NCO 21 - FY23 - 229 JOFOC - 36C261-23-AP-2565 Biorepository Software HCA APPROVED - FINAL_Redacted.pdf

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DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261-23-AP-2565 JOFOC Tracking Number: 2023-05-13T09:39:53

1. Contracting Activity: Department of Veterans Affairs, Veterans Health Administration, Regional

Procurement Office West, Network Contracting Office (NCO) 21, for the Veterans Integrated Service Network (VISN) 21, VA Palo Alto Health Care System (VAPAHCS), 3801 Miranda Avenue, Palo Alto, CA 94304.

2237: 640-23-2-486-0134

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

This procurement is for the Bitscopic Biorepositroy Module (BBM) [Bronze Edition] for the Public Health Reference Laboratory (PHRL) located at the VA Palo Alto campus in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

This procurement is a new requirement using a Firm-Fixed-Price, Sole Source, contract to Bitscopic, Inc., 715 Colorado Ave., Ste B, Palo Alto, CA 94304. There is no other source of supply/service that will satisfy agency requirements. The Bitscopic Biorepository Module is a proprietary system of Bitscopic, Inc. Bitscopic does not have any certified resellers for this module and is a Small Business under NAICS Code 513210 (previously was 511210), Software Publishers.

3. Description of Supplies/Services :

(VAPHB) is expected to house more than 800,000 COVID-19 samples. Therefore, VAPHB requires secure Biorepository Software to responsibilities and current workflow. The Bitscopic Biorepository Module (BBM) [Bronze Edition], is an operational biorepository management application that integrates clinical, specimen and genomic data collected for multiple biorepository purposes. BBM is an optional PraediGene License module that seamlessly aggregates honest broker with biorepository workflow/functionality, thus allowing for data integration while protecting patient privacy. PHRL currently has a PraediGene workflow license. By facilitating the automated de-identification of specimen and associated clinical and genomic data, BBM creates a future proofed specimen set that can withstand new workflows and be connected to new associated information over time.

PHRL currently has a contract for a Bitscopic Laboratory Workflow License called PraediGene. This request is for a module that attaches to the current license (Praedico24). PraediGene is a proprietary product.

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The Bitscopic Biorepository Module (Bitscopic, Inc.) is the only tool available that can be customized requires the ability to be modified or scaled for the VA, shall contain all the functionality needed by the VA, and/or use customizable statistical algorithms necessary to account for the unique VA data.

These are required capabilities of the system needed by the VA, they do not present viable alternatives. The Bitscopic Biorepository Module is a proprietary system of Bitscopic, Inc., no other company would be permitted to work on adaptation of this tool for the VA.

Period of Performance

1 Bitscopic Biorepository Module for VA Palo Alto Health Care System Palo Alto

06/23/2023 06/22/2024

2 Option 1, Option 2, Option 3, and Option 4 for items and locations 1 - 3

Option Year 1: 06/23/2024 06/22/2025 Option Year 2: 06/23/2025 06/22/2026 Option Year 3: 06/23/2026 06/22/2027 Option Year 4: 06/23/2027 06/22/2028

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

( X ) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency ( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert

Services ( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

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

tools and several modules that connect to the tools. Of more than 10-year use of these tools have increased their capacity to process samples and effectively surveil the entire VA system for several years.

The BBM will be part of an ecosystem of software and hardware already integrated together to operate seamlessly in supporting the daily operations of the Public Health National Program Office (PHNPO). The ecosystem includes a suite of Bitscopic technologies that are joined with each other and with the VA operating environment and infrastructure.

The ecosystem components include:

Servers and Secure Infrastructure: All Bitscopic Inc. products are already integrated with secure infrastructure provided by VA Office of Information Technology (OIT). For example, each of the

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Personal Identification Verification (PIV) cards and Single Sign ON Internal (SSOi) systems. These customizations occur throughout the ecosystem to secure the highly sensitive data used by PHNPO.

Additionally, all the products have been installed to run on OIT servers in order to meet VA security standards.

Integration with VA Networks and Storage Systems: Bitscopic Inc. products also are configured to network interfaces with VistA and other -capacity storage systems and data backup systems which must also meet VA security standards that are provisioned by OIT.

Sharing of Common Technology: Additionally, the current tools and applications use common proprietary software technology for performing tasks which are shared by all their products, such as data extraction and queries to VistA sites, common hospital site lookups using common user help functions, and so on. Software that is common to all the Bitscopic products in the ecosystem benefit from being consistent, easier to support and maintain, and cost effective to develop.

Ecosystem-level VA Approvals: The ecosystem also includes the communication capabilities used by the vendor to support all the operational components. Through a VA-authorized Interconnection Systems Agreement (ISA), their products are configured with the VA network to allow remote access for problem resolution, support, and maintenance. Further, the necessary Authority to Operated (ATO) issued by the VA authorizes the entire ecosystem and all its individual components.

Introduction of a foreign product would impact the existing ecosystem in several ways:

Any common tasks between Bitscopic Inc. products, such as one product communicating with another to make a VistA query, would need to be replaced, likely by building new interfaces or new queries. Until this functionality was developed, the ecosystem of products may lose critical functionality. To replace any lost functionality would require an unknown amount of schedule time, resources, and cost.

A new or foreign product would not be authorized under the current VA Authority to Operate (ATO).

The new product would need to apply for an ATO and go through the approval process. This would take several months at a minimum and consume an unknown amount of costs. During this period, parts of the ecosystem would not be functional and would impact PHNPO operations.

A foreign product may not immediately integrate with the current VA security standards that the rest of the current ecosystem does. Customization of the foreign system to be PIV-enabled and SSOi integrated would be needed. Configurations by OIT Networking Team to use the VA intranet and interface with VistA systems and secure storage systems would need to be approved and implemented. A new Interconnection Security Agreement (ISA) would be needed for remote vendor support, as the current authorization only applies to Bitscopic Inc. This would require an unknown amount of schedule time, resources, and cost.

The current ecosystem shares certain databases between them. A new product would not have access to this shared data and would likely need to develop one or integrate it with the existing suite of tools. This would require an unknown amount of time and cost.

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It would not be in the best interest of the Government to disturb an already effective and secure ecosystem with a product foreign to that ecosystem, nor for VA to change vendors as the existing tools and their available modules that are extremely effective. PHRL processes 12,000 COVID-19 clinic samples per month. Palo Alto Medical Center is expected to handle 800,000 in the biorepository. Failure to provide this tool, jeopardizes all stored samples and will be at risk for misidentification and/or contamination.

Accordingly, Bitscopic Inc. is the only firm capable of providing the supplies and services described in Section 3 above without the Veteran's Health Administration experiencing unacceptable delays in fulfilling its requirements.

There is no other source of supply/service that will satisfy agency requirements. The Biorepository Module is commercially available through the manufacturer Bitscopic, Inc., a small business for NAICS code 513210 (previously 511210). This software is proprietary, and Bitscopic Inc. has no authorized distributors for this Biorepository Module.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

A Notice of Intent to Sole Source was posted to Contracting Opportunities under 36C26123Q0603 from April 21, 2023 to May 08, 2023; yielding zero (0) responses from any interested and/or authorized vendors. This notice provided contractors the opportunity to submit a technical package, that provides clear and convincing evidence that they can meet the Government's requirement. To date, no one has responded.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable:

Fair and reasonable pricing will be determined based on a comparison of historical prices paid for recently awarded VA purchases in accordance with FAR 13.106-3(a)(2)(ii).

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted:

Several sources were utilized to conduct market research. They were: Internet, Federal Procurement Data Systems (FPDS), Electronic Contract Management System (eCMS), GSA Advantage/eLibrary, Vendor Information Pages (VIP), VetCert, System for Award Management (SAM), and National Aeronautics and Space Administration (NASA) Solution for Enterprise-Wide Procurement (SEWP).

a) A query on Vendor Information Portal (VIP) was conducted using two (2) searches. Searched

Searched

b) Market research efforts also include FPDS-NG, Contract Opportunities, VA NAC Catalog, GSA, Bitscopic Inc. by Network Contracting Office 21 (NCO 21) under 36C26121P0602 on March 17, 2021, for $474,999.00 using NAICS code 541511. Bitscopic Inc. is a Small Business for NAICS code 541511.

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A second award to Bitscopic Inc. by NCO 21 under 36C26122P1255 on 6/23/22 for $499,999.00. using NAICS code 541511. Bitscopic Inc. is a Small Business for NAICS code 541511.

These contracts were awarded under a Sole Source procurement.

c) The required supplies and services are not available through an FSS and/or SEWP contract. This was confirmed by searches on both GSA and SEWP. Also, the Contract Specialist contacted Bitscopic Inc. to ensure this request was not on their already existing GSA contract GS-35F-362CA.

d) The nonmanufacture rule (NMR) does not apply to this requirement. Bitscopic, Inc., the manufacturer and sole authorized distributor. They are a Small Business under NAICS code 513210.

e) A Notice of Intent to Sole Source was posted to Contracting Opportunities (SAM.gov) under 36C26123Q0603 from April 21, 2023, to May 08, 2023. This notice provided contractors the opportunity to submit a technical package, that provides clear and convincing evidence that they can meet the Government's requirement. The posting yielded zero (0) responses from any interested and/or authorized.

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

None

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

To date, no other sources have written to express an interest in this requirement; except Bitscopic Inc., a Small Business.

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:

In future acquisitions, appropriate market research will be conducted to determine if sources

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.

J Date Program Analyst Public Health National Program Office

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

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

Date Contracting Officer, Supply 1 Network Contracting Office (NCO 21)

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Date Director of Contracting

Network Contracting Office (NCO 21)

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 approve ($750K to $7.5 million (or $15.0 million for acquisitions described in FAR 13.500(c)) for other than full and

Executive Director, Regional Procurement Office West Date Head of Contracting Activity (HCA)

25 MAY 23