JA PraediGene Redacted.pdf

PraediGene Bronze Edition (Annual License)

LIMITED SOURCES JUSTIFICATION

1. Contracting Activity: Department of Veterans Affairs (VA) Office of Procurement, Acquisition, and Logistics Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07731

2. Description of Action: The proposed action is for the award of a firm-fixed price Task Order under the General Services Administration (GSA) Multiple Award Schedule (MAS) Federal Supply Schedule (FSS) GS-35F-362CA with Bitscopic, Inc. for the renewal of one PraediGene software subscription, inclusive of maintenance.

3. Description of the Supplies or Services: VA Veterans Health Association Public Health Reference Laboratory (PHRL) has a requirement for the renewal of one PraediGene Bronze Limited software subscription, inclusive of maintenance. The PHRL has been providing clinical laboratory testing for Veterans since 2014, and public health investigation laboratory services since 2009. PHRL, a Veterans Health Administration (VHA) national laboratory, is located at the VA Palo Alto Health Care System and is a high-complexity, Clinical Laboratory Improvement Amendments (CLIA)-licensed laboratory offering validated assays for clinical care and public health investigations.

PHRL participates in College of American Pathologists (CAP) proficiency testing and is accredited by CAP. PHRL also participates in proficiency testing through the Centers for Disease Control and Prevention (CDC) (e.g., influenza, dengue or norovirus testing) and is aligned with the CDC-sponsored Laboratory Response Network (LRN) that supports the nation’s public health efforts. PHRL serves as the VA’s primary reference microbiology laboratory to: test for and aid in the diagnosis of unusual pathogens;

confirm atypical laboratory test results; test epidemiologically significant specimens with potential public health implications; and test for infectious diseases of public health consequence that are too rare or unusual for other laboratories to maintain testing capacity.

PraediGene is a laboratory workflow tool designed to allow users at three of the VHA referral laboratory sites (West Haven, Iowa City, Palo Alto) to electronically enter and track various medical lab tests for VA systemwide customers. In addition to these core capabilities, PraediGene contains advanced computational biology features and interfaces with Veterans Information Systems and Technology Architecture (VistA) Electronic Health Record (EHR) and Computerized Patient Record System (CPRS) systems. Once entered, work items are immediately available to all users for tracking, Deoxyribonucleic acid (DNA) analysis (when applicable), report generation, and generic workflow activities. PraediGene has the ability to associate and retrieve patient information directly from EHR systems. The DNA analysis features automatically predict and report resistance mutations given the organism’s genetic sequence. To ease reporting and transcription requirements, PraediGene is also able to generate “EHR friendly” input. This software will support the complete range of functions required by the PHRL, which includes: Automate PHRL workflow tasks and enable staff to electronically enter and track all medical lab tests, including Protected Health Information (PHI) and Personally Identifiable Information (PII); for example, support

DNA sequencing analysis used by PHRL for Human Immunodeficiency Virus (HIV) and Hepatitis C Virus (HCV) clinical tests, and automatically predict and report resistance mutations given an organism’s genetic sequence (this is also done for a number of other clinical tests); Integrate with the VA’s VistA EHR and CPRS systems and will retrieve patient information directly from VistA and produce Vista-compatible test results; Fully integrate DNA Quality Control (QC) checks and maintain all laboratory records to support CLIA and CAP licensing and audits; and automate all laboratory reports, financial reports, and management reports.

The Contractor shall provide software support in accordance with its GSA Schedule contract for the PraediGene software which includes publishing of bug/defect fixes via patches and updates/upgrades in function and technology to maintain the operability and usability of the software product. The period of performance shall from June 19, 2021 through June 18, 2022 with two 12-month option periods.

4. Statutory Authority: This acquisition is conducted under the authority of the Multiple- Award Schedule Program. The specific authority providing for a limited source award is Federal Acquisition Regulation (FAR) Part 8.405-6(a)(1)(i)(B), “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.”

5. Rationale Supporting Use of Authority Cited Above: The proposed source for this action is Bitscopic, Inc. 585 Broadway Street, Redwood City, CA. Based on market research, as described in Section 8 of this justification, it was determined that only the PraediGene Bronze Edition software subscription will meet the Government’s requirements. Only the PraediGene Bronze Edition software subscription can provide the following critical requirements: (a) automates laboratory workflow tasks used by PHRL, (b) enables electronic entry and tracking of all medical lab tests, including secure protection of PHI and PII, (c) delivers full support of DNA sequencing analysis used by PHRL for example HIV and HCV Resistance tests, (d) automatically predicts and reports resistance mutations to different drugs given an organism’s genetic sequence,

(e) interfaces with the VA’s VistA EHR and CPRS systems and can retrieve patient information directly from VistA can produce results in a format that is Vista-compatible,

(f) delivers fully integrated DNA QC checks to assess potential specimen mix-ups and verify repeat sequences obtained from patients tested multiple times, and maintains these laboratory records to support CLIA and CAP licensing and audits, and (g) supports automated laboratory reports, financial reports, and management reports.

These functions are critical to PHRL in order to guarantee thorough, efficacious specialized testing for veteran clinical care and based on the Government’s market research can only be provided by the required PraediGene Bronze Edition license.

PraediGene Bronze Edition is a proprietary software product; therefore, no other company has rights to access the proprietary code base necessary to maintain the PraediGene Bronze Edition for VA including software upgrades, updates, enhancements, and corrections. Access to this code is also needed to ensure all services provided are properly configured. Bitscopic, Inc. owns the proprietary intellectual rights to the PraediGene Bronze Edition software and is the only source capable of providing the necessary maintenance support.

If PraediGene Bronze is not purchased, PHSR's ability to effectively perform Public Health Reference laboratory work would be seriously diminished. Test results for Reference Lab samples from VA physicians would be at best outsourced to expensive commercial laboratories, or at worst delayed or not processed. Without this workflow tool, VA would not be able to successfully operate the PHRL leading to a significant increase in costs required to conduct nationwide testing using external outsourced laboratories like Quest or Labcorp, currently avoided by PHRL’s use of the PraediGene application. The cost of this additional support would be higher than the estimate cost of the required tool resulting in an average savings of $4,000,000.00 per year.

Moreover, manual processes would need to be used, resulting in significantly increased VHA labor costs, and the potential for errors would increase, thus affecting Veteran patient care. Further, non-searchable scanned laboratory data would not be seamlessly integrated with VistA as is currently provided by the PraediGene solution.

6. Efforts to Obtain Competition: Market research was conducted, details of which are in the market research section of this document. This effort did not yield any additional sources that can meet the Government’s requirements. It was determined that Bitscopic, Inc. is the only provider of PraediGene Bronze software subscription and associated maintenance. There is no competition anticipated for this acquisition. In accordance with FAR 5.301 and 8.405-6(a)(2) the award notice for this action will be synopsized on the Federal Business Opportunities website and this justification will be made publicly available within 14 days of award.

7. Actions to Increase Competition: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that would enable future actions to be competed.

8. Market Research: VA technical experts have been conducting on-going market research since April 2015 through present, and have reconfirmed all findings as of March 2021. VA technical experts reviewed other similar software products such as DNAStar, Geneious, and Sequencher and determined that only PraediGene can meet all of the Government functional and compatibility requirements discussed in Section 5 above. Furthermore, direct communications with Bitscopic in March 2021 confirmed Bitscopic has no authorized resellers for the PraediGene Bronze Limited software subscription. The confirmation email has been placed in the contract file.

9. Other Facts: N/A

10. Technical and Requirements Certification: I certify that the supporting data under my cognizance, which are included in this justification, are accurate and complete to the best of my knowledge and belief.

Mark Holodniy, M.D. Date: ________________________________

Director Signature: ____________________________ Public Health Surveillance and Research

11. Determination of Best Value: I hereby determine that the proposed contract action will represent the best value to the Government consistent with FAR 8.404(d). GSA has already determined that the prices on the FSS contract are fair and reasonable. Further price analysis will be conducted by comparing the quote with the Independent Government Cost Estimate. Additionally, price discounts will be sought.

Joshua Cohen Date: ________________________________

Procuring Contracting Officer Signature: ____________________________

12. Procuring Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief.

Joshua Cohen Date: ________________________________

Procuring Contracting Officer Signature: ____________________________

Approval

In my role as procuring activity Advocate for Competition, based on the foregoing justification, I hereby approve the acquisition of one (1) PraediGene Bronze Edition, including maintenance, on an other than fair opportunity basis pursuant to the authority cited in paragraph 4 above, subject to availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.

Date: ____________ Signature: __________________________________ Philip Weckesser Advocate for Competition Technology Acquisition Center

Office of Procurement Acquisition and Logistics