JA Narrative ETSSS_Ceiling Increase FINAL Redacted_Redacted.pdf

VA-24-00098659

LIMITED-SOURCES JUSTIFICATION

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 justification is for a modification to General Services Administration (GSA) Federal Supply Schedule (FSS) Enterprise Testing Service Support Services (ETSSS) Contract GS-35F-598GA, Order Number 36C10B20F0076, with Planned Systems International, Inc. (PSI), to increase the existing Hybrid, Firm-Fixed Price and Time & Materials (T&M) contract ceiling and Period of Performance for test support services in support of the Electronic Health Record Modernization (EHRM) Integration Office (IO) (EHRM-IO).

3. Description of the Supplies or Services: These test support services align with the Secretary, Veterans Affairs (SECVA) priorities including the Electronic Health Record Modernization (EHRM) program and current VA legacy systems that are foundational to EHRM-IO. EHRM is implementing strategy 4.3.5 within Strategic Goal 4 in the VA FY Strategic Plan Fiscal Year 2022-2028. The EHRM-IO is the program executive office charged with the preparation, deployment, and transition to a new electronic health record (EHR) within VA. The EHRM program will ensure that deployment of the new EHR is done in a manner that meets VA needs and supports seamless healthcare to Veterans and qualified beneficiaries. The modernized health record directly supports improved customer service to Veterans. The EHRM-IO Integrated Testing program (EHRM-IO IntT) manages and oversees the execution of the test and evaluation activities across the EHRM program and products. The contract services also support the independent testing of Office of Information & Technology (OIT) Software Product Management development projects across the SPM portfolios and projects. PSI currently provides 100 percent of the EHRM IntT enterprise testing workstream test services.

Block releases of software updates and fixes are released to production every 6 months and are critical to the improved functionality and security of the EHR software. There is ongoing testing of software updates that will not be completed in time for the August 2024 Block 11 release. Continued testing of priority software updates needs to continue without interruption to be ready for the Block 12 release in February 2025. Due to the complexities of the testing support and the number of capabilities and workflows required, this support is still ongoing, and is necessary to reach the upcoming Block 12 Code Upgrade release, which will deliver additional system integrations and critical outpatient pharmacy enhancements to the EHR capabilities on February 15, 2025. Testing services also are required for sustainment of daily operations testing such as the monthly break/fix package releases, testing of third-party system integrations upgrades, and complex build/configuration updates. In addition, the EHRM reset team has identified critical functionality updates including new code as well as build/configuration improvements required to restart deployments of the EHR in 2025. These reset items are high priority requiring ETSSS testing support. PSI currently provides the following ETSSS Services: test program management; test and evaluation services; test systems engineering and implementation; and test process and quality management for EHRM- IntT, EHRM-OIT System Integrations, and OIT Enterprise Program Management Office portfolios/programs. Currently, the majority of the ETSSS testing support PSI provides is for EHRM-IO Integrated Testing services.

The Block 12 code upgrade deployment covers a variety of technically complex topics covering numerous clinical, technical and functional workstreams, development projects and system interfaces within and external to Oracle Health and to VA. EHRM-IO testing services provided by PSI are foundational to the success of EHRM-IO Block 12 deployment on February 15, 2025.

ETSSS was originally awarded June 14, 2020, with a PoP of a 12-month base year and four, 12-month option periods. Currently, the last option period ends September 14, 2024. This modification will increase the PoP of the last option period to June 14, 2025. This increase will accommodate five months of full scope testing through February 14, 2025, and an extended transition out period to a new vendor if required. This modification will increase the ceiling by

. This increase supports continuation of OIT test services, and EHRM Block 12 code upgrade testing services, sustainment testing for operational EHRM sites and EHRM reset activities. Additionally, the modification to add ceiling will allow for a VA to exercise the existing Optional Task for transition out support if needed for the competitive contract. This Optional Task would be exercised when the new competitive contract is anticipated to be awarded in December 2024. This justification will raise the total contract ceiling from to which is a increase.

The contract ceiling was reached earlier than expected during the performance of the ETSSS order. The original ceiling was based on historical OIT testing workloads and included an estimated allocation for EHRM support. That EHRM allocation proved to be insufficient to support the unanticipated number of changes required to the commercial EHRM system to meet VA-specific requirements. When the original ETSSS ceiling was established, the testing processes and test and evaluation services were just being established within the Electronic Health Record Modernization Program. One site had just gone to production deployment at the time of the contact award and there had been no block code upgrades twice a year or post go-live sustainment testing. Various Factors caused the ETSSS burn rate to be significantly higher than the original estimates including maturation of the Integrated Testing Program along with five additional EHR deployments. Factors include increased intellectual property testing, system interfaces and their functional and regression testing, significant increases in sustainment testing workload, and support of over 150 rapid enterprise baseline improvements build/configurations enhancements with testing for the EHR reset activities. To meet the VA-specific requirements within the commercial EHR, an unanticipated number (30+) Oracle Health (the prime contractor for the EHRM contract) intellectual property (development) projects, assessment and evaluation projects were awarded. These projects have complex testing requirements for the new features/functions as well as retesting existing capabilities to ensure the change does not break existing functionality. The first EHRM capability set contained 73 interfaces, the actual number of system interfaces since then has more than doubled and is now 163 as new site assessments were executed and interface requirements identified. The workload for interface regression and extended functional testing of interfaces increased well over the original estimates given that the larger system interfaces number and the experience gained within the program of the complexity of integrating a commercial EHR system with the large volume of legacy systems and the downstream functionality that uses the interface data.

Additionally, the sustainment testing requirement to test both the twice a year code upgrades and the large volume of monthly package updates for break/fix items was substantially higher than anticipated.

Additionally, VA has faced unanticipated delays with the competitive contract. Delays to the competitive acquisition were incurred by changing requirements during the 3rd Quarter of FY24 related to EHRM that affected the scope of the competitive IETSS contract. Specifically, VA had to ensure that EHRM testing requirements were captured correctly under the new competitive IETSS contract and not in conflict with Congressional interest in Independent Validation and Verification of the EHRM program.

4. Statutory Authority: This acquisition will be conducted under the authority of the Multiple- Award Schedule Program. The specific authority providing for a limited source award is Federal Acquisition Regulation (FAR) 8.405-6(a)(1)(i)(B), “Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized.”

5. Rationale Supporting Use of Authority Cited Above: The proposed source is PSI, located at 10632 Little Patuxent Parkway, Suite 200, Columbia, Maryland 21044-6250. PSI is the only capable source to ensure continuity of these complex services, considering the critical need for Block 12 Code Upgrade deployment, sustainment testing in support of daily production operations and testing support EHRM reset workstreams such as Effective Configuration Processes. PSI resources provides testing services and test environment services are fully integrated into teams across EHRM-IO, OIT, OFC, and Oracle Health pillars. PSI testing services are integrated into EHRM-IO Oracle development projects such as the pharmacy enhancements project that delivers critical outpatient improvements to be implemented with Block 12 code upgrade. PSI system interface testers and test systems engineering resources are tightly integrated into the System Integration teams across EHRM-IO, OIT, Office of Functional Champion, and Oracle Health pillars. PSI project management resources are integrated into the EHRM-IO program control creation and maintenance of the Integrated Master Schedule.

An alternate contractor would need to fully understand the Oracle Millennium-to-VistA architecture required for test environments, including all related systems such as the Master Patient Index (MPI), the Veterans Data Integration and Federation Enterprise Platform (VDIF EP), and all 120+ Oracle health solution areas currently in use.

The bulk of testing services that PSI is providing will (1) support Block 12 code upgrade deployment. Block 12 code upgrade testing is intensive, complex, and covers new system integrations, workflows, intellectual property projects (Oracle solutions development for pharmacy) and (2) the testing services required for sustainment of daily operations testing such as the monthly break/fix package releases, testing of 3rd party system integrations upgrades, and complex build/configuration updates.

EHRM-IO and OIT require a continuity of these complex testing services to meet the critical Block 12 code upgrade schedule, the EHRM reset activities with testing requirements, and the testing needs of the daily production operations. This ceiling increase will enable VA to retain the testing services and expertise provided by PSI while the recompete is concurrently underway.

Delays in testing code slated for the February 2025 Block 12 release would delay critical functional improvements benefiting clinicians, patient care and benefit processing including:

Three-Dimensional (3D) technology to help Practitioners capture images and automate wound analysis and measurement tasks which eliminates manual processes currently in place.

Standardized compounding processes of IV medication such as order review, medication picking and dose preparation to improve medication safety the pharmacy workflow.

Impacted sites may also have issues with drug safety related to IV dispensing and cause low efficiency due to wastage in human compounding.

Improved copayment automation to eliminate potential Veteran overcharges.

Creating, editing, renewing mental health patient intakes and treatment plans, and enabling care teams to collaborate to ensure provider compliance with regulatory guidelines.

Streamlined patient refunds and reduced manual processes and bank fees related to refund issuance.

Automatic compiling and management of patients’ cardiac device data to reduce manual process and potential errors during upload of physician/therapist notes.

Automated integration of capsule endoscopy results into Millennium thereby reducing extensive manual processes currently in place.

Reduced manual processing related to community care referrals and authorizations.

In addition to the critical Block 12 testing system integration, clinical functionality, and pharmacy enhancements described above, the testing of approved workflows and processes has become more complex than originally anticipated due to the large number of workflows associated with the EHRM solution, and the effort involved in obtaining clinical and functional consensus on VA enterprise-wide workflow configurations. VA SMEs have identified that the nature of testing Clinical software applications operating in existing VA Medical Centers delivering healthcare to Veterans and beneficiaries, is of a complex and critical nature involving Clinical encounter workflow functional testing (workflows – primary care, labs, pharmaceuticals, specialty care (oncology and cardiology), administrative, financial, and other process workflows). Each workflow requires the testing team to develop a Criticality Analysis and Risk Assessment (CARA) execution. The EHRM-IO-specific knowledge gained by PSI to date from their integration into the workshops/workflow processes is essential to the CARA analysis of the approved workflows. The program is coming out of a pause/reset where improved system functionality and workflows have been proposed to improve user adoption. Therefore, a significant number of workflow changes are planned for the first quarter of FY 2025. CARA services are highly specialized and define the scope of workflows to be formally tested.

Continued PSI presence during this process is critical since workflow reviews and approvals remain for analysis, approval, and CARA execution in early FY 2025. Each workflow requires CARA services expertise to determine the risk-based evaluation scope. PSI has established an in-depth knowledge of the approved workflows which will streamline testing on the pending work resulting from the program reset. The Workflow Risk Assessment/CARA activity being completed is a predecessor that must conclude before any test cases can be written and executed.

Transitioning another vendor into the complexities of Block 12 code upgrades, EHRM workflows, and the supporting CARA processes across every clinical function comprising the

EHRM solution is not feasible in the timeframe required to support the upcoming resumption of site deployments anticipated in FY 2025.

Any source other than PSI must complete testing, validation, and review of the items in the testing pipeline on the applicable test platform with the applicable test tools. There are over 200 process and 150 system integrations that are involved to provide IETSS Services. Based on historical data from similar previous efforts, VA anticipates that this transition process will take at least five months to complete. Approximately 165 Full Time Equivalent (FTE) contractor staff support the current effort. The transition of the process, platform, test tools and functional knowledge from the current 165 test personnel to a new set of test personnel is a significant and time-consuming task.

Bringing on a new vendor as VA approaches the crucial Block 12 deployment would introduce an unmitigable amount of risk to the EHRM schedule and program due to the transition time required to remedy a new vendor’s lack of expertise in ongoing Block 12 testing as well as the VA-specific test platforms, processes and tools. A significant transition time of approximately five or more months is needed to achieve full operating capability considering there are over 217 Enterprise Testing Services processes required for a new contractor to obtain the necessary expertise. This also includes knowledge transition for approximately 150 system integrations, which are in-scope for post go-live sustainment testing support for live production sites at VA medical centers supporting critical patient care. The system integration work includes analysis of all Interface Control Documents to identify test environment requirements, gap analysis of test environment requirements, and creation of test harnesses/virtualized services to address the gaps. Additionally, a minimum of 30 days is required for background check, on-boarding, providing Government Furnished Equipment, PIV card issuance, VA network access, and user provisioning for access to the EHRM system and testing tools. The combined on-boarding and education/transition timeframe is estimated at 6 or more months.

Therefore, if the ceiling is not increased, and a new contract for the Block 12 work is awarded when the current contract lapses in September 2024, a new contractor would not be capable of initiating full-scale testing support until June 2025 – long after the critical Block 12 release date in February. Spending roughly 6 months to transition a new vendor to start up to 5 months of work after onboarding activities are completed is not a realistic approach for two equally compelling reasons. The transition period would not be completed in time to avoid a lapse in service. And an expensive and time-consuming 6-month transition to initiate 5 months of testing work cannot be easily justified.

PSI is the only vendor with the Block 12 code upgrade expertise, CARA expertise, the insight into EHRM workflows, the knowledge to support system integration testing with VistA legacy components and third-party systems required to support the upcoming deployments, block upgrades, and daily operations. PSI has processes, environments and teams in place with the necessary expertise to perform and complete the required formal testing on schedule. The test systems engineering services for systems integration require highly specialized knowledge of both the EHRM solution domains and existing VA legacy system domains. There is no time in the schedule for Block 12 and ongoing sustainment releases to accommodate transition to a new test support vendor.

Based on the information presented above, PSI is the only source that can meet the current Block 12 and ongoing sustainment requirements. PSI is the only vendor who can provide the required testing services, without adversely impacting EHRM implementation deadlines. PSI has resources with the required skillsets in teams organized to meet mission requirements already in place, can ensure continuity, and can provide services required for EHRM implementation deadlines to be met.

This ceiling increase effort is being done concurrently with the long-term competitive effort outlined in Efforts to Obtain Competition section so that any potential transition can take place without negatively impacting the EHRM schedule. The delay of the recompete, the increased burn rate over the original estimate, and the complexity of transition combine to require this increase to the ceiling while the recompete is underway.

Failure to continue testing efforts with an increased ceiling and PoP will create a lapse in critical test support services. Recent Congressional hearings have highlighted the critical need for the pharmacy code upgrade included in Block 12 to seamlessly integrate outpatient prescription processing between providers and pharmacists. Delay of just this one of the Block 12 code upgrades results in continued manual processing and potential errors in providing outpatient medications to Veterans with a direct impact to Veteran care and safety. Failure to provide production-ready code for the Block 12 upgrade release, and delay in support of ongoing sustainment testing requirements will negatively impact the timeline and improved health care capabilities provided through modernization of VA health record systems supporting the Veteran.

6. Efforts to Obtain Competition: While the VA testing support team confirms that many companies are likely capable of providing test support, none can ramp up to continue the critical ongoing test services required without a significant lapse in service. It is determined that PSI is the only source capable of meeting VA’s requirements. There is no competition anticipated for this modification. In accordance with FAR 5.301 and 8.405-6(a)(2), the award notice for this action will be synopsized on the Contracting Opportunities website and this justification will be made publicly available within 14 days of award.

7. Actions to Increase Competition: No barriers to future competition are anticipated. EHRM-IO and OIT are working a full ETSSS recompete named Independent Enterprise Testing Services (IETSS) simultaneously with this follow-on action. VA anticipates issuing a competitive solicitation for the IETSS recompete, which is scheduled to be released on or about October 2024. VA is anticipating an award of the competitive acquisition in December 2024. This will allow a smooth transition to onboard and methodically subsume all the future ETS testing activities which will occur after Block 12 code upgrade release if a vendor other than PSI is awarded the competitive effort.

8. Market Research: Throughout FY24, the VA OIT and EHRM Software Testing SMEs surveyed the marketplace for testing capabilities in support of upcoming follow-on testing requirements. While the VA OIT and EHRM software testing support team confirms that other companies are likely capable of providing general testing support, none can ramp up to continue the critical ongoing test services required without a significant lapse in service. VA government software testing subject matter experts (SMEs) maintain knowledge of testing industry capabilities and processes applicable in meeting VA testing requirements. Based on the rationale identified in section 5 of this document, no other source can meet the VAs requirements in the time frame required.

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. Determination of Best Value: I hereby determine that the proposed contract action will represent the best value to the Government consistent with FAR 8.404(d). GSA has already determined that the prices on the GSA FSS contract are fair and reasonable. Further price analysis, to include an analysis of proposed level of effort and mix of labor, will be conducted and subsequent negotiations held as necessary.

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

13. Office of General Counsel (OGC) Review: I have reviewed this document and find it legally sufficient, based on the representations set forth in the documents and, if any, attachments.

The Advocate for Competition’s approval is an independently supported decision not wholly reliant on the legal sufficiency determination.

Approval

In my role as procuring activity Advocate for Competition, based on the foregoing justification, I hereby approve the Enterprise Testing Service Support Services additional work modification, on another than fair opportunity basis pursuant to the authority cited in paragraph 4 above, subject to availability of funds, and provided that the services herein described have otherwise been authorized for acquisition.