DA01--VISN 10 Data Innovations Autoverification Licensing and Maintenance (VA-23-00002902)

VISN 10 Data Innovations Autoverification Licensing & Maintenance (VA-23-00002902) 2 VA-23-00002902 JUSTIFICATION FOR AN EXCEPTION TO FAIR OPPORTUNITY 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 action is for a sole source delivery order to be placed against National Aeronautics and Space Administration (NASA) Solutions for Enterprise-Wide Procurement (SEWP) V Government Wide Acquisition Contract (GWAC) NNG15SD22B for brand name Data Innovations (DI) Instrument Manager software licenses, installation, configuration, workflow and Auto-verification (AV) rules development, training, project management, maintenance and Electronic Health Record Modernization (EHRM) implementation with Four Points Technology, LLC. (Four Points), 14900 Conference Center Drive, Chantilly, Virgina. 3. Description of the Supplies or

Services: VA, Veterans Integrated Service Network (VISN) 10 Pathology & Laboratory Medicine Services (PLMS) has a requirement to procure DI software licenses, installation, configuration, workflow and AV rules development, training, project management, maintenance, and support with EHRM Implementation. This effort encompasses 11 total facilities within VISN 10. Instrument Manager is the software that is currently utilized within VISN 10 for AV, which provides a process for automatically verifying test results based on a predetermined set of rules established by the laboratory. VA requires additional expansion of this capability to improve operational efficiency by eliminating the need for a medical laboratory physician or technologist to approve each test result before it is released to the laboratory information system for reporting. In general, with AV, patient results generated by an instrument interfaced to a laboratory information system are compared by computer software against laboratory-defined acceptance parameters (rules). If results fall within these parameters, they are automatically released for reporting with no additional human intervention. VISN 10 conducts tests for Chemistry, Coagulation, Hematology and Microbiology and Urinalysis test specialties. Without AV capability, medical technologists have to manually review, approve and enter results into patient records. The Contractor's installation team will work with VISN 10 engineers, technicians, laboratory scientists, Information Technology staff and network engineers to set up, configure and test the lab instruments with the DI Instrument Manager software to validate that end-to-end lab tests orders, results, and quality control metrics are all connected and functioning in an accurate and optimal manner at the VISN 10 facilities. Training needs will vary by site needs but shall consist of basic training on the Instrument Manager software, Introduction for Rules Management, and Intermediate Rules for Instrument Manager within VISN 10. Configuration involves providing device configurations for the Instrument Manager Software. Software Maintenance is different per each facility, but examples include maintenance for testing to improve system performance and detecting any issues, to include resolving those issues, as well as maintenance enhancement of existing features of the software. The Contractor shall provide brand name DI components (licenses and services). The Contractor shall perform the VISN10 AV effort throughout the period of performance to accommodate the changing EHRM Implementation across the VISN. Due to the complexity of work that needs to be completed by the Laboratory Information Managers (LIMs), a longer period of performance is required to ensure the work can be completed. Low Complexity Workflows can take an average of 2-5 months, High Complexity Workflows can take an average of 6-9 months. In addition to these AV Workflows there are additional software features like Moving Averages, CAP eLab Solutions, and software upgrades that require additional time. There are three levels of training and education that can be purchased through DI and are included in this contract. The Intermediate level training has a requirement of the Intro and Basic training, at least 6 months of a LIM managing an AV workflow, and a pre-test that must be passed in order to take the course. There are a total of 6 AV Workflows and some sites have all workflows to try and complete during the contract in addition to training, the additional software features, and Cerner Migration of all Data Innovations software and AV workflows. The period of performance shall be one 12-month base period, with four 12-month option periods and optional tasks to be exercised at the Government s discretion. These optional tasks are required to ensure the sites are able to operate the latest version of Instrument Manager (IM) for continuity of services. The total estimated value of the proposed action is $, inclusive of the option periods and optional tasks. 4. Statutory Authority: Pursuant to Federal Acquisition Regulation (FAR) 16.505(a)(4), the following brand name requirement is being justified and approved as an exception to fair opportunity under the statutory authority of Section 41 U.S.C. 4106(c)(2) as implemented by FAR 16.505(b)(2)(i)(B), entitled Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized . 5. Rationale Supporting Use of Authority Cited Above: Based on market research, as described in paragraph 8 of this justification, it was determined that there is no competition for the required brand name DI software licenses, installation, configuration, workflow and AV rules development, training, project management, and maintenance. The DI software is currently used by all of VISN 10's sites for interfacing common laboratory equipment with the VistA laboratory platform. No other software is currently able to provide the required interface with VistA and is compatible with Cerner as the VISN 10 sites transition their Electronic Medical Record from VistA to Cerner. VISN 10 is comprised of 11 facilities: Northern Indiana, Dayton, Cleveland, Indianapolis, Detroit, Battle Creek, Ann Arbor, Saginaw, Cincinnati, Chillicothe and Columbus. Each of these sites currently utilize the proprietary DI software, and are in various phases to achieve AV. VISN 10's infrastructure consists of the DI Software and the procurement of another vendor's systems and software would require a completely new infrastructure and impose significant technical risk as VA would have to implement that brand's entirely new software suite. Due to proprietary constraints, the use of any alternative software solution would require the replacement of existing infrastructure including light poles, serial cables, and servers that have been specifically configured to work only with brand name DI software. These replacement of this hardware would produce estimated duplicative costs of approximately $945,000. This estimate of duplicative cost is based on previous acquisition history. Additionally, many of the sites within VISN 10 have also procured additional hardware that has been configured to work w/ DI which would also need to be replaced. Further, based on historical efforts, any alternative vendor would require a significant development effort of 2-3 years to develop the software interfaces in both in production and live environments, conduct connectivity testing validation testings with equipment, and redevelop Autoverification workflows, and additional add on features that facilities currently operate. More specifically, any alternative vendor would need to duplicate 9 high complexity and 8 low complexity workflows that have already been completed and are currently utilized. Based on previous acquisition history, VA technical experts estimate that this significant redevelopment effort would produce additional duplicative costs of $430K in addition to the duplicative hardware costs identified above. Additionally, DI is the only software which has completed the New Service Request process to be approved by the Elecrtonic Health Record Modernization Integration Office (EHRM IO) and VHA to have interface capabilities with Cerner. Historically, this is a lengthy process that requires between 15-18 months for a new software to be approved. DI is currently the only vendor with this type of software that has been approved to work with Cerner. This process could not be accomplished concurrently with the development effort discussed above. Lastly, no other brand name software licenses will be able to meet VA's interoperability and compatibility requirements. Specifically, no other brand name software would be able to communicate and function with the currently fielded DI software licenses due to proprietary constraints within the software and its integration with the AV process. Only software maintenance and premium technical support services provided by DI or a reseller can meet the requirements as the existing software is proprietary to DI. Only installation, configuration, workflow and Auto-verification (AV) rules development, training, project management, and maintenance support provided by DI, or a reseller, can meet the requirements as the existing software is proprietary to DI. Specifically, without access to DI proprietary source code, no other source is able to provide access to the Customer Web Portal for drivers, upgrades, patches, along with access to the DI Support Line. Additionally, since the software is proprietary, no third-party source exists that provides analysis, troubleshooting, and resolution of any software product-related problems other than an DI reseller. If VA is unable to procure the required DI software and services, VA will have to revert to manual verification of each specimen test result. This manual process increases the likelihood of errors and increases the amount of time to provide test results for providers and Veterans and possibly delay treatment options. This will significantly increase the technician workload within the lab, which is a position that currently has a national shortage. This additional workload could also add additional burden resulting in higher turnover rates, lower morale, and the potential need to send specimens to an outside referral lab for processing, which would increase other contract costs. Most importantly, errors and increase in cycle time to verify specimen test results would negatively impact patient care offered to Veterans and could lead to serious health complications. 6. Efforts to Obtain Competition: Market research was conducted, details of which are in section 8 of this justification. This effort did not yield any additional sources that can meet the Government's requirements. There is no competition anticipated for this acquisition. In accordance with FAR 5.301 and 16.505(b)(2)(ii)(D), the award notice for this action will be synopsized on the Contracting Opportunities Page and the 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 market place that would enable future actions to be competed. VISN 10 will continue to research and monitor whether there are emerging products that enter the marketplace that are interoperable and compatible with the existing DI software licenses. 8. Market Research: Market research was conducted by VA technical experts between December 2021 and January 2022, by researching similar products via internet catalog research and reviews such as those from Oracle and Orchard Software. Based on this analysis, the VA technical experts determined that no other brand name software would be able to communicate and function with the currently fielded DI software licenses due to proprietary constraints within the software and its integration with the current DI system. Additionally, no other vendors can provide the required software required to interface with VistA. VA technical experts reviewed similar products from alternative vendors including those from Oracle and Orchard Software to determine whether any other sources can provide DI installation, configuration, workflow and AV rules development, training, and maintenance. After review, it was determined that no other vendor can provide the required brand name DI installation, configuration, workflow and AV rules development, training, project management and maintenance due to the proprietary source code, no other source is able to provide access to the Customer Web Portal for drivers, upgrades, patches, along with access to the DI Support Line to the proprietary DI software. Each software developer offers a proprietary system and associated services that will only operate with its respective hardware and software. Based on this market research, only DI or resellers of DI can meet VA technical requirements. Therefore, no alternative vendor can avoid the duplication of effort and time as detailed in Section 5 of this justification. On September 8, 2022, Request of Information (RFI) 248692 was issued on NASA SEWP and published on System for Award Management (SAM) to conduct further market research. The RFI closed on September 15, 2022, with responses received from Four Points, an SDVOSB and an authorized reseller of DI, and Earth2Earth, LLC (Earth2Earth), a Women Owned Small Business. The response from Earth2Earth did not provide any technical information for review, therefore, the Contract Specialist emailed Earth2Earth back that same day requesting they address all questions outlined in Section B of the RFI, which included addressing the company s technical approach to meeting the requirement. Earth2Earth also failed to address questions relative to the company s intent and ability to meet the set aside requirements in accordance with VAAR 852.219-10 (NOV 2020) (DEVIATION) VA Notice of Total SDVOSB and 13 CFR §125.6, which states the contractor will not pay more than 50 percent of the amount paid by the Government to it to firms that are not SDVOSBs. Earth2Earth failed to provide any response to the Government email or provide any technical information or plan to meet VA s requirement. The response from Four Points was provided to the technical representatives and determined to be capable. In it s response, Four Points provided a letter from DI stating that Four Points is currently the only NASA SEWP V GWAC Prime Contractor authorized to resell DI products to the VA. A copy of this letter has been placed in the contract file. Additionally, the Contract Specialist contacted DI on October 3, 2022, to inquire if DI had any other resellers. DI confirmed the same day that while they have other partners who bundle certain aspects of DI products into their own offerings, Four Points is the only reseller who can license and distribute their software and services standalone. A copy of this correspondence has also been placed in the contract file. 9. Other Facts: None. 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: ________________________________ Health Systems Specialist Diagnostics 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.NASA SEWP V has already determined the prices on contract to be fair and reasonable. Additionally, the successful quote will be compared with the Independent Government Cost Estimate. 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. 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 Data Innovations software licenses, installation, configuration, workflow and Auto-verification rules development, training, project management and maintenance 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