FY24_JA Sole Source______________Human Serum PlasmaTesting_Abbott Laboratories_ Redacted.pdf

Control #: 24-RHCO-C-363 Contractor: Abbott Laboratories Program/Equipment: Human Serum/Plasma Testing

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

Sole Source Justification and Approval Review Document

Under FAR 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) seek to establish a cost-per-test (CPT) arrangement to include reagents, consumables, and controls compatible with the Abbott Alinity instrumentation currently in use on Purchase Order W81K00-22-P-0154 with Abbotts Laboratories to conduct chemiluminescent microparticle immunoassay (CMIA) testing for the presence of protein markers in human serum and plasma that indicate the presence of traumatic brain injury protein markers (glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in support of DPALS at the 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: $491,206.52 (Base + Four (4) Option years)

A 5.00% escalation increase was added for each four (4) twelve (12) month option year from 01 October 2025 to 30 September 2029 to account for the cost of inflation in the market for the Human Serum/Plasma Testing.

Prepared by: Title: Contract Specialist:

Date: 21 August 2024

Contracting Officer:

Date: 21 August 2024 Email:

: Email

Base Period (1 October 2024 – 30 September 2025):

Option 1 (1 October 2025 – 30 September 2026):

Option 2 (1 October 2026 – 30 September 2027):

Option 3 (1 October 2027 – 30 September 2028):

Option 4 (1 October 2028 – 30 September 2029):

$491,206.5 mailto:medina.l.wooson.civ@health.mil mailto:Salameya%2Cpaulouskaya2.civ@health.mil mailto:Salameya%2Cpaulouskaya2.civ@health.mil

Program/Equipment: Human Serum/Plasma Testing

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Technical Representative: DSN: (210) 916-0717

Typed Name:

Title: OIC, Immunology & Molecular Diagnostics Date: 21 August 2024

E-mail:

mailto:amina.r.zeidan.mil@health.mil mailto:amina.r.zeidan.mil@health.mil

Program/Equipment: Human Serum/Plasma Testing

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Sole Source Justification and Approval

Under FAR 13.501

1. Contracting Activity: Joint Base San Antonio Health Contracting Branch (JBSA HCB), Medical Readiness Contracting Office, West (MRCO-W) US Army Health Contracting Activity, 3551 Roger Brooke Drive, JBSA Fort Sam Houston, Texas 78234.

2. Description of Action: DPALS at BAMC requests the purchase of human serum plasma testing reagents and consumables on a CPT agreement via a firm fixed price contract. The Government projects award before 30 September 2024, with performance to start 1 October 2024; award will be subject to the availability of Defense Health Program, (DHP) FY25 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:

Abbott Laboratories

3. Description of Supplies/Services: The Government’s requirement is to establish an CPT arrangement to include reagents, consumables, and controls to conduct chemiluminescent microparticle immunoassay (CMIA) testing for traumatic brain injury protein markers (glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) in support of DPALS at BAMC, Fort Sam Houston, TX. The CPT Arrangement will provide the necessary reagents, standards, quality controls, consumables/disposable items, and any other element necessary (to exclude instrumentation) for the proper functioning of the government`s equipment required for the generation of a reportable result which allows the laboratory to efficiently analyze the products and derivatives to produce the patients results. All testing will be performed in-house at BAMC.

A CMIA test has been recently approved by the Federal Drug Administration (FDA) to aid in the clinical diagnosis of traumatic brain injury (TBI) in those presenting as “mild”, “borderline”, or otherwise hold a suspicion of TBI. The assay measures two protein marker levels, glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase L1 (UCH-L1) to determine whether patients can be ruled out for having TBI or should follow standard TBI clinical algorithms to include computed topography (CT) scans and additional medical care. The implementation of this test would allow for TBI diagnosis in under one hour, specifically, the test can be completed in under 18 minutes once in laboratory. Utilization of this new tool would help reduce unnecessary CTs in emergency settings, while also prioritizing TBI cases that may not present as “classic”

Program/Equipment: Human Serum/Plasma Testing

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TBI. Overall, we expect improved quality of life, decreased costs, and reduction in long-term morbidity and mortality due to misdiagnosed TBI and delayed TBI care. BAMC would serve as the first Military Treatment Facility (MTF) to implement this test, remaining at the forefront of care for both service members and civilians. BAMC’s implementation of this breakthrough testing would pave the way for other MTFs to improve TBI care across the globe.

The reagents described above should provide the quantitative, or semi-quantitative determination of:

glial fibrillary acidic protein ubiquitin carboxyl-terminal hydrolase L1

The assay results, in conjunction with other laboratory results and clinical information, are to aid in the diagnostic need for computed topography (CT) scan and further gold standard clinical evaluation for traumatic brain injury. In order to be able to conduct these tests, reagents and consumables are needed for period of performance 1 October 2024 to 30 September 2025 with four (4) option years 1 October 2025 thru 30 September 2029. All equipment and supplies must be approved by the Food and Drug Administration (FDA). The system is FDA Approved Guided programming. This requirement is needed NLT 1 October 2024. All detailed information regarding delivery and performance is provided in the Statement of Objectives (SOO).

Estimated volume of the reagents on a yearly basis are as follows:

TYPE OF

TEST

(BASE

YEAR)

(OPTION 1)

(OPTION 2)

(OPTION 3)

(OPTION 4)

GFAP 2,400 tests per year

2,400 tests per year

2,400 tests per year

2,400 tests per year

2,400 tests per year

UCH-L1 2,400 tests per year

2,400 tests per year

2,400 tests per year

2,400 tests per year

2,400 tests per year

Delivery Period: 1 October 2024 to 30 September 2029

Amount: $491,206.51 (Base + Four (4) Option years)

Base Period (1 October 2024 – 30 September 2025):

Option 1 (1 October 2025 – 30 September 2026):

Option 2 (1 October 2026 – 30 September 2027):

Option 3 (1 October 2027 – 30 September 2028):

Option 4 (1 October 2028 – 30 September 2029):

Program/Equipment: Human Serum/Plasma Testing

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

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: Abbott Laboratories is the only vendor that is FDA approved that offers the Alinity ci analyzer under the Federal Supply Schedule 36F797-19-D0024 as Cost Per Test or Cost Per Reportable Result pricing structure including costs covering all equipment use, reagents, calibrators, controls, parts, service, and any accessories necessary to report a result where the equipment title remains with Abbott for the term of the agreement. This vendor submitted a sole source letter on 13 February 2024 confirming that Abbott Laboratories is the legal manufacturer of record for the Alinity clinical chemistry and immunoassay analyzer system. The reagents, calibrators, and controls for both assays in the mTBI panel, GFAP and UCH are registered with Abbott Diagnostics which is a division of Abbott Laboratories. Abbott Laboratories is the ultimate parent for Abbott Laboratories. This Contractor do not presently have any authorized resellers or distributors to the Defense Health Agency for the above mentioned items.

Only Abbott Laboratories can provide all the required reagents under chemiluminescent immunoassay methodologies and perform the required testing mentioned above. This testing will allow BAMC to be the first Military Treatment Facility to implement a potential updated standard of care for treating traumatic brain injury in both soldiers and civilians. Utilizing this test would allow emergency providers to better categorize and prioritize certain TBI patients, allowing for better quality of care and improved health outcomes for patients.

6. Efforts to Obtain Competition: This is a new requirement for a CPT Agreement to include reagents, consumables, and controls to conduct CMIA testing for the presence of protein markers in human serum and plasma that indicate the presence of traumatic brain injury. The current market research has confirmed that Abbott Laboratories is the only vendor that is authorized by FDA to provide the CPT arrangement and could meet the throughput required for Department of Defense’s (DOD) only level 1 trauma center.

Should BAMC continue to have a need for these reagents at the conclusion of the last option period, a sources sought notice will be posted to the GPE to determine if there are any new entrants to the marketplace that are FDA approved. The Contracting Officer shall publish the notices required by FAR 5.201. A Sources Sought Notice was posted on 5 March 2024 with a response date of 20 March 2024. Upon finalization of

Program/Equipment: Human Serum/Plasma Testing

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this Justification and Approval Document, a notice of intent to sole source will be posted to the GPE 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 FY29, a sources sought notice will be posted to the Government Point of Entry (GPE) to continue to foster competition and ensure fair and reasonable pricing for any future effort.

8. Market Research: Prior to the posting of the sources sought notices, 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 as well as Electronic Cataloging (ECAT) and the General Service Administration (GSA) Federal Supply Schedule (FSS) for human serum/plasma reagents. DPALS confirmed that both GSA under Abbott Laboratories Federal Supply Schedule (FSS) 36F79719D0024 and ECAT did not include all the TBI reagents required for this effort. The Market Research for this requirement was conducted from October 2023 to March 2024.

A Sources Sought Notice was posted to https://sam.gov, the official GPE, on 05 March 2024 with a response due date of 20 March 2024 in order to find companies (small and other-than-small) that could provide an FDA Approved human serum/plasma testing reagents compatible with the Abbott Alinity instrumentation. The only response was received from Abbott Laboratories on 20 March 2024. Based on DPALS technical review of Abbott’s Capability Statement on 26 July 2024, it has been determined by DPALS that this vendor meet their requirements.

9. Interested Sources: To date, not aware of any other interested sources that have written to express interest in the acquisition.

10. Other Facts:

a. Procurement history.

(1) This is a new requirement for a CPT Agreement to include reagents, consumables, and controls to conduct CMIA testing for the presence of protein markers in human serum and plasma that indicate the presence of traumatic brain injury.

Program/Equipment: Human Serum/Plasma Testing

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Signature Date:

(2) Competitive status – N/ A

(3) Authority previously cited if less than full and open competition was used on the previous acquisition – N/A

(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 – N/A

(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. N/A

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

W.DEYAMPERT.111 PRESCOTT.ANDREW.DEYAMPE 22 August 2024

RT.1112515646

2515646 Date: 2024.08.22 15:02:40 -05'00'

Typed Name Title: NCOIC Immunology

Requirements Certification:

I certify that the supporting data under my cognizance, which are included in the justification are accurate and

ZEIDAN.AMINA. Digitally signed by

ZEIDAN.AMINA.RAL.1108297936

RAL.1108297936 Date: 2024.08.22 14:58:38 -05'00' Date:

t

22 August 2024

Program/Equipment: Human Serum/Plasma Testing

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CPT Amina R. Zeidan

Typed Name:

Title: OIC Immunology

Program/Equipment: Human Serum/Plasma Testing

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23 August 2024

12. Fair and Reasonable Cost Determination:

I hereby determine that the anticipated cost to the Government for this contract action will be fair and reasonable based on price analysis techniques. As a part of the basis, certified cost and pricing data is not required per FAR 15.403-1(b)(3).

Signature:

d by

PAULOUSKAYA.SALAMEYA.1246035373

AMEYA.1246035373 Date: 2024.08.23 08:03:12 -05'00' Date: 23 August 2024

Typed Name Title: Contracting Officer

Contracting Officer Certification:

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

Typed Name: Title : Contracting Officer