(S03) JA_Clinical Surveillance_redacted.pdf

Control Number TAC-20-51539

JUSTIFICATION FOR OTHER THAN FULL AND OPEN COMPETITION

1. Contracting Activity: Department of Veterans Affairs (VA) Office of Procurement, Acquisition, and Logistics

Technology Acquisition Center 23 Christopher Way Eatontown, NJ 07724

2. Description of Action: The proposed sole source action is for the award of a firm-fixed price (FFP) contract to Bitscopic Inc., 715 Colorado Ave Ste B, Palo Alto, CA, 94303-3907, for the purchase and implementation of brand name Bitscopic PraedAlert Clinical Surveillance System.

3. Description of the Supplies or Services: The Department of Veterans Affairs (VA), Veterans Health Administration (VHA) has a requirement for the FedRAMP compliant brand name Bitscopic PraedAlert Clinical Surveillance System, with associated services necessary for development and deployment of the solution, that interfaces with existing data resources, for example, Veterans Health Information Systems and Technology Architecture (VistA), Computerized Patient Record System (CPRS), Picis, Bed Management, and Bar Code Medication Administration (BCMA). The Bitscopic PraedAlert Clinical Surveillance System shall have the flexibility and scalability to interface with systems not yet established (e.g., Cerner) to provide real time data and predictive analytics to enhance clinical decision making. The system/product shall allow at least 25 users to simultaneously access and utilize multiple data resources to filter real-time data to create alerts, determine appropriate treatment or care algorithms, conduct queries, and pull a variety of information related to the following: ongoing clinical surveillance and monitoring of healthcare associated infections, influenza, emerging infectious diseases and antibiotic resistance trends, daily alerts, trending, analysis, documenting, and reporting to support mission critical activities within the Infection Prevention and Control (IP&C), Infectious Disease (ID), Pharmacy, Antimicrobial Stewardship Program (ASP) and Quality and Safety (QS) programs at VA Palo Alto Health Care System (VAPAHCS). The solution shall provide clinical staff with immediate real-time lists of patients, identify those patients who need clinical interventions and to provide the ability to protect those patients from adverse events and drug interactions. The period of performance (PoP) shall be a 12-month Base Period with one (1) 12-month Option Period and two (2) Optional Tasks for training requirements and developmental support. The total estimated value of the proposed action, inclusive of all option periods and optional tasks is $.

4. Statutory Authority: The statutory authority permitting other than full and open competition is 41 U.S.C. 3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) 6.302-1 entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.”

5. Rationale Supporting Use of Authority Cited Above: The proposed source for this acquisition is Bitscopic Inc., 715 Colorado Ave Ste B, Palo Alto, CA, 94303-3907, the

Clinical Software Surveillance and Control Number TAC-20-51539 Database Management System

Original Equipment Manufacturer (OEM). Bitscopic, Inc., confirmed that only itself or Epoch Concepts, LLC, its sole reseller, could provide the required PraedAlert software Solution. However, Epoch Concepts, LLC, a Service Disabled Veteran-Owned Small Business (SDVOSB), does not meet the 15 percent of work requirement for Value- Added Reseller (VAR) services under North American Industry Classification System (NAICS) 541519, and accordingly cannot provide the required software and associated services. Therefore, Bitscopic Inc., a small business, is the only source for this requirement.

Currently, the process for clinical surveillance is compiled by manually extracting information from VistA and other data sources, which is burdensome. When possible, the information is transferred manually by extracting and importing data to a Microsoft spreadsheet or other document type. Due to complex algorithms that require pre-sets of individual and grouped data elements to be matched, certain activities such as drug-bug mismatch or antibiograms are not possible or are not completed in less than a yearly timeframe. There is also overlap in some of the information that programs/disciplines, including IP&C, ID, Pharmacy and ASP, utilize adding redundancy and inefficiency to the current manual process that must also be taken into account.

This process is labor intensive and leaves the program subject to human error.

Consequently, there is no current automated system in place to measure or gather baseline data to conduct analysis, determine appropriate interventions, quantify results of interventions, determine efficiency, effectiveness, and cost benefits of interventions in an efficient and timely manner. The acquisition of the desired software and support would provide this functionality and positively impact the facility’s ability to improve patient care and patient safety by minimizing and effectively managing patients’ at risk for hospital associated infections (HAI), and improving workflow and care team collaboration and productivity for improved patient outcomes.

Extensive market research, further detailed in paragraph 8 below, determined that only the brand name Bitscopic’s PraedAlert Clinical Surveillance System can meet all of VA’s functional requirements. The first function only PraedAlert can provide is the ability to interface with non-VistA domains. For instance, no other product can interface with Picis, a non-Vista domain data source. Picis is a software suite utilized by the perioperative, critical care team and emergency room staff to electronically document patient care information, such as temperature, pulse, respirations, blood pressure, and ventilator settings. Staff in these areas also document other pertinent information, such as device insertions, care and maintenance. IP&C, ID, Pharmacy and ASP professionals utilize this program to conduct surveillance and investigate source of hospital associated infections.

Additionally, the Bitscopic PraedAlert Clinical Surveillance System is the only product that can ensure compliance with directive standards for Infectious Disease, Pharmacy and ASP by utilizing the PraedAlert product to evaluate antimicrobial utilization and resistance trends over time, and to evaluate the impact of multiple policy, formulary, personnel/staffing, and other clinical practice changes and interventions over variable time periods, in some cases up to three (3) years back in time. In order for ID, Pharmacy and ASP to create and analyze antibiograms, historical data is required to identify trends that are often used as benchmarks or areas of concern for which to implement quality improvement initiatives. For example, prospective analysis of such trends allows for analysis of the impact of new CPRS order set/algorithm or intervention implementations. The ASP Taskforce is often involved in research requiring the ability to do customized queries and to prepare antibiograms to ensure program success. For antimicrobial use and outcomes within institutions, reporting includes local antibiotic data, which is managed locally to determine patterns and then reported to the Centers for Disease Control, which is managed nationally. This provides oversight into the country’s population for antibiotic trends and data. Market research described in paragraph 8 indicated that no other company has responded with a product able to provide the critical requirement of the abililty to support a Picis interface.

HAI and infections with resistant organisms are associated with increased mortality, excess hospital stays, and increased health care costs. Therefore, if the brand name Bitscopic PraedAlert Clinical Surveillance System is not procured, VAPAHCS will not be compliant with the following VHA Directives:

• VHA Directive 1031: Antimicrobial Stewardship Programs;

• VHA Directive 1131: Management of Infectious Diseases and IP&C Programs,

• VA Memo Participation in VHA Efforts to Reduce Hospital Acquired Infections

Addtionally, VAPAHCS will not be able to support processes and systems to maintain compliance with Joint Commission (TJC) accreditation standards, the Long-Term Care Institute (LTCI), and the Office of the Inspector General (OIG), along with other surveying/compliance governmental bodies.

Furthermore, VAPAHCS will not be able to meet VA/VHA Strategic Plans and Agency Priority Goals and Key Results Indicators sections in accordance with Business Epic #298.

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. There is no competition anticipated for this acquisition. Additionally, the proposed action will be synopsized on the beta.SAM.gov website in accordance with FAR 5.201. Any proposals that are received shall be evaluated.

7. Actions to Increase Competition: The Government will continue to conduct market research to ascertain if there are changes in the market place that would enable future actions to be competed. Specifically, the Government will continue to monitor the marketplace to determine whether other brand software could interface with systems not yet established (e.g. Cerner) to provide real time data and predictive analytics to enhance clinical decision making.

8. Market Research: VA issued a Request for Information (RFI) with a draft Product Description (PD) on August 16, 2019 to open market contractors through the Federal Business Opportunities Page to ascertain the ability of any other source to provide an alternate product. On August 21, 2019, the RFI was extended to August 28, 2019. The RFI closed on August 28, 2019 and five (5) responses were received, including one (1) Service-Disabled Veteran-Owned Small Business (SDVOSB), two (2) small businesses and two (2) large businesses.

CliniComp International, Inc., a large business, proposed a solution that did not indicate compliance with the Picis interface requirement or the two (2)-to-three (3)-year lookback and access requirement. Document Storage Systems, Inc. (DSS), a large business, proposed the Theradoc solution that did not indicate compliance with Picis interface requirement or two (2)-to-three (3)-year lookback and access requirement. Priority 5 Holdings, Inc, a small business, proposed a Commercial-Off-The-Shelf (COTS) solution that did not indicate compliance with the Picis interface requirement or the two (2)-to-three (3)-year lookback requirement. Innovar Healthcare Systems Group, Inc., a SDVOSB, did not provide a solution that indicated compliance with any of the required functional requirements and would require significant enhancements, including many of the interfaces, be built in order to meet’s VA’s needs.

Accordingly, the Government’s technical experts determined that the Bitscopic, a verified small business, PraedAlert Clinical Surveillance System was the only respondent capable of meeting all of the Government’s functional requirements.

Additional market research was conducted in March 2020 utilizing the National Aeronautics and Space Administration (NASA) Solutions for Enterprise-Wide Procurement (SEWP) V Governmentwide Acquisition Contract (GWAC) Provider Lookup Tool to confirm if there were multiple resellers of Bitscopic, Inc. products. Only Epoch solutions, or the Original Equipment Manufacturer (OEM) Bitscopic, were identified as capable of sources for Bitscopic. However, after further analysis, Epoch was determined to fail to meet the 15% Value Added Reseller (VAR) minimum requirement under the NASA SEWP V GWAC North American Industry Classification System (NAICS) code 541519 and accordingly was not a capable source of supply for the required Bitscopic product. Accordinly, only the OEM itself, Bitscopic, a small business, was determined capable of meeting VA’s requirements. In addition, the Vendor Information Pages (VIP) database was reviewed in March 2020 for SDVOSB and Veteran-Owned Small Business (VOSB) vendors using the NAICS code 541519 and keyword PraedAlert. The VIP search yielded no matches.

VA issued a second RFI on March 19, 2020 to open market contractors through beta.SAM.gov to ascertain the ability of any source other than Bitscopic or Bitscopic resellers that could provide the requirements described above. The RFI closed on March 23, 2020 and one (1) response was received from the OEM, Bitscopic, Inc., who confirmed that the required PraedAlert software Solution can only be provided via the open market by itself Bitscopic, Inc., a small business, or via NASA SEWP V GWAC through their only authorized reseller Epoch Concepts, LLC, a VIP-verified SDVOSB, who does not meet the aforementioned 15% of work VAR services requirement.

Additional market research was conduct in June 2020 to ascertain if any other products could meet the requirements described above. An online search for similar products provided by other manufacturers, such as Sentri7, Meditech, Epic, Ambient Clinical Analytics, VigiLanz, BD MedMined Surveillance and DSS, did not provide any sources that could meet VA’s requirements. None of the solutions indicate compliance with the Picis interface requirement or the two (2)-to-three (3)-year lookback and access requirement. Additionally, Sentri7, Meditech, Epic, Ambient Clinical Analytics and VigiLanz did not currently interface with VHA’s electronic health record systems. Based on the above, only brand name Bitscopic PraedAlert Clinical Surveillance System meets all of the VA’s requirements.

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.

Date: ___________________________

Signature: _______________________

11. Fair and Reasonable Cost Determination: I hereby determine that the anticipated price to the Government for this contract action will be fair and reasonable based on comparing the quote to the Independent Government Cost Estimate. Additionally, price discounts will be sought.

Date: ___________________________

Signature: _______________________

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

Date: ___________________________

Signature: _______________________

Approval

In my role as procuring activity Advocate for Competition, based on the foregoing justification, I hereby approve the acquisition for the purchase and implementation of brand name Bitscopic PraedAlert Clinical Surveillance System on an other than fair opportunity basis pursuant to the authority cited in Section 4 above, subject to availability of funds, and provided that the property and services herein described have otherwise been authorized for acquisition.

Date: ____________ Signature: _________________________________

Advocate for Competition Technology Acquisition Center

Office of Procurement, Acquisition, and Logistics