(S03) JA_RALS_redacted.pdf

Control Number VA-20-0009195

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 Abbott Rapid Diagnostics Informatics, Inc., 2000 Holiday Dr Ste 500, Charlottesville, VA, 22901-3601, to procure eight (8) RALS- Web3 Test Systems for VISN20 hospital sites.

3. Description of Supplies or Services: The Department of Veterans Affairs (VA) Office of Electronic Health Record Modernization (OEHRM) requires Brand Name Remote Automated Laboratory System (RALS)-Web3 Test Systems and associated support and software maintenance in support of the VA Electronic Health Record Modernization (EHRM) project. OEHRM provides program management and oversight of the implementation of the VA’s new Electronic Health Record (EHR).

This is a firm-fixed-price contract for eight (8) systems in eight (8) Veterans Integrated Service Network (VISN) 20 locations.

Abbott Rapid Diagnostics Informatics Inc will provide all the necessary software, software licenses and support to install a full RALS-Web3 Test System on a virtual server(s) at each of the following VISN 20 sites:

• White City

• Walla Walla

• Spokane

• Seattle

• Roseburg

• Portland

• Anchorage

• Boise

VISN 20 is moving from the legacy Veterans Health Information Systems and Technology Architecture (VistA) EHR to an Enterprise Cerner EHR. This move will require legacy systems to have their existing medical and laboratory devices interfaced and configured to communicate with Cerner. The RALS Test Systems are required at each site in order to test the interfaces between point-of-care lab instruments and the Cerner Laboratory Information System (LIS) and other associated systems when RALS is interfaced with the Enterprise Cerner EMR in a test environment. Point-of-care lab instruments transfer data to the RALS system via a direct network connection, personal computer (PC) connection or a dataport, where it is evaluated and either sent directly to the VistA EMR or held for review. It is imperative that Test Systems are available at each site so that as new point-of-care devices are purchased, or upgrades are made to existing point of care devices, these changes can be thoroughly tested without impacting production systems. The Test System is also used to test changes to the RALS system itself.

RALS-WEB3 Test Systems Control Number VA-20-0009195

Abbott Rapid Diagnostics Informatics Inc will perform all tasks remotely through an already existing virtual private network (VPN) connection to the VA network. VA will host the RALS-Web3 Test System Core Server at each site. The Period of Performance for the RALS-Web3 Test System installation is five (5) weeks from contract award. The total estimated value of the proposed action 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 action is Abbott Rapid Diagnostics Informatics, Inc., 2000 Holiday Drive, Suite 500, Charlottesville, VA 22901. Based on market research, as described in Section 8 of this document, the Government has determined that Abbott Rapid Diagnostics Informatics, Inc., is the only source capable of providing the eight (8) RALS-Web3 Test Systems for VISN 20 hospital sites; therefore, there is no competition anticipated for this acquisition.

VISN 20 is moving from the legacy VistA EHR to an Enterprise Cerner EHR at VISN 20 sites. The RALS, a legacy system connected to the VistA EHR, is required to interface with the Enterprise Cerner EMR to continue to providing point-of-care instrument’s real-time results to VA healthcare providers, laboratories and updates to patient charts and billing systems. It is imperative that test systems are available at each site so that as new point-of-care devices are purchased or upgrades are made to existing point of care devices, these changes can be thoroughly tested with the Cerner EMR without impacting production systems. The test system is also used to test changes to the RALS system itself. RALS is the single data manager for multiple point-of-care instruments connected. RALS software communicates with multiple vendor point-of-care instruments data through Abbott’s proprietary source code. The RALS system is the only VistA legacy system that sends point-of-care instrument data to the VistA EHR. In order to test the Enterprise Cerner EHR interface, the test environment must be an exact replica of the production environment, while there are other vendor products that can provide the same capabilities and services as RALS, they can’t provide the specific proprietary test system that’s compatible and will work in the VA point-of-care infrastructure.

Therefore, Abbott is the only vendor that can provide a test system that replicates the production system as well as the requisite knowledge and expertise to test point-of-care instruments data transferred through their proprietary RALS system to the Cerner EMR. In addition, Abbott is the only source capable of providing access to the RALS proprietary source code necessary to develop, configure and implement software updates. RALS is the only system that supports multiple vendor point-of-care instrument services which are currently installed at over 121 VA sites.

Furthermore, no vendor test system is compatible or interoperable with the RALS proprietary database structures, protocols, and software application programming interfaces. Abbott’s RALS-Web3 Test System is the only test system capable of meeting the VA’s requirement of testing the interfaces between point-of-care lab instruments with the Enterprise Cerner EHR. Abbott does not license their proprietary message protocols to other vendors. The impact of not using RALS WEB3 Test System requires developing a new solution to provide point-of-care services at 121 VA facilities. Engineering a new solution would require replacing the RALS system at VA facilities, which is an extensive effort estimated at $1.7 million, based on replacing 121 RALS systems at $14,400 per system, and could not be feasibly accomplished without having a major impact on the VISN 20 schedule.

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 marketplace that would enable future actions to be competed.

8. Market Research: Market research was conducted in August 2020 by the Government’s technical experts to determine if other products could satisfy the VA’s requirements. Two (2) point-of-care data management systems; UniPOC™ Data Management System from Siemens Healthineers and Telcor QML were found by conducting an Internet search on point-of-care data management systems.

However none the vendors’ products can provide a test system that’s interoperable, compatible or identical to the VA’s point-of-care production environment and infrastructure that’s required to perform the testing of point-of-care instrument data transferred to the Enterprise Cerner EMR as discussed in Section 5 of this document. As a result of the market research the technical experts confirmed that RALS-WEB3 test system is the only system that can meet all of VA’s requirements for testing the RALS/Cerner EMR interface and provide a system compatible with existing VA infrastructure for the reasons discussed in Section 5. Further, the market research confirmed that Abbott Rapid Diagnostics Informatics Inc., is the sole manufacturer/distributor of RALS-WEB3 test systems and there are no resellers that can provide the required software licenses and maintenance support for this effort.

Additional market research was conducted in September 2020. The Vendor Information Pages database was reviewed for Service-Disabled Veteran-Owned Small Business (SDVOSB) and Veteran-Owned Small Business (VOSB) vendors, using the North American Industry Classification System (NAICS) code 541519, Other Computer Related Services, and keyword “RALS Test System,” yielding 241 matches, including 215 SDVOSBs and 26 VOSBs. However, the Original Equipment Manufacturer (OEM), Abbott Rapid Diagnostics Informatics, Inc., confirmed in a letter dated September 8, 2020 that there are no other resellers for the required RALS Test Systems, and they are not available on any existing contract vehicle. Additionally, the National Aeronautics and Space Administration (NASA) Solutions for Enterprise-Wide Procurement (SEWP) V Governmentwide Acquisition Contract (GWAC) Market Research Tool was utilized to confirm that the required RALS Test Sysem is not available under Abbott Rapid Diagnostics Informatics, Inc.’s, or any other, NASA SEWP contract, as suggested by the aforementioned OEM letter.

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 a comparison to historical prices paid and commercially available pricing for the software licenses and maintenance. The price will also be compared to the Independent Government Cost Estimate.

12. Procuring Contracting Officer Certification: I certify that this justification is accurate and complete to the best of my knowledge and belief. As this contract action does not exceed $700,000, the certification below required by FAR 6.303- 2(b)(12) serves as approval.