36C261-25-AP-0808-FY25-968 JOFOC NCO21 Praedico Software - HCA Approved - PRINT_Redacted.pdf

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REVISION: 01

Acquisition ID#: 36C261-25-AP-0808

DEPARTMENT OF VETERANS AFFAIRS

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C261-25-AP-0808 JOFOC Tracker 25: FY25-NCO 21-936

1. Contracting Activity: Department of Veterans Affairs (VA), Veterans Health Administration (VHA), Network Contracting Office (NCO) 21, on behalf of the Veterans Integrated Service Networks (VISN) 21, VA Palo Alto Healthcare System (VAPAHCS).

2237: 640-25-1-638-0010.

2. Nature and/or Description of the Action Being Processed: This procurement is for Praedico Immunization Analytics Module software 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.

The nature of this action is to request approval to procure the Praedico Immunization Analytics Module software as a sole source, open market action. This a new requirement that will be awarded under a firm-fixed-price contract. This procurement will be awarded to Bitscopic, Inc., a small business, located at 715 Colorado Ave., Ste B, Palo Alto, CA 94304.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: : The Public Health National Program Office (PHNPO) of VAPAHCS has a need for the Praedico Immunization Analytics Module software. The requirement is to provide the module software, which consists of a one-year base period with two (2) one-year option periods.

The period of performance and estimated costs are:

Contract Period Period of Performance Estimated Cost Base Year 05/1/2025-04/30/2026 $500,000.00 Option Year 1 05/1/2026-04/30/2027 $532,500.00 Option Year 2 05/1/2027-04/30/2028 $567,112.50 Total Cost: $1,599,612.50

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

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Acquisition ID#: 36C261-25-AP-0808

( ) 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 Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): PHNPO conducts public health surveillance and research within VA Palo Alto Healthcare System. PHNPO’s current responsibilities include:

Public Health Surveillance Promotion of Public Health Surveillance and Reporting by VHA Facilities Epidemiologic Investigations and Lookbacks Public Health Reference Laboratory Public Health Policy and Document Review Public Health Subject Matter Expertise and Scientific Research

This is a Non-IT procurement Item Number 41, Direct Medical Diagnostic or Treatment System (Purchased Commercial Off The Shelf [COTS] Software used for purposes of direct patient care), VA Directive 6008, Appendix A, November 2, 2017 Epidemiologic Investigations and Lookbacks.

Non-IT procurement Item Number 41, refers to a specific category within the VA's non-IT procurement system under VA Directive 6008, Appendix A.

A lookback is an organized process for identifying patients and/or staff with an exposure to potential risk incurred through past clinical activities, with the explicit intent to notify them and offer care and recourse, as appropriate. An epidemiologic investigation is a study of potentially-affected populations with the intent to ascertain a linkage between health effects (e.g., an infection) and a cause (e.g., an exposure). Public health epidemiologic and lookback investigations conducted in VHA are crucial in establishing safe practices to control preventable Veteran illness and maintain transparency and accountability. Maintaining a trained and experienced team of epidemiologists provides the necessary factual investigative work which allows VA to effectively field questions and provide necessary transparency while successfully caring for Veterans amidst the turmoil these types of investigations inevitably bring about.

Praedico Immunization Analytics Module is the primary tool of PHNPO for performing investigative, lookback, epidemiologic, and routine public health surveillance activities.

The PHNPO already is using three “Bitscopic” Tools and several modules that connect to these tools.

These are Praedico, PraediGene, and PraediVault. Bitscopic Inc. solutions seamlessly works with the VA electronic health record environment.

All Bitscopic Inc. products are already integrated with secure infrastructure provided by VA Office of Information Technology (OIT). For example, each of the products has been customized to use OIT’s secure access software composed of 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.

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Acquisition ID#: 36C261-25-AP-0808

Bitscopic Inc. products also are configured to use the VA’s secure internal networks for their internal communications with each other as well as network interfaces with VistA and other systems, such as VA’s Telehealth servers. Integrated with Bitscopic’s networking configurations are the use of large-capacity storage systems and data backup systems which must also meet VA security standards that are provisioned by OIT.

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 VA’s VAST data, common user help functions. 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.

There is no other source of supply/service that will satisfy agency requirements. The Praedico Immunization Analytics Module is only commercially available through the manufacturer Bitscopic, Inc., a small business. The module is a proprietary software that is created, maintained, and owned by Bitscopic Inc. There are no resellers of this software, nor any authorized third party to maintain/modify the Praedico Immunization Analytics Module software.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: Market research was conducted, details of which are in section 8 of this document. This effort did not yield any additional sources that could meet the Government's requirements. There is no competition anticipated for this acquisition. Additionally, the proposed intent to sole source was posted to contract opportunities (36C26125Q0269) on March 03, 2025, with a response due date of March 10, 2025. No responses were received.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and Reasonable: IAW FAR 13.106-3(a)(2), the anticipated cost to the Government will be considered fair and reasonable by comparing the proposed pricing to the independent government cost estimate (IGCE) and previous purchases.

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

Market Research Was Not Conducted:

Market research was conducted and due to the proprietary nature of this requirement no Service- Disabled Veteran Owned Small Businesses (SDVOSBs) or Veteran Owned Small Businesses (VOSBs) were found who can meet this requirement.

A query on SBA Small Business Dynamic Search Portal was conducted using two (2) searches.

Searched “513210” and keyword “Praedico” with zero (0) results. A query on SBA Small Business Dynamic Search Portal for Service-Disabled Veteran Owned Small Businesses (SDVOSBs) or Veteran Owned Small Businesses (VOSBs) found several VOSBs and SDVOSBs, but none meets the agency requirement.

VA Palo Alto Medical Center already is using “Bitscopic” tools and several modules that connect to the tools. Of more than 10-year use of these tools have increased the capacity to process samples and effectively surveil the entire VA system for several years. It would not be in the best interest of the government to change an already very effective and secure ecosystem with a product foreign to that ecosystem. It would not be practically efficacious for VA to change vendors as the existing tools and their available modules are extremely effective. There is no other source of supply/service that will satisfy agency requirements.

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Acquisition ID#: 36C261-25-AP-0808

A Federal Procurement Data Systems (FPDS) search found similar awards for different modules that are compatible with the requested Praedico Immunization Analytics Module provided by Bitscopic.

These awards were made by Network Contracting Office (NCO) 21 via Federal Supply Schedule (FSS) General Services Administration (GSA) and Open Market. The vendor was contacted to inquire if the requested module was on GSA and Bitscopic indicated this module is not available on FSS GSA contract and is considered open market.

The following procurements were awarded in the past by Network Contracting Office (NCO) 21 to Bitscopic Inc.:

36C26120F0458 $3,000,000.00 08/14/2020 36C26123P1266 $3,175,753.04 06/23/2023 36C26124P1385 $500,000.00 08/01/2024 36C26121P0602 $474,999.00 03/17/2021 36C26122P1255 $499,999.00 06/23/2022

A sources sought notice (36C26125Q0269) was posted on Contract Opportunities on SAM.GOV from January 31, 2025, to February 11, 2025. No response was received. The sources sought notice (36C26125Q0269) was also posted on GSA e-Buy and no response were received either.

The notice of intent to sole source was posted on Contract Opportunities on SAM.GOV from March 03, 2025 to March 10, 2025. No response were received.

Praedico Immunization Analytics Module software is commercially available through the manufacturer Bitscopic, Inc., a small business. There are no authorized distributors for this Biorepository Module and currently is not on a Schedule. This procurement must be through the Open Market.

The Non-Manufacturer Rule (NMR) does not apply to this requirement. Bitscopic, Inc., a small business, is the original equipment manufacturer (OEM) and sole authorized distributor of the Bitscopic Praedico Immunization Analytics Module.

The Buy American Statute or Trade Agreement Act does not apply because of applicability of FAR 25.401(a)(5) exception. FAR 25.401(a)(5) states, Other acquisitions not using full and open competition, if authorized by subpart 6.2 or 6.3, when the limitation of competition would preclude use of the procedures of this subpart; or sole source acquisitions justified in accordance with 13.501(a).

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: Bitscopic Inc has been providing Satisfactory performance on its past and current contracts with NCO 21.

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

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Acquisition ID#: 36C261-25-AP-0808 future acquisitions, appropriate market research will be conducted to determine if sources capable of meeting the agency’s needs have become available in the marketplace.

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.

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

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

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.

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 open competition.