reason for Authority Cited: The Flow Cytometry Instrumentation must be able to have fully automated discrete random-access capabilities; be able to store reagents at the Food and Drug Administration (FDA) storage levels; be capable of barcode identification; be able to print patient results as one per page; have the ability to interface with the Military Health System (MHS) Genesis and the Risk Management Framework (RMF) and Health Insurance Portability and Accountability Act (HIPAA) compliant. Only one (1) vendor, Beckman Coulter, Inc, is authorized by the FDA to provide the CPT arrangement for a fully automated 10-color clinical flow cytometer analyzer that could meet the throughput required above for the DOD's only level 1 trauma center. Only Beckman Coulter, Inc can provide all the required reagents, and an FDA approved fully automated analyzer with flow cytometry capabilities that have the capacity to fulfill the estimated volume and perform the required testing mentioned above. Beckman Coulter, Inc. submitted a sole source letter on 11 June 2025 confirming that Beckman Coulter, Inc. is the only manufacturer, distributor and supplier for the reagent rental contracts for the iVD-cleared, FDA-approved Clinical Flow Cytometry Platforms and associated reagents and support services.

7. Efforts to Obtain Competition: The current market research dated 26 March 2025 consisted of the sources sought notice that was posted on 31 October 2024 with a response date of 14 November 2024. The only response was received from Beckman Coulter Inc. on 12 November 2024. The DPALS technical evaluator reviewed Beckman Coulter's capability statement and determined that this vendor meets the requirements for this action via email on 13 June 2025. The market research concludes that Beckman Coulter is the only vendor that is authorized by FDA to provide the flow cytometer that delivers the only FDA cleared and integrated leukemia and lymphoma solution, which offers all components needed, from quality controls, sample preparation and antibody panels to analysis software and ining material. This fully clinical flow cytometer analyzer will increase the testing efficiency by reducing the turnaround time and personnel required to complete this mission. Upon finalization of this Justification and Approval (J&A), The Contracting Officer will publish a notice of intent to sole source required by FAR 5.201 to the Government Point of Entry (GPE) site, https://sam.gov, with the final J&A to be published within 14 days of contract award.

a. DPALS confirmed through the FDA Device Registration that Beckman Coulter, Inc. is currently the only vendor that can provide an FDA approved flow cytometer with reagents. Beckman Coulter also submitted a sole source letter on 11 June 2025 confirming that their company is the only manufacturer, distributer and supplier for the reagent rental contracts for the IVD-cleared, FDA-approved Clinical Flow Cytometry Platforms and associated reagents and support services.

Therefore, it was determined through due diligence that competition for this effort was non-existent.

b. Subcontracting competition: For CPT Agreements, Beckman Coulter, Inc.

confirmed on 7 July 2025 that the vendor does not offer any subcontracting

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opportunities due to the internal reporting process required for this effort.

8. Actions to Increase Competition: Should BAMC continue to have a need for this testing beyond the conclusion of FY30, a sources sought notice will be posted to the GPE to continue to foster competition and ensure fair and reasonable pricing for any future effort.

9. Market Research: The market research began in October 2024 for the CPT Flow Cytometry requirement. The market research was conducted by DPALS personnel in conjunction with contracting personnel to determine the likelihood of other laboratory testing companies being able to provide for the complete requirement. The methods used included internet searches, a review of the College of American Pathologists' website, Electronic Cataloging (ECAT), General Service Administration (GSA) Federal Supply Schedule (FSS), and the Sources Sought Notice issued on https://sam.gov for a CPT Flow Cytometry requirement. DPALS confirmed that both GSA under Beckman Coulter Federal Supply Schedule (FSS) Number V7970-70260 and ECAT did not include all the flow cytometry reagents required for this effort. The response from the sources sought notice was received on 12 November 2024 resulted with only one capable vendor, Beckman Coulter, Inc. as listed above which concluded the market research after the submission of DPALS technical review of Beckman Coulter's capability statement on 13 June 2025.

10. Interested Sources: To date, there have not been any other interested sources that have written to express interest in the acquisition.

11. Other Facts:

a. Procurement history.

Contract Number Contractor Procurement Method Amount (est.)

Period of Performance

W81K00-23-P-0054 Sysmex America, Inc. Competitive Acquisition $302,762.00 01 October 2023 through 23 August 2024 - (Terminated for Default)

W81K00-22-P-0275 Beckman Coulter, Inc. Sole Source Acquisition $291,771.54 28 September 2022 through 30 September

W81K00-18-O-0004 Beckman Coulter, Inc. Competitive Acquisition $1,004,443.46 01 April 2018 through 30 September 2022

W81K00-12-P-0002 Beckman Coulter, Inc. Competitive Acquisition $1,001,694.00 23 May 2012 through 30 September 2016

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(1) Authority previously cited if less than full and open competition was used.

W81K00-22-P-0275 - FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

(2) If any prior contract for this requirement was accomplished using full and open competition or full and open competition after exclusion of sources, include a detailed explanation of the changed circumstances causing this action to now limit the sources. Purchase Order W81K00-23-P- 0054 was terminated for cause on 23 August 2024. The reason for termination for cause is Sysmex America, Inc's failure to accomplish Statement of Work (SOW), Specific Task 11.2. Sysmex could not complete the transition period for the Flow Cytometry Contract within the 90 days of contract award as stated in the SOW. In addition, Sysmex did not possess the FDA approval required by the Defense Health Agency for the fully automated clinical flow cytometer analyzer.

(3) An explanation of any unusual patterns that may be revealed by the history, e.g., several consecutive, urgent buys - N/A.

(4) An explanation of protests received, if applicable, and actions taken in response to the protest. The Government received a protest for Purchase Order W81K00-23-P-0054 by the Vendor, Beckman Coulter, Inc., on 28 July 2023. Beckman Coulter, Inc., of Indianapolis, Indiana, submitted a protest for the award of a contract to Sysmex America, Inc., of Lincolnshire, Illinois, under request for quotations (RFQ) No.

W81K00- 22- Q-0109, issued by the Department of the Army, Army Medical Command, for laboratory equipment and maintenance services for the Flow Cytometry Testing. The protestor alleged that the award was improper because the awardee, Sysmex America, Inc did not have FDA- cleared Flow Cytometry testing equipment and should have been found to be technically unacceptable. The contracting officer informed the protester that the Procurement Integrity Act precluded the agency from providing any additional information about the content of the awardee's quotation.

After this discussion, on 19 May 2023 the protester filed an agency-level protest with the Army. On 6 June 2023, the agency dismissed the protest as untimely because the protest had been filed more than 10 days after the protester knew or should have known the basis of its protest. On 13 June 2023, the protester filed this protest with the United States Government Accountability Office (GAO). On 28 July 2023, the GAO dismissed the Protest as untimely.

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b. Other facts. On 11 June 2026 Beckman Coulter provided a statement that they do not have any known distributors or other authorized vendors that could provide the FDA approved fully automated clinical flow cytometer analyzer.

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

CPT Darren Smith Deputy Chief, Core Laboratory

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

LTC Ronald Henriquez Chief, Core Laboratory

HENRIQUEZ.RONA Digitally signed by

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14. Fair and Reasonable Cost Determination: I hereby determine that the anticipated price/cost to the Government for this contract action will be fair and reasonable. This determination will be made using price analysis in accordance with the Federal Acquisition Regulations (FAR) 15.404-1 Price Analysis. The Proposed pricing will be compared to the IGE, which was prepared prior to seeking formal proposals, competitive published price lists, historical pricing and utilizing market research for the same or similar items.

Salameya Paulouskaya Contracting Officer

15. Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Salameya Paulouskaya Contracting Officer

PAULOUSKAYA.SAL Digitally signed by

07.31 15:03:06 -05'00'

SALAMEYA.12

035373

Digitally signed by

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JUNE 2025

Approval

Based on the foregoing justification, I hereby approve the procurement of a CPT Agreement for Flow Cytometry Testing on an other than full and open competition basis pursuant to the authority of Title 41 U.S.C. §1901(e)(2) as implemented in FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items. The estimated value of the new contract is $1.4 million for a five-year (base and four one-year options with an ordering period from 01 October 2025 to 30 September 2030. The approval is subject to availability of funds, and provided that the supplies herein described have otherwise been authorized for this acquisition.

SIMMONS-

CARROLL.CICEL Y.D.138161

lly signed by SIMMONS-

025.08.01 07:44:08 -05'00'

Cicely D. Simmons-Carroll Advocate for Competition