W81K00-26-Q-A005 JA Sole Source_legal_COR ko signed_CAFCsigned Histology_Redacted.pdf

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: Reagents, equipment, and services for high throughput specimen processing services including Immunohistochemistry (HCO) staining, In-situ Hybridization (ISH) staining, Immuno-Fluorescence staining, Special Staining, Whole slide scanning, Image management and Anatomic Pathology Lab workflow, integration, and connectivity solutions for Brooke Army Medical Center (BAMC) Department of Pathology and Area Laboratory Services Histology Laboratory (DPALS), Fort Sam Houston, Texas.

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:

Prepared by:

Contracting Officer:

Technical Representative:

Date:

Requirements Representative:

CUI//SP-SSEL

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

2 JUN 2023

Reviews

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

3 JUN 2023

Sole Source Justification and Approval Under FAR 13.501

1. Contracting Activity: Medical Readiness Contracting Office-West

2. Description of Action: The Brooke Army Medical Center – Department of Pathology and Area Laboratory Services (DPALS) request the purchase of cost-per-test agreement via a recompete of a firm fixed contract to include reagents instrument/equipment, consumables, controls, and any necessary services (e.g., maintenance of furnished equipment) to conduct high throughput specimen processing including Immunohistochemistry (IHC) staining, In-Situ Hybridization (ISH) staining, Immuno-Fluorescence staining, Special Staining, Whole Slide Scanning, Image Management, and Anatomic Pathology Lab workflow, integration, and connectivity solutions for the DPALS at Brooke Army Medical Center (BAMC). 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).

Proposed Contractor:

3. Description of Supplies/Services: The Government’s requirement is to obtain a fully automated sample preparation and consultation system for BAMC DPALS Histology Laboratory, Fort Sam Houston, Texas. The Histology fully automated sample preparation and consultation system shall provide high throughput processing services including the following:

• Immunohistochemistry (IHC) staining

• In-situ Hybridization (ISH) staining

• Immuno-Fluorescence staining

• Special Staining

• Whole slide scanning

• Image management

• Anatomic Pathology Lab workflow, integration, and connectivity solution

• Routine Staining (i.e. H&E)

• Automated glass coverslipping

To be able to conduct these tests, reagents and automated analyzers are needed for time period of 1 October 2025 to 30 September 2026 with three (3) option years 1

4 JUN 2023

October 2026 thru 30 September 2028. The equipment must be able to connect to the MHS Genesis and must come with an un-interruptible power supply capable of providing power for at least 45 to 60 minutes. All in-vitro diagnostic equipment and supplies must be approved by the Food and Drug Administration (FDA).

Base Period (1 October 2025 – 30 September 2026):

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

Option 2 (1 October 2027 – 30 September 2028):

Option 3 (1 October 2028 – 30 September 2029):

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 of the simplified procedures for certain commercial items.

5. Reason for Authority Cited:

Roche is the only vendor which can satisfy all the requirements listed in para 3 to include specialized dual in-situ hybridization (ISH) assays required for critical diagnostic applications in oncology and hematopathology. received FDA approval for its

The assay is essential for determining gene amplification in breast and gastric cancers, a key factor in assessing eligibility for -targeted therapies. It provides precise data directly from tissue samples, and no equivalent test offers the same level of integration and validation for our existing diagnostic platform.

assay is critical for the accurate diagnosis of B-cell lymphomas and plasma cell neoplasms, enabling simultaneous visualization of kappa and lambda light chains on a single tissue slide. assay ensures standardized interpretation aligned with clinical diagnostic protocols.

submitted a sole source letter on 17 April 2025 confirming they are the sole source manufacturer for all Advanced Staining instrumentation, reagents and ancillaries, to include in- situ hybridization staining. In-situ hybridization staining is only available through this vendor as they have the patent and FDA approval, and no other vendor which offers this test type can meet all the above stated requirements.

Control Number:

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

5 JUN 2023

6. Efforts to Obtain Competition: A sources sought was posted on 23 January 2025 with questions due on 5 February 2025. Questions were received. Those questions and answers were posted on 18 February 2025 with capability statements due on 28 February 2025. Three (3) vendors responded:

Vendor Name Small or Large

Location Capability Assessment

7. Actions to Increase Competition: is the only U.S. FDA licensed vendor that can meet the requirement. The posted sources sought on SAM.GOV was the effort to obtain competition. Although two (2) other capabilities statements were received, is the only company that can complete the service right now.

Progress is occurring rapidly in the field. BAMC laboratory domain experts are continually looking ahead to the next major breakthroughs to advance medical testing capabilities. In the coming option years, BAMC domain experts will continue to conduct market research and solicit input from the broader laboratory community on new testing capabilities to offer DoD beneficiaries.

8. Market Research: The contract specialist began market research on 23 January 2025 with a sources sought notice posted on SAM.GOV with a response date of 28 February 2025 to find companies (small and large) that could provide reagents for Histology fullly automated sample preparation and consultation system as listed on the notice issued by the Government. There were no responses from small businesses.

Prior to the posting for the sources sought notices, market research was conducted by

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

6 JUN 2023

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; review of the College of American Pathologists’ website, review of the FDA approved methodologies listings, as well as the General Service Administration (GSA) schedule. The DPALS Market Research was conducted from 01 September 2023 to 29 March 2024.

9. Interested Sources: As required by FAR 5.201, a Sources Sought Notice was posted to https://sam.gov, the official GPE, on 23 January 2025 with a response due date of 28 February 2025 to find companies (small and other-than-small) that could provide an FDA approved in-situ hybridization staining. Three (3) companies, provided capabilities statements. After DPALS reviewed the capability statements from the sources sought notice, it was determined that is the only FDA approved company to provide in-situ hybridization staining testing.

10. Other Facts:

a. Procurement history.

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

W81K00-21-P-0269 was awarded to on 2 September 2021 with a base period from 01 October 2021 to 30 September 2022 plus four (4) twelve (12) month option periods from 1 October 2023 thru 30 September 2026.

W81K00-18-D-0001 was awarded to on 1 May 2018 with a base period from 01 October 2017 to 30 September 2018 plus one (1) ordering year of 1 October 2019 to 30 September 2020.

(2) Competitive status:

W81K00-21-P-0269, competitive acquisition W81K00-18-D-0001, a sole source acquisition

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

W81K00-18-D-0001 - 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

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

7 JUN 2023

circumstances causing this action to now limit the sources –This contract is being recommended for early re-competition due to a substantial and unforeseen change in scope that significantly alters the original requirements and objectives. The initial contract was limited to the acquisition of specific dual in-situ hybridization (ISH) assays from for

. However, recent changes in clinical protocols, diagnostic testing volumes, and expanded biomarker requirements have dramatically increased both the technical complexity and breadth of testing needed.

Key changes include:

(i) Expansion of Diagnostic Scope

New testing guidelines now require the inclusion of additional biomarkers and multiplex assays not covered under the original contract, necessitating broader assay capabilities and flexibility in technology solutions.

(ii) Increased Testing Volume and Throughput Needs

Patient testing volume has significantly increased due to service expansion and revised screening protocols, requiring reassessment of vendor capacity, reagent supply logistics, and instrument throughput.

(iii) Integration with New Clinical Systems

The diagnostic workflow must now be integrated with newly implemented laboratory information systems (LIS) and electronic health record (EHR) platforms, which may involve technical specifications not addressed in the existing contract.

(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. Proprietary Technology: The probe cocktails and detection systems used in these Dual ISH assays are proprietary to

, and no generic or third-party equivalents exist that provide identical performance, specificity, or regulatory assurance.

Clinical Continuity and Reduced Risk: Switching to a different vendor or method would introduce variability in test performance and interpretation, potentially impacting patient care and delaying treatment decisions. Maintaining continuity with minimizes diagnostic risk.

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

8 JUN 2023

Technical and Clinical Support: offers extensive technical training, on-site support, and pathologist education, which ensures efficient assay implementation, troubleshooting, and result interpretation.

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.

Date: see digital signature

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.

______________ __ Date: see digital signature

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 based on the independent Government Estimate.

_______ 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.

______ Date: see digital signature

Contracting Officer

9 JUN 2023

Approval

Based on the foregoing justification, I hereby approve the procurement of Reagents, equipment, and services for high throughput specimen processing services for and any necessary products to conduct testing in support of the Department of Pathology and Area Laboratory Services, for the estimated dollar value of on an other than full and open competition basis pursuant to the authority of State either 41 U.S.C. as implemented by FAR 13.501(a)(1)(ii), subject to availability of funds, and provided that the services and property herein described have otherwise been authorized for acquisition.