P03 LSJ Bitscopic SM 092126.pdf

SOLE SOURCE JUSTIFICATION

GSAM/R 538.7104-3(b)

This justification aligns with the deviation outlined in the Revolutionary FAR Overhaul (RFO) for Part 8.4 - Ordering under the Federal Supply Schedule and GSAM/R 538.71, as required by Executive Order (E.O.)

14275, Restoring Common Sense to Federal Procurement, signed April 15, 2025. Deviation effective date: November 3, 2025.

Acquisition Plan Action ID: 36C248-27-AP-0414

1. Contracting Activity: Department of Veterans Affairs, NCO 8. Orlando VA Medical Center – 13800

Veterans Way, Orlando FL 32827.

Purchase Request: 675-27-1-2223-0001

2. Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501). Orlando VA Medical Center (OVAMC) is one of 10 sites that holds a license for utilizing the service/server; our sequence analysis and reporting of covid variant strains from sequenced covid specimens are processed with PreadiGene. The purpose of this new contract is for procurement of the PraediGene Precision Oncology module for informatics. This will allow analysis and reporting capabilities for sequenced oncology specimens with no lag time for implementation as the infrastructure is already in place by leveraging current informatic processes with use of the PreadiGene servers.

3. Order against: FSS Contract Number: GS-35F-362CA

Name of Proposed Contractor: Bitscopic, Inc

Street Address: 715 Colorado Ave STE B

City, State, Zip: Palo Alto, CA 94303

Phone: (206) 201-1863

4. Description of Supplies or Services:

The estimated value of the proposed action is $474,999.02 The service contract for oncology informatics includes interpretation and reporting for next generation sequencing results from solid tumor and heme/myeloid specimen testing. The informatics and variant interpretation service includes classification of identified genetic variants discovered in patient specimens selected for next generation sequencing. The variant classifications will provide the level of pathogenicity and all results are compiled within a clinical report that will be provided to ordering clinicians. Within the clinical report of the genetic variants, treatment recommendations that include FDA approved therapies as well as suitable clinical trials associated with classified variants in patient tumor type will be included.

Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor’s unique qualifications to provide the required supply or service.

GSAM/R 538.7104-3(b)(1)(ii): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized:

http://uscode.house.gov/browse.xhtml;jsessionid=114A3287C7B3359E597506A31FC855B3 https://www.gpo.gov/fdsys/pkg/USCODE-2011-title40/pdf/USCODE-2011-title40-subtitleI-chap5-subchapI-sec501.pdf

Only one responsible source, BitScopic Inc, can provide the oncology informatics service outlined in the description of service due to three major factors third parties must follow for handling VA owned data. Factor one includes having and authority to operate (ATO) which provides security and risk oversight reports known as controls that are continually evaluated and reported to the office of information and technology to maintain compliance with security standards. Factor two includes having an on-prem solution, so vendor hosted cloud computing is not required. If vendor hosted cloud computing is required, FedRAMP authorization is required and is multi-million-dollar investment for both the government and third party and requires several years to implement. Factor three includes having the system integrated with VistA so the report can be submitted directly to the patient’s chart. Bitscopic holds an ATO, has an on-prem solution and already has their system fully integrated with VistA. Therefore, this highly specialized system offers the VA a source for the oncology informatics service that saves the government a substantial amount of time and money that would otherwise be applied to a different source before the service could be attainable.

5. Describe Why You Believe the Order Represents the Best Value consistent with GSAM/R 538.7102-

2(4) to aid the contracting officer in making this best value determination: The combination of regulatory compliance, unique vendor qualifications, immediate operational readiness, clinical impact, and cost avoidance demonstrates that this order represents the best value for the government. It ensures timely, secure, and effective delivery of oncology informatics services, supporting the VA’s mission and patient care objectives.

6. Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted: Market research was conducted in accordance with FAR Part 10 and Veterans First requirements. The research included GSA Advantage, internet searches, and outreach to other VHA sites. While several sources were identified, only Bitscopic, Inc.

demonstrated the ability to meet VA data handling, integration, and security standards necessary to protect Veterans’ information and deliver the required oncology informatics service. No other sources were able to comply with these standards, ensuring the acquisition prioritizes Veterans’ needs and safeguards their data.

7. Any Other Facts Supporting the Justification: Procurement of the PraediGene Precision Oncology module for informatics requires having an existing PraediGene license; the government has already made a substantial investment of 1.6 million for distributing 10 PreadiGene licenses across 10 VA sites for use of this highly specialized system. Orlando VAMC is one of 10 sites that holds a current PreadiGene license and is able to purchase additional informatics modules that BitScopic currently offers though the GSA schedule with contract number GS-35F-362CA.

8. A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

PierianDx is actively working with the Digital Transformation Center (DTC) in the Office of Information and Technology to gain FedRAMP authorization for their system to gain Software as a Service (SaaS) approval. If FedRAMP authorization is granted and the service becomes SaaS approved by DTC, competition will be possible in the future.

9. 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. I understand that processing of this sole source justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by GSAM/R 538.71 as directed by RFO 8.4.

Amber Ginn Date Director of Molecular Diagnostics Orlando VA Medical Center

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

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

Stephen Mancuso Contracting Officer, NCO-8

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

Kurt Kramer Senior Contract Specialist, NCO-8 https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx https://dvagov.sharepoint.com/sites/VHAProcurement/VHAPM2/VHAPM_Part_806.3.aspx