IR212 1b- National HTM RALS - Redacted JA.pdf

Abbott RALS Software and Services Control Number: VA-21-00079711

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, New Jersey 07724

2. Description of Action: The proposed action is for a sole-source, firm-fixed-price contract with Abbott Rapid Diagnostics Informatics, Inc., formerly Alere Informatics, Inc.

(Abbott), the exclusive provider for brand name Abbott RALSTM Plus laboratory management software licenses, maintenance and professional support services.

3. Description of the Supplies or Services: The Department of Veterans Affairs (VA) Office of Electronic Health Record Modernization (OEHRM) provides program management and oversight for the replacement of the VA’s legacy electronic health record, VISTA, with the Cerner implementation of the new Electronic Health Record (EHR). As part of the EHR implementation, VA has a requirement to upgrade its existing Abbott RALS laboratory management system at various VA facilities throughout VISNs 12, 15, 17, 19, 21, 22, and 23 to interface and communicate with Cerner. RALS is a total solution system that manages patient results, quality control, linearity, operators, certification, devices, device configurations and more at the point-of-care.

VA’s Abbott RALS Plus laboratory management system hardware/software has been in place since 2007 and is currently in use across 140+ plus locations [comprised of Veterans Affairs Medical Centers (VAMCs), Regional Data Centers]. This system supports iStat handhelds, which are point-of-care, blood analyzers. Using special cartridges, the iStat can measure a large variety of blood parameters including, but not limited to, blood gases, electrolytes, lactate, and troponin, with most results available within two minutes. Point of care blood testing standardizes and consolidates testing across a variety of clinical settings, enabling rapid decision-making in the patient-care setting, streamlining workflows, and optimizing resource utilization. The requirements for this upgrade effort will consist of brand name Abbott RALS Plus add-on software along with maintenance and professional support services for 29 existing RALS management systems across the aforementioned VISN facilities. Specifically, the Contractor shall provide RALS Virtual Test System software licenses and maintenance support, Laboratory Information Systems (LIS) and ADT (Admission/Discharge/Transfer) Interface Upgrade software, as well as configuration, cut-over, and interface development services that will enable the iStat and other end-point device information to flow into the new VA Cerner EHR. The upgrade software and services will enable the Abbott RALS Plus laboratory management system to retain existing legacy RALS Plus laboratory database information, allow the database information to transition over to Cerner EMR, accept primary and secondary medical record number (MRN) workflow, and allow the system to co-exist with legacy databases. The add-on capabilities will also provide for new features required or recommended for optimal laboratory operation in a Cerner Electronic Medical Records (EMR) connected environment. The period of performance shall be 36 months consisting of a staggered upgrade schedule per facility.

4. Statutory Authority: The statutory authority permitting other than full and open competition is Section 41 U.S.C. 3304(a)(1) as implemented by the Federal Acquisition Regulation (FAR) Subpart 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 proposed action is Abbott Rapid Diagnostics Informatics, Inc. (Abbott), 2000 Holiday Drive, Charlottesville, VA 22901. Based on market research, as described in Section 8 of this document, the Government has determined that Abbott is the only source capable of providing the required software and services; therefore, there is no competition for this acquisition. Only Abbott add-on software and associated integration and cut-over services are capable of meeting VA’s requirements for this effort. As stated in Section 3, VA’s Abbott RALS Plus laboratory management system hardware/software has been in place since 2007 and is currently in use across 140+ plus VA medical facilities. This effort is only to upgrade the existing system at various VA facilities throughout VISNs 12, 15, 17, 19, 21, 22, and 23 which is required in order for the software to interface and communicate with Cerner. No other brand software can be used to upgrade the existing Abbott RALS Plus laboratory management system due to the proprietary nature of the system. Further, no other source is capable of providing the required configuration, cut-over, and interface development services as access to Abbott’s proprietary source code is required in order to ensure the services provided to the hardware and software components of the systems are properly configured. Failure to upgrade VA’s existing Abbott software throughout these VISNs will leave VHA without an integrated laboratory management system resulting in the need to transmit lab results/orders in a manual fashion to the new Cerner EHR. Any such manual intervention would significantly impact VA patient care as VA clinical staff are dependent on the existing Abbott system to analyze laboratory results for accurate diagnosis/trend tracking. Furthermore, replacing the existing system or implementing a new and separate laboratory management system for these VISNs to integrate with the new Cerner EHR would require an extensive implementation effort, including the replacement of all existing Abbott RALS Plus Endpoint Devices which are not compatible or interoperable with any other laboratory management software. Any such replacement or new implementation effort is estimated to cost $8M and take at least four years to complete. This estimate is based on previous implementation efforts of similar size and scope. Aside from this duplicative cost that would not be recovered through competition, and which would delay the Cerner transition for these VISNs, requiring VA lab technicians and managers to learn, operate and manage a new system and workflows as part of the Cerner integration would add unnecessary complexity and duplicative activities thereby compromising patient care.

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. The proposed action will be synopsized on the Contract Opportunities page in accordance with FAR 5.201. Any proposals that are received shall be evaluated. Additionally, in accordance with FAR 6.305(a) this Justification for

Other Than Full and Open Competition will be made publicly available on the Contract Opportunities page within 14 days after contract 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: The Government’s technical experts conducted market research in May and August of 2021 by reviewing laboratory management system available from other manufacturers including Data Innovations, Relymed, and UniPOC Siemens.

While similar systems exist, the market research confirmed that due to the proprietary nature of the existing Abbott RALS system, only brand name Abbott software and services can be used to upgrade the existing system to interface and communicate with Cerner and avoid the duplicative time and cost as outlined in Section 5 of this document. Based on this market research, VA’s technical experts confirmed that only brand name Abbott RALS software, maintenance and professional services can meet all of VA’s requirements for this effort. The Government also obtained a letter from Abbott dated July 7, 2021 confirming that Abbott is the sole supplier of their RALS System and associated services; therefore, no resellers exist.

9. Other Facts:

None.