36C261-26-AP-2011-FY26-1713 JOFOC NCO21 Oncology Lab Tests - HCA Approved.pdf

Attachment 1: Request for Sole Source Justification Format >SAT

VHAPG Part 806.3 OFOC Page 1 of 6 Revision: 04 Effective Date: 12/15/25 Acquisition ID#: 36C261-26-AP-2011

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) For

Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C261-26-AP-2011 JOFOC Tracker: FY26 - NCO 21 - 686

1. Contracting Activity:

Department of Veterans Affairs (VA), Network Contracting Office (NCO) 21;

Veterans Integrated Services Network (VISN) 21, VA Central California Healthcare System (VACCHCS); 2815 E Clinton Ave, Fresno, CA 93703

PR#: 570-26-3-223-0075

2. Nature and/or Description of the Action Being Approved:

This procurement is for a Firm Fixed Price contract in accordance with RFO 12.102 Restricting Competition for the Acquisition of Commercial Products and Commercial Services, where acquisitions conducted are exempt from the requirements of RFO Part 6, but still requires a justification using the format of RFO 6.104-1.

VACCHCS proposes to enter a new contract on the basis of other than Full and Open Competition with NeoGenomics Laboratories, Inc. The address for the vendor is 9490 NeoGenomics Way, Fort Myers, Fl 33912. This procurement is to provide laboratory services to include packaging, pick up, and transport of specimens for NeoTYPE cancer profiles to its laboratories.

3. Description of Supplies/Services Required to Meet the Agency’s Needs:

The requested service will consists of as-needed oncology and molecular laboratory testing for Veterans with the VACCHCS catchment area. The requested lab tests that are required by VA oncology physicians and pathology department, including (but not limited to):

a. Neo Comprehensive – Myeloid Disorders: A 164-gene test that analyzes both DNA and RNA changes in blood cancers, with a single integrated medical report.

b. NEO RAS/RAF Panel Tissue: A 500+ gene comprehensive cancer profiling test that evaluates solid tumors using combined DNA and RNA analysis and includes advanced biomarkers used to guide cancer therapy.

c. NeoTYPE disease-specific profiles: Testing panels that combine multiple technologies (NGS, FISH, and other methods) into one consolidated diagnostic report.

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Acquisition ID#: 36C261-26-AP-2011

i. NeoTYPE cancer profiles, including comprehensive next generation (NGS) panels for solid tumors and hematologic malignancies.

ii. FISH assays for Solid Tumor & Heme including Global and Tech- Only services iii.300 or more immunochemistry (IHC) antibodies and stains

iv. Molecular diagnostic tests including but not limited to

a. Single gene assays

b. Targeted and comprehensive profiling panels

c. 28 10-color Flow Cytometry tests

v. Cytogenetics with industry-leading TAT

vi. Liquid Biopsy molecular testing when tissue specimens are not available or unavailable.

This procurement will consist of an Indefinite Delivery/ Indefinite Quantity (IDIQ) that will be inclusive of five (5) ordering periods. The services will be performed from 4/26/2026 through 4/25/2031.

Ordering Period 1: April 26, 2026 – April 25, 2027 Ordering Period 2: April 26, 2027 – April 25, 2028 Ordering Period 3: April 26, 2028 – April 25, 2029 Ordering Period 4: April 26, 2029 – April 25, 2030 Ordering Period 5: April 26, 2030 – April 25, 2031

The estimated value of proposed action is as follows:

Ordering Period 1: $700,000.00 Ordering Period 2: $700,000.00 Ordering Period 3: $700,000.00 Ordering Period 4: $700,000.00 Ordering Period 5: $700,000.00

Estimated Contract Total: $3,500,000.00.

Overall IDIQ Ceiling: $5,000,000.00.

The Government will include the option to extend the effective period of performance utilizing RFO 52.217-8, Option to Extend Services under this contract for a period not to exceed six (6) months.

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4. Statutory Authority Permitting Other than Full and Open Competition:

(X) (1) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements per 41 USC §3304(a)(1) as implemented by

RFO 6.103-1;

( ) (2) Unusual and Compelling Urgency per 41 USC §3304(a)(2) as implemented by RFO 6.103-2;

( ) (3) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services per 41 USC §3304(a)(3) as implemented by RFO 6.103-3;

( ) (4) International Agreement per 41 USC §3304(a)(4) as implemented by RFO 6.103-4

( ) (5) Authorized or Required by Statute per 41 USC §3304(a)(5) as implemented by RFO 6.103-5;

( ) (6) National Security per 41 USC §3304(a)(6) as implemented by RFO 6.103-6;

( ) (7) Public Interest per 41 USC §3304(a)(7) as implemented by RFO 6.103-7;

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

The procurement is a sole source acquisition to NeoGenomics. There are no other sources of this service that will satisfy agency requirements. Neogenomics is the only vendor that can provide NeoGenomics developed assays, with the same gene content, testing method, and validated reporting structure. Alternative testing would change clinical results and disrupt established patient care practices. NeoGenomics simplifies the ordering process with expertly designed single-order products, such-as NeoTYPE cancer profiles.

Using a different lab that does not utilize the NeoTYPE cancer profile would result in different test methods, deeming the results non-comparable. Replicating this profile at another laboratory would require ordering multiple separate assays, often across different specialty labs, resulting in multiple accessions and separate reports. This would increase turnaround time, administrative burdens, and the risk of fragmented or incomplete diagnostic workups. It would also increase overall costs, as bundled pricing would be lost and individual component testing is typically billed separately

In some cases, it could require establishing or modifying multiple reference laboratory contracts to cover the full scope of testing currently contained within a single NeoTYPE profile. These panels are disease specific, internally developed, and validated by NeoGenomics. They integrate cytogenetics, FISH, molecular testing, and pathology interpretation into a single consolidated report under one accession. Other reference laboratories may offer similar individual methodologies, but they do not provide the same proprietary NeoTYPE configuration with unified reporting and built in reflex algorithms.

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Acquisition ID#: 36C261-26-AP-2011

This would cause a disruption to Veteran care as alternative testing would change clinical tests and would require additional testing for the Veterans therefore delaying Veteran treatment.

The lab is located in Southern California and all cases are delivered via local courier which allows for a timely turnaround to receive the results.

NeoGenomics has been providing these services to VACCHCS satisfactorily.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as possible (including whether a notice was or will be publicized as required by RFO Part 5 and, if not, which exception under RFO Part 5 applies):

A Notice of Intent (NOI) to sole source was posted to SAM.GOV from 02/02/2026 to 02/09/2026 under number 36C26126Q0374. Utilizing the Notice of Intent to Sole Source, one (1) response was provided. CorePath Laboratories provided a capability statement for their services that can be provided. They also stated that Neotype is exclusive to NeoGenomics, but they could provide competitive services.

7. Determination by the CO that the Anticipated Cost to the Government will be

Fair and Reasonable:

To ensure the final contract price is fair and reasonable, a determination will be made in accordance with RFO 12.201-1. The Contracting Officer will determine the price as fair and reasonable by comparing the Independent Government Estimate and quoted priced on previous neo lab testing purchases as a competitive quote will not be available.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

Extensive market research was conducted utilizing North American Industry Classification System (NAICS) code 541380, Testing Laboratories and Services and keyword “NeoTYPE” in SAM.gov as well as the Small Business Administration (SBA) Dynamic Small Business Search. The purpose of these searches was to seek contractors that are able to provide laboratory testing utilizing the NeoTYPE profile at fair and reasonable prices. The search was also to determine if there are contractors who obtained limited agreements with NeoGenomics to provide laboratory testing using the NeoTYPE profile.

As described in Section 6 above, market research, in accordance with RFO Part 10, was conducted by synopsis of the proposed acquisition, advising industry of the pending acquisition, and soliciting inquiries from interested parties. Through market research, the CO has determined that NeoGenomics does not have any authorized third party service providers for laboratory testing for the NeoTYPE profile tests that are listed in Section 3. Utilizing SAM.gov and the keywords, NeoTYPE, the results determined contracts for NeoTYPE profile testing services were only awarded to NeoGenomics. The SBA Small Business Dynamic Search database was searched https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-5 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-5 https://www.acquisition.gov/far-overhaul/far-part-deviation-guide/far-overhaul-part-5

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Acquisition ID#: 36C261-26-AP-2011 using NAICS 541380 and keyword, NeoTYPE. The search resulted in zero (0) Small Disabled Veteran Own Small Business/Veteran Own Small Business (SDVOSB/VOSB) vendors.

The NOI result garnered one (1) response from CorePath Laboratories. While they do provide lab testing consistent with the needs of VACCHCS, the lab would have to replicate the profile which would require ordering multiple separate assays, often across different specialty labs, resulting in multiple accessions and separate reports.

This would increase costs and delay Veteran care while waiting for results. The lab is also located in San Antonio, Tx which would delay the timely turnaround to receive test results.

Due to the proprietary nature of this requirement, it must be awarded on a sole source basis to NeoGenomics.

9. Any Other Facts Supporting the o Use of Other than Full and Open Competition:

There are no other supporting facts.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

NeoGenomics Laboratories, LLC CorePath Laboratories

11. A Statement of the Actions, if any, the Agency May Take to Remove or

Overcome any Barriers to Competition before Making subsequent acquisitions for the supplies or services required:

NeoGenomics is the only source that can provide the NeoTYPE cancer profiles in conjunction with the lab tests listed above in Section 3 due to the proprietary nature of the service. NeoGenomics does not authorize any third party service providers to provide the requested services. The Department of Veterans Affairs will continue to monitor the commercial marketplace to determine if other sources are responsible and capable of providing this type of service that meets the needs of VISN 21.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and 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.

Crystal English Interim Laboratory Manager

VACCHCS

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13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Cynthia Diezel Contracting Officer Network Contracting Officer 21

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $900K): I certify the justification meets requirements for other than full and open competition.

Nicholas Kluch Network Contracting Office 21 Director of Contracting

c. VHA RPO HCA Review and Approval: I have reviewed the foregoing justification and find it to be complete and accurate to the best of my knowledge and belief and recommend approval (if over $90 million) or approve ($900K to $90 million) for other than full and open competition.

Curtis M. Jordan Executive Director, Regional Procurement Office West Head of Contracting Activity (HCA) https://dvagov.sharepoint.com/sites/vhapromanual/SitePages/VHAPM-Part-806.3.aspx