JA_LSRP Redacted 2_7_23.pdf

VA-23-00007323

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:

This proposed sole source action is for the award of a firm-fixed-price contract to Cerner Government Services, Inc. (hereafter referred to as Cerner) for continued Remote Hosting, Maintenance, and Sustainment of Laboratory System Re-engineering Project (LSRP) Software.

This acquisition specifically will procure a Commercial off the Shelf (COTS) laboratory management system that is designed, built, and maintained by Cerner .

Cerner does not offer this software as a stand-alone suite that can be run on internal government IT architecture, rather, this software is a SaaS product and is hosted by Cerner.

NOTE: The Cerner LSRP implementation is a Commercial Off-The-Shelf (COTS) application is interfaced with VistA and other VA systems. The LSRP COTS software is not modified by the VA and the intellectual property rights are retained by Cerner Government Services.

Specifically, this proposed action acquires the following:

1. Remote hosting of the current LSRP implementation in the Cerner cloud, and

2. LSRP system administration and management services

3. LSRP disaster recovery and continuity of operation implementation, and

4. LSRP software licenses/subscriptions, and

5. LSRP technical support.

3. Description of Supplies or Services:

VA requires Remote Hosting, Maintenance, and Sustainment for LSRP Software.

LSRP is a laboratory information management system (LIMS) that interfaces with VA s Veterans Health Information Systems and Technology Architecture (VistA) and

. The LSRP software supports laboratory specimen collection, processing, and testing. The hosting environment is required to meet all applicable VA specifications as well as minimize short- and long-term risks regarding application availability and disaster recovery. Currently, VA requires hardware/software sustainment services and operational hosting of the LSRP. This includes monthly status and on-boarding reports, remote hosting and maintenance, disaster recovery implementation and support, technical support (24/7/365), cyber security implementation and maintenance per VA Authority to Operate (ATO) requirement, network and application support, and testing, capacity planning, and operations and maintenance support. This action is for the procurement of one (1) COTS software subscription covering the Production, Pre- Production, and Development environments. The period of performance of the proposed action is a 12-month base period with two (2), 12-month option periods.

The total estimated value of the proposed action is , inclusive of the option periods.

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

One Responsible Source and No Other Supplies or Services Will

5. Rationale Supporting Use of Authority Cited Above:

The proposed source for this action is Cerner, 10200 Abilities Way, Kansas City, Missouri. Cerner is the only source capable of providing the remote hosting and associated hardware/software sustainment services proprietary software product. Specifically, Cerner is the original software developer and intellectual property (IP) owner and does not authorize any other source to modify its proprietary source code. Cerner is therefore the only source with access to the necessary proprietary data elements and systems to design, modify/customize, configure, test, implement, and deliver continued sustainment and maintenance of the software product. Without complete access to the application and database and business rules, including source code, any software changes would introduce an unreasonably high risk of potentially compromising the confidentiality, integrity, and availability of personally identifiable information (PII), protected health information (PHI) and other critical VA sensitive data used in the direct care of the Veteran that affect patient safety and real-time critical lab results that are relied upon by VA Providers.

Additionally, any systems and source code to ensure that the two interfaced Electronic Health Records receive and interoperate according to complex business rules and clinical workflow of LSRP.

Due to proprietary constraints, the use of any other services/maintenance would require a complete replacement of the existing LSRP infrastructure at an exorbitant cost to the VA which includes the reestablishment of the aforementioned interfaces.

This duplicative cost is estimated to exceed $20 million in development and dual-system sustainment expenses alone. This estimated duplicative cost is based on previous acquisition history and would not be recovered through competition.

The VA requires continued maintenance for the Cerner LSRP implementation. This maintenance task ensures geographically dispersed VistA Health Level 7 (HL7) restricted network. This task also ensures the data is properly structured, computable, and formatted syntactically and semantically according to implemented National Standards. Cerner is the only source capable of providing this support and maintenance.

NOTE: Even if there was another provider or if the VA decided to recreate the software by designing, building, and deploying a custom solution, the same HL7 and VistA integration work would have to occur. This work is estimated to take a minimum of approximately 23 months to accomplish. Specifically, based on previous acquisition history, VA estimates approximately 3 months would be required for requirements definition and validation, approximately 12 months for design and development, approximately 1 month for customer acceptance testing, approximately 3 months for Initial Operating Capability Testing at two operational VA facilities, approximately 1 month for National and OIT Release approvals, and approximately 3 months to accommodate a phased national release. Further, VA would need to maintain the current product during the build and deployment phase.

The cost of maintaining the current system and building/testing/deploying a new solution is estimated to be $20M over the course of 2 years. This cost and the fact that the larger Cerner EHRM effort will replace this functionality in the upcoming years are the direct factors leading to this Justification for Other than Full and Open Competition.

Failure to renew the required Cerner Remote Hosting, Maintenance, and Sustainment of LSRP Software would cause most if not all laboratory functions to cease because there would be no connectivity to the EHR, resulting in manual recording of laboratory results, which introduces unacceptable levels of human error into this process. Additionally, and as stated above, failure to renew these services would introduce an unreasonably high risk of potentially compromising the confidentiality, integrity, and availability of personally identifiable information (PII), protected health information (PHI) and other critical VA sensitive data used in the direct care of the Veteran that affect patient safety and real-time critical lab results that are relied upon by VA Providers.

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 potential sources that can meet the other than Cerner. There is no competition anticipated for this acquisition. Additionally, the proposed action will be synopsized on the Contracting Opportunities Page in accordance with FAR 5.201. Any proposals that are received shall be evaluated. The ordering activity will make publicly available the justification along with the solicitation in accordance with FAR 6.302-1(c).

7. Actions to Increase Competition:

The Government had anticipated replacing the LSRP alpha site solution currently in use at the Huntington, WV, VAMC between 2017 and 2018 with an interoperable VA-Department of Defense (DoD) integrated Electronic Health Record (iEHR) Lab solution. However, several unanticipated events occurred during the past three years that have rendered the iEHR Laboratory solution as a non-viable replacement option. VA began planning the replacement requirement for a new system however, this requirement was centered on VA utilizing VistA. This was to be the enterprise-wide lab solution to replace VistA Lab. It was to be a competitive procurement with award and development commencing in fiscal year 2017 and implementation schedule in 2018. However, in 2017 VA determined that VistA could no longer meet requirements.

On June 5, 2017, then Secretary of Veterans Affairs Dr. David J. Shulkin announced what is known as a Determination and Findings (D&F), the D&F notes that there is a public interest exception to the requirement for full and open competition and determined that the VA may issue a solicitation directly to Cerner Corporation for the acquisition of the EHR system currently being deployed by DoD, for deployment and transition across the VA enterprise.

In May 2018, the VA Office of Electronic Health Record Modernization (EHRM) awarded Cerner Government Services, Inc. a contract for commercial off the shelf (COTS) Millennium EHR to replace the VA 40+ year old legacy VistA EHR. The new Cerner Millennium EHR contains software that is slated to replace the current LSRP solution that is being supported under this proposed action. It is anticipated that EHRM will replace the existing LSRP in the 2025 timeframe.

The larger Cerner/EHRM effort at the VA is highly complex and heavily governed by Congress and various Federal oversight groups. This contractual effort is directly aimed at mitigating this time-consuming process and bridging the gap until the Cerner/EHRM conversion is complete. OIT will also ask that the Huntington VAMC be prioritized in the Cerner/EHRM schedule.

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:

Over the last 12 months, specifically between January 2022 and October 2022, the web-based market research to review similar LSRP solutions from alternative vendors including those from Booz Allen Hamilton, Inc., Cognosante MVH, LLC, Ellumen Inc., HP Enterprise Services, LLC;

Liberty IT Solutions, LLC, and Leidos Inc.

concluded that none of these vendors were capable of providing Remote Hosting, System Management Services, Application Management Services, Disaster Recovery, end user license agreements (EULA)/ software subscription, management and technical support for the current Cerner LSRP implementation.

Specifically, none of these sources have the necessary access and/or hosting infrastructure to perform the requirements without a complete replacement and development effort as detailed in Section 5 above. VA verified in December 2022 that Cerner will not provide any other source access to its software solutions, hosting environments, or client databases based on the proprietary nature of the source code and database structures within its hosting infrastructure.

Additional Market Research was conducted through issuance of a Request for Information (RFI) on the Contracting Opportunities website on October 26, 2022.

The RFI closed on November 4, 2022, and no responses were received. Based on the market research, have determined that only Cerner Government Services, Inc. can requirements.

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.

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 price analysis to include comparison of negotiated prices to the Independent Government Cost Estimate and historical pricing.

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

Approval

In my role as procuring activity Advocate for Competition, based on the foregoing justification, I hereby approve the acquisition of Hosting, Maintenance, and Sustainment for Laboratory System Re-engineering Project Software, on an other than full and open competition basis pursuant to the statutory authority cited in Section 4 above, subject to availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.