P03 - J and A - Data Innovations initial DL - JB2 FINAL REDACTED.pdf

Data Innovations VA-25-00011779

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 firm fixed priced delivery order to be placed against National Aeronautics and Space Administration (NASA) Solutions for

Enterprise-Wide Procurement (SEWP) V Government Wide Acquisition Contract (GWAC) for the purchase of brand name Data Innovations (DI) Instrument Manager (IM) software licenses, maintenance, and support services for five locations within Veterans Intagrated Health Network (VISN) 17.

3. Description of the Supplies or Services: VA VISN 17 requires the renewal of five DI IM software licenses, maintenance, and support services.The DI IM software is the middleware that allows laboratory tests to run on complex automated analyzers to be downloaded to the VA Veterans Health Information Systems and Technology Architecture (VistA) computer system without any operator intervention. The support and maintenance services allow for Health Level Seven (HL7) messaging development of rules necessary for auto-verification of patient test results and data pulls and moving averages to support the auto-verification capabilities within the DI middleware system, installation, and configuration support for DI IM software license on middleware systems (Production, Shadow, Test, and Reports Manager). The DI IM software license maintenance is required in order to provide continue support to the licenses which allows for: nonemergency telephone support from 9 am to 8 pm EST, 24x7x365 emergency support, software patches/updates, enhancements and new release versions, individual login credentials for accessing customer web portal to submit and track requests for support, availability of online knowledge base, and driver download web page for new and updated drivers.The base period of performance (PoP) for this effort is March 1, 2025 to February 28, 2026, plus four 12-month Option Periods for continued DI IM maintenance support and consulting services, if exercised. The total estimated value of the proposed action is $872,405.67, inclusive of Options.

4. Statutory Authority: Pursuant to Federal Acquisition Regulation (FAR) 16.505 (a)(4), the subject 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 extensive market research, as described in Section 8 of this justification, it was determined that DI is the only company that can provide the requiredsoftware licenses, maintenance and support services. The DI software is currently in use in VISN 17 and is essential in the

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Rectangle operations of VISN 17. DI or an authorized reseller are the only vendors that can provide continued support to middleware due to proprietary software and intellectual property rights. Third-party technical services are not authorized to provide the required maintenance. No other software is currently compatible with VistA HL7 messaging protocol.. Furthermore, only DI possesses the interoperability to ensure laboratory tests are downloaded to the VistA computer system without any operator intervention.

No other solution other than DI fully meets the governments solution; furthermoreIf there were an alternative software solution identified this would require all VISN 17 laboratories to procure new software, re-write all existing software drive rules, conduct extensive interface tests of the new software. The estimated duplicated cost to change to a different software for the same required outcome would be approximately over $10 million, which does not consider another software provider’s costs to develop interoperability with VistA. This estimate is based on previous efforts to create the existing infrastructure.

Any change to the Governments required solution would necessitate a enterprise wide project and structured change management as due to the widespread usage and complex interations the DI software has with the VA IT infrastructure a customized and well tested solution would be required; the acquisition of such a solution which would take up to two years to award following approval of the project, followed by the development of the solution post award which would take up to an additional year, followed by the VA Approval to Operate process, which could take up to two additional years; therefore the Government seeks to implement a base plus four option year solution. Futher, if a alternative solution is developed and implemented before the use of all options, the structure of options will allow a seamless transition as all options are not required to be used. Therefore, aforementioned redesign of the infrastructure would result in extensive estimated delivery delays of five years or more. This type of change would not be cost-effective. Furthermore, any malfunctions of the DI software would result in a significant delay in the availability of Veterans laboratory test results. It would require manual test result data entry into VistA. This is a patient safety concern, as errors of manual data entry increase because of transcription errors. Accordingly, only DI software and maintenance support can satisfy VA’s requirements discussed above without substantial duplication of the cost that could not be recovered through competition. With respect to the DI IM software maintenance, module, and connections support required by this procurement, the DI IM is the only software maintenance available that meets the Government’s current requirements. If the aforementioned software maintenance is not obtained VISN 17’s DI IM software would not be able to remain operational.

Only software licenses, support services, configuration, 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 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. 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 17 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 has been continuously conducted by VA technical experts since 2021 to determine if competition was viable for this action with the most recent research in October 17, 2024. While some products, such as JResultNet, Synapse Link, and Sysmex., possessed some similar capabilities to perform the proposed effort, they were not able to meet the need to download lab values to the VISTA architecture without any operator intervention. Furthermore, these three companies only were able to report lab values from specific tests or specific machines, and therefore would not be compatible with VA’s extisting infrastructure.

Based on the fact that DI owns all intellectual property rights in the DI Products and does not support third-party technical services, 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.

In addition to the software liscencing, the Government requirement includes maintenance and support systems; DI like many other software developers with a proprietary system offers associated services such as software maintence and support services that will only operate with its respective software which is limited to the software provider and their authoritied resellers.

Therefore, It was determined that no other vendor can provide the required brand name DI software licenses, maintenance, and support services 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. 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.

Additionally, the Government discussed the ability of resellers to provide the required product and services. Data Innovations has established a Small Business reseller partnership with Four Points Tech, LLC to meet the needs of the VA throughout the

United States, with regard to SDVOSB set asides. Four Points currently provides contract administration services to a large number of Instrument Manager customers across the VA. They are currently the only authorized SDVOSB reseller of DI Products on NASA SEWP to the VA. Additionally, DI has confirmed that Four Points is the only reseller who can license and distribute their software and services standalone.

9. Other Facts: Intentionally left blank.

10. Technical/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.

Zhenze Zhao Date Laboratory Manager

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.

David A. Long Date Contracting Officer

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

David A. Long Date Contracting Officer

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Approval

In my role as procuring activity Advocate for Competition, based on the foregoing justification, I hereby approve the purchase of brand name Data Innovations (DI) Instrument Manager (IM) software licenses, mainetenance, and support services 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.

Jason Bullen Date

Advocate for Competition Technology Acquisition Center Office of Procurement, Acquisition, and Logistics Department of Veterans Affairs