Redacted JA Sole Source - CLIA Reagents -- Fully Executed - 2 April 2025 (005).pdf

CUI//SP-SSEL

Control Number: 25-MRCO-W-98

CUI//SP-SSEL

(Source Selection Information - See FAR 2.101 and 3.104-4)

1 JUN 2023

Justification Review Document For Sole Source - FAR Part 13.501*

(*Format follows FAR 6.303-2, but modified to reflect FAR subpart 13.5 procedures)

Program/Equipment: The Department of Pathology and Area Laboratory Services (DPALS) seeks to establish a cost-per-kit agreement to include reagents, consumables, controls, and any necessary products to conduct testing to include: Calprotectin, Cytomegalovirus, Epstein-Barr virus (viral capsid antigens, nuclear antigens, and early antigen-diffuse), Herpes Simplex Virus ½, Measles, Mumps, Rubella, Toxoplasma gondii, Varicella Zoster, Zika virus, Lyme disease, and an assay capable of rapidly differentiating between bacterial and viral infections in acute settings (MeMed BV or similar) compatible with the government’s current Diasorin Liaison XL Chemiluminescence Immunoassay (CLIA) instrumentation for the Department of Pathology & Area Laboratory Services Molecular Laboratory at Brooke Army Medical Center (BAMC), Fort Sam Houston TX.

Authority: 41 United States Code 1901 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: $5,640,183.50 (Base + Four (4) Option years)

Prepared by:

Medina Woodson Date: 21 February 2025 Contract Specialist medina.l.wooson.civ@health.mil

Contracting Officer:

Salameya Paulouskaya Date: 21 February 2025 Contracting Officer:

salameya.paulouskaya2.civ@health.mil mailto:medina.l.wooson.civ@health.mil mailto:salameya.paulouskaya2.civ@health.mil

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2 JUN 2023

Technical Representative:

CPT Amina Zeidan Date: 21 February 2025 OIC, Immunology & Molecular Diagnostics (210) 916-0717 Department of Pathology and Area Laboratory Services Brooke Army Medical Center amina.r.zeidan.mil@health.mil

Requirements Representative:

Ms. Marisa Fernandez Date: 3 March 2025 Supervisor, Immunology & Molecular Diagnostics (210) 916-9944 Department of Pathology and Area Laboratory Services Brooke Army Medical Center marisa.p.ffernandez.civ@health.mil

Reviews

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

YOON.FRAN Digitally signed by

YOON.FRANK.1238380274

K.1238380274 Date: 2025.04.02 14:25:03 -04'00'

Mr. Frank Yoon Date: see digital signature Associate General Counsel Contract Law MTF Support Branch Defense Health Agency frank.yoon.civ@health.mil mailto:amina.r.zeidan.mil@health.mil mailto:marisa.p.ffernandez.civ@health.mil mailto:frank.yoon.civ@health.mil

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3 JUN 2023

Sole Source Justification and Approval Under FAR 13.501

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

2. Description of Action: DPALS at BAMC requests a contract for the purchase of a cost-per-kit agreement to include CLIA Testing reagents, consumables and controls compatible with the government’s current Diasorin Liaison XL CLIA instrumentation via a firm fixed price contract. The Government projects award before 30 September 2025, with performance to start 1 October 2025; award will be subject to the availability of Defense Health Program, (DHP) FY26 funds. An acquisition plan is not required because this procurement does not meet the threshold at Defense Federal Acquisition Regulation Supplement 207.103(d)(i)(B).

Name of Proposed Contractor and Address:

Diasorin, Inc.

1951 Northwestern Avenue Stillwater, MN 55082 CAGE Number: 1KF01 SAM UEI: Number: FGK2QR959BV5

3. Description of Supplies/Services: The Government’s requirement is to establish a cost-per-kit agreement to include reagents, consumables, controls, and any necessary products to conduct testing to include: Calprotectin, Cytomegalovirus, Epstein-Barr virus (viral capsid antigens, nuclear antigens, and early antigen-diffuse), Herpes Simplex Virus ½, Measles, Mumps, Rubella, Toxoplasma gondii, Varicella Zoster, Zika virus, Lyme disease, and an assay capable of rapidly differentiating between bacterial and viral infections in acute settings (MeMed BV or similar).

ASSAY/TEST (BASE YEAR) (OPTION 1) (OPTION 2) (OPTION 3) (OPTION 4)

CMV IGG 700 700 700 700 700

CMV IGM 700 700 700 700 700

CALPROTECT 2,800 2,800 2,800 2,800 2,800

MEMED BV 9,400 9,400 9,400 9,400 9,400

EBV IGM 800 800 800 800 800

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VCA IGG 800 800 800 800 800

EBNA IGG 800 800 800 800 800

EA IGG 800 800 800 800 800

HSV-1 IGG 800 800 800 800 800

HSV-2 IGG 800 800 800 800 800

MEASLES IGG 2,800 2,800 2,800 2,800 2,800

MUMPS IGG 2,800 2,800 2,800 2,800 2,800

RUBELLA IGG 2,800 2,800 2,800 2,800 2,800

RUBELLA IGM 2,800 2,800 2,800 2,800 2,800

TOXO IGG 600 600 600 600 600

TOXO IGM 600 600 600 600 600

TREPONEMA 12,600 12,600 12,600 12,600 12,600

VZV IGG 2,800 2,800 2,800 2,800 2,800

ZIKA IGM 800 800 800 800 800

LYME IGM 400 400 400 400 400

LYME IGG 400 400 400 400 400

LYME TOTAL 400 400 400 400 400

Delivery Period: 1 October 2025 to 30 September 2030

Amount: $5,640,183.50 (Base + Four (4) Option years)

Base Period (1 October 2025 – 30 September 2026): $1,020,731.07 Option 1 (1 October 2026 – 30 September 2027): $1,071,767.62 Option 2 (1 October 2027 – 30 September 2028): $1,125,356.00 Option 3 (1 October 2028 – 30 September 2029): $1,181,623.80 Option 4 (1 October 2029 – 30 September 2030): $1,240,705.00

$5,640,183.50

NOTE: As a supply contract, FAR 52.217-8 is not available for use.

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5 JUN 2023

4. Authority Cited: 41 United States Code 1901 as implemented in Federal Acquisition Regulation 13.501(a)(1)(ii), sole source (including brand name) under the authority exceeding the simplified acquisition threshold for simplified procedures for certain commercial items.

5. Reason for Authority Cited: The CLIA infectious disease testing aids clinicians in the timely diagnosis and monitoring of both acute and chronic infections that can cause increased morbidity and mortality. This method can replace previous laboratory testing methodologies that are slower and require larger patient samples and more consumables (chemicals, etc.), to complete. Utilizing CLIA technology produces more reliable test results and allows the lab to run more patient samples in a shorter amount of time, improving patient care and reducing laboratory technician workload per shift.

This reagent testing listed above is currently being performed in house except for Calprotectin, Zika, and MeMed BV assays which are being performed externally through LabCorp Laboratory. DPALS has validated the preferred testing method, chemiluminescent immunoassay (CLIA), and is now in need of reagents that can be tested under this methodology. The Immunology laboratory system has already converted to accommodate the CLIA testing methodology so that all testing can be completed in-house. The current contract does not meet all of DPALS contract needs and will be discontinued this year and, fully replaced by this contract.

DPALS currently has Diasorin Liaison XL CLIA instrumentation which is owned by the government. Diasorin, Inc. (Diasorin) is the only vendor that is Food and Drug Administration (FDA) approved that offers the LIASON® MeMed BV® and the simplified specialty testing that is fully automated and compatible with the government’s current Diasorin Liaison XL CLIA instrumentation. Diasorin, Inc submitted a sole source letter on 26 February 2025 confirming that Diasorin is the sole manufacturer, distributer, and supplier of record for the LIASON® MeMed BV®, the only automated, high throughput version of the MeMed BV® assay. MeMed (bacterial and viral infection calculation test for emergency room providers) is only available through this vendor – they have the patent and FDA approval, and no other vendor offers any version of this test type; it is unique to Diasorin as the only distributor.

6. Efforts to Obtain Competition: The current market research dated 28 February 2025 consisted of the sources sought notice that was posted on 6 January 2025 with a response date of 16 January 2025. The only response was received from Diasorin, Inc.

on 15 January 2025. DPALS technical evaluator reviewed Diasorin’ s capability statement and determined that this vendor meets the requirements for this action via email on 17 January 2025. The market research concludes that Diasorin is the only vendor that is authorized by FDA to provide the cost-per-kit agreement that includes the MeMed BV® assay that can meet the high throughput required by utilizing the CLIA Methodology which 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), a notice of intent to sole source will be posted to the Government

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6 JUN 2023

Point of Entry (GPE) site, https://sam.gov, with the final J&A to be published within 14 days of contract award.

7. 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.

8. Market Research: The market research began on October 2024 for the CLIA Reagents. 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 CLIA reagents. DPALS confirmed that both GSA under Diasorin Federal Supply Schedule (FSS) Number 47QSWA21D000G and ECAT did not include all the CLIA reagents required for this effort. The response from the sources sought notice was received on 15 January 2025 resulted with only one capable vendor, Diasorin, Inc. as listed above which concluded the market research after the submission of DPALS technical review of Diasorin’ s capability Statement on 17 January 2025.

9. Interested Sources: A Sources Sought Notice was posted to https://sam.gov, the official GPE, on 06 January 2025 with a response due date of 16 January 2025 in order to find companies (small and other-than-small) that could provide an FDA Approved testing reagents compatible with the government’s Diasorin Liaison XL Instrumentation. The only response was received from Diasorin on 15 January 2025. Based on DPALS technical review of Diasorin’ s capability statement on 17 January 2025, it has been determined by DPALS that this vendor meets the requirements for this effort. To date, there have not been any other interested sources that have written to express interest in the acquisition.

10. Other Facts:

a. Procurement history.

(1) Contract numbers and dates of all awarded contracts for the same requirements:

W81K00-23-P-0262 was awarded to Government Scientific Source Inc. on 13 September 2023 with a base period from 01 October 2023 to 30 September 2024 plus four (4) twelve (12) month option periods from 1 October 2024 thru 30 September 2028.

W81K00-18-P-0274 was awarded to Government Scientific Source Inc. on 18 April 2018 with a base period from 01 October 2018 to 30 September 2019

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7 JUN 2023

plus, four (4) twelve (12) month option periods from 1 October 2019 thru 30 September 2023.

W81K00-17-P-0763 was awarded to Government Scientific Source Inc. on 29 September 2017 for the period of performance from 01 October 2017 to 30 September 2018.

(2) Competitive status:

W81K00-23-P-0262, competitive acquisition W81K00-18-P-0274, a sole source acquisition W81K00-17-P-0763, small business set-aside competitive acquisition

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

W81K00-18-P-0274 - FAR 13.501(a)(1)(ii), sole source (including brand name) under the authority of the simplified procedures for certain commercial items.

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results – N/A

(5) If any prior contract for this requirement was accomplished using full and open competition, include a detailed explanation of the changed circumstances causing this action to now limit the sources – DPALS Immunology Laboratory is converting their testing methodology to now accommodate CLIA Capabilities for efficient and more reliable test results.

This testing methodology allows the laboratory to run more patient samples in a shorter amount of time, improving patient care and reducing laboratory technician workload per shift. In addition, Diasorin is the only vendor that offers the FDA approved LIASON® MeMed BV® and the simplified specialty testing that is fully automated and compatible with the government’s current Diasorin Liaison XL CLIA instrumentation.

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

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the procurement and whether there have been any significant changes – N/A.

b. Other facts. Diasorin does not have any known distributors or other authorized vendors that could provide the MeMed BV® Reagent Test.

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8 JUN 2023

11. 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.

ZEIDAN.AMINA.

Digitally signed by

ZEIDAN.AMINA.RAL.1108297936

RAL.1108297936 Date: 2025.04.01 13:41:20 -05'00'

CPT Amina Zeidan Date: see digital signature OIC Immunology & Molecular Diagnostics

12. 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.

Digitally signed by

FERNANDEZ.MARISA.P.136653

Date: 2025.04.01 16:48:55 -05'00'

Ms. Marisa Fernandez Date: see digital signature Supervisor, Immunology & Molecular Diagnostics

13. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable.

PAULOUSKAYA.SA Digitally signed by

LAMEYA.12460353 PAULOUSKAYA.SALAMEYA.124

73 Date: 2025.04.02 13:11:32 -05'00'

Salameya Paulouskaya Date: see digital signature Contracting Officer

14. Contracting Officer Certification:

I certify that this justification is accurate and complete to the best of my knowledge and belief.

PAULOUSKAYA.SA Digitally signed by

LAMEYA.12460353 PAULOUSKAYA.SALAMEYA.124

73 Date: 2025.04.02 13:11:46 -05'00'

Salameya Paulouskaya Date: see digital signature Contracting Officer

FERNANDEZ.MAR

ISA.P.1366533520

6035373

6035373

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9 JUN 2023

Approval

Based on the foregoing justification, I hereby approve the procurement of cost-per-kit agreement to include reagents, consumables, controls, and any necessary products to conduct testing in support of the Department of Pathology and Area Laboratory Services, for the estimated dollar value of $5,640,183.50, on an other than full and open competition basis pursuant to the authority of 41 U.S.C. 1901 as implemented by FAR 13.501, subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.

SIMMONS-

Digitally signed by SIMMONS-

CARROLL.CICELY. CARROLL.CICELY.D.138161264

D.1381612640 Date: 2025.04.02 14:42:44 -05'00'

Cicely Simmons-Carroll Date: see digital signature Command Advocate for Competition