JA_under-SAT_ Methotrexate reagents - 8312023 - Signed -Redacted.pdf

CUI//SP-SSEL

Control Number: 23-RHCO-C-552

CUI//CP-PROCURE

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

Memorandum for Record – Limiting Competition at or below the Simplified

Acquisition Threshold

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.

2. Description of Action: The Government’s requirement is to obtain Methotrexate reagents and consumables on a cost-per-kit via a firm fixed price contract for the Department of Pathology and Area Laboratory Services, Brooke Army Medical Center (BAMC). Under a cost-per-kit arrangement, the using laboratory pays for the use of the consumables, and services through the purchase of tests (i.e., reagents) compatible with the laboratory’s existing Roche chemistry analyzers. The Government projects award before 30 September 2023, with performance to start 1 October 2023;

award will be subject to the availability of Defense Health Program, (DHP) FY24 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(s) and Address:

Ark Diagnostics, Inc 48089 Fremont Blvd Fremont, CA 94538-6541

Brand Name Buy: Yes

3. Description of Services or Supplies: This requirement is a follow-on to the current contract of W81K00-18-P-0612 with ARK Diagnostics, expiring 30 September 2023.

This contract will ensure essential therapeutic drug monitoring for the Military Health system and BAMC Hematology/Oncology service management of patients on immunosuppressive therapy, for the Department of Pathology & Area Laboratory Services (DPALS) Reference Laboratory at the Brooke Army Medical Center (BAMC), Fort Sam Houston TX.

Delivery Period: 1 October 2023 to 30 September 2028

Amount: $218,808.75 (Base + Four (4) Option years) Base Period (1 October 2023 – 30 September 2024):

Option 1 (1 October 2024 – 30 September 2025):

Option 2 (1 October 2025 – 30 September 2026):

Option 3 (1 October 2026 – 30 September 2027): $ Option 4 (1 October 2027 – 30 September 2028):

$43,761.75 $43,761.75 $43,761.75 43,761.75

$43,761.75

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

Mandatory Tests/Functions and Estimated Volumes

Test Base Option 1 Option 2 Option 3 Option 4

Methotrexate Assay Kit

Methotrexate Calibrator kit

Methotrexate Control Kit (L, M, H)

Methotrexate Control Kit (5, 50, 500)

Methotrexate Dilution Buffer kit

15 15 15 15 15

4. Authority: FAR 13.106-1(b)(1): For purchases not exceeding the simplified acquisition threshold (SAT), only one source reasonably available, urgency, exclusive licensing agreements, brand name, or industrial mobilization.

5. Reasons for Authority Cited: The reagents must be fully compatible with the laboratories existing Roche chemistry instrumentation to ensure it is fully automated discrete random-access capabilities. This compatibility ensures ability to store regents at Federal Drug Administration (FDA) storage levels; capability of barcode identification; ability to print patient results as one per page; ability to interface with MHS-Genesis and be Risk Management Framework (RMF) and Health Insurance Portability and Accountability Act (HIPAA) compliant. Only 1 vendor is partnered with Roche to provide Methotrexate reagents for the existing equipment in BAMC DPALS.

Only ARK Diagnostics, Inc can provide the needed reagents and compatible with the existing fully automated chemistry equipment in a cost per test arrangement of estimated BAMC volume to perform the required testing mentioned above. Clinicians rely on these results to ensure timely medication changes to prevent toxic exposure to medication. Failure to provide testing would delay diagnosis and timely treatment.

6. Publicizing Contract Actions: For FAR Part 13 actions, the public display and synopsis requirements of FAR 5.201 and FAR 5.203 apply and will be followed. The Contracting Officer shall publish the notices required by FAR 5.201. A Sources Sought Notice was posted on 15 December 2022; upon finalization of 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 as required.

7. Market Research: A Sources Sought Notice was posted on Sam.Gov on 06

December 2022 with a response due date of 21 December 2022 in order to find companies (small and large) that could provide reagents for methotrexate testing as listed on the notice issued by the Government. There were no responses from any vendors. 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, to include a review of the College of American Pathologists’ website as well as the General Service Administration (GSA) schedule for Methotrexate reagents. This Market Research was conducted from March to July 2023. To date, historical and current market search has confirmed that only 1 vendor has the FDA approved methotrexate reagents that is compatible with the laboratory’s existing fully automated equipment. Based on the previous procurement efforts, there is only one vendor which is partnered to provide reagents compatible with existing laboratory equipment deemed technically acceptable. Only ARK Diagnostics, Inc. produces an open channel reagent partnered to be fully compatible with DPALS existing automated chemistry platform. Due to the limited number of compatible reagents for laboratory’s instruments, no further efforts will be made to obtain competition at this time.

8. Other Facts:

a. Procurement history.

(1) Contract W81K00-18-P-0612 was issued with a base period 01 October 2018 -

30 September 2019, plus Four (4) twelve-month option periods through 30 September 2023. This action was solicited on a full and open basis and yielded only one offeror.

9. Technical/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.

Typed Name: SFC Nydia R. Wickenden Date: 31 August 2023 Title: NCOIC DPALS

WICKENDEN.NYDIA Digitally signed by

Signature: WICKENDEN.NYDIA.REYES.12760 69647 Date: 2023.08.31 08:21:54 -05'00'

10. Contracting Officer Certification/Approval:

.REYES.1276069647

CARROLL.CICELY.D.1381612640

I hereby determine that the anticipated cost or price to the Government for this contract action will be fair and reasonable based upon based on price analysis techniques. As a part of the basis, certified cost and pricing data is not required per FAR 13.106-1(b).

I certify that this justification is accurate and complete to the best of my knowledge and belief, and that completing this purchase as a sole source is in the best interest of the Government. Additionally, I approve this justification to limit competition subject to the availability of funds and provided that the services or supplies herein described have otherwise been authorized for acquisition.

Typed Name:

Date:

Title: Contracting Officer

SIMMONS- Digitally signed by SIMMONS-

Signature: CARROLL.CICELY.D.1381612640 Date: 2023.08.31 08:55:45 -05'00'

Cicely D. Simmons-Carroll