P03 - JA for Dialysis EHR Software Solution - Redacted.pdf

FORCE Number VA-22-00042797

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: The proposed action is for a sole source, firm-fixed price Indefinite Delivery, Indefinite Quantity (IDIQ) contract with five 12-month ordering periods (60 months) to be issued on Contract Opportunities (open market) for brand name cyberREN Dialysis Electronic Health Record (EHR) Software Solution, to Document Storage Systems, Inc. (DSS), 12575 U.S. Highway 1, Suite 200, Juno Beach, FL 33408. The IDIQ’s period of performance will be August 28, 2022, through August 27, 2027.

3. Description of Supplies or Services: The proposed action is to ensure cyberREN availability for the 106 VA facilities enterprise-wide that perform dialysis. VA requires a dialysis EHR software solution that has an existing hemodialysis interface with VA’s current EHR (Veterans Health Information Systems and Technology Architecture (VistA)/Computerized Patient Record System (CPRS)) and is capable of interfacing with VA’s future EHR (Cerner). The brand name cyberREN dialysis EHR software solution includes the Cybernius Medical Ltd, original equipment manufacturer (OEM) cyberREN dialysis perpetual software, the proprietary Kernel Installation and Distribution System (KIDS) that enables integration of cyberREN with VA’s current and future EHR, associated servers, installation, implementation training, maintenance, technical support and program management.

The proposed action will provide maintenance, updates and upgrades to the perpetual software licenses VA has already purchased at the 46 VA dialysis centers that are currently using cyberREN. Maintenance and technical support for these centers also includes telephone and online support and technical consultation, scheduled and unscheduled maintenance.

Additionally, this action is for the 60 dialysis centers that have not yet purchased cyberREN to have the ability to purchase the cyberREN solution and associated installation and testing, training, maintenance and technical support as appropriate during the period of performance. Furthermore, this action will allow dialysis centers to implement the cyberREN solution in the VA Enterprise Cloud, provide enterprise-wide program management and provide support to achieve and maintain the authority to operate. Lastly, frequent changes to the dialysis EHR solution increase risk of disruption to patient care; this action will directly reduce the risk of disruption by providing a standardized ordering method over the life of the contract.

The maximum total value of the proposed action is $26,501,043.47 (inclusive of five 12-month ordering periods).

National Dialysis EHR Software Solution FORCE Number VA-22-00042797

It is estimated that a 60-month (5 year) ordering period is required to fully implement the dialysis EHR throughout the remaining 60 dialysis centers across the United States. This estimated timeframe is based on the time that was required to fully implement the cyberREN Dialysis EHR Software Solution to the initial 46 dialysis centers.

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 entitled, “Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements.”

5. Rationale Supporting Use of Authority Cited Above: VA has been deploying the cyberREN dialysis EHR software across the enterprise since 2017 with the intent of having a consistent and interoperable EHR solution across the 106 VA dialysis centers that enables standardized documentation of dialysis care as required by the Centers for Medicare and Medicaid mandated web-based dialysis quality collection system Endstage Renal Disease Quality Reporting System (formerly CROWNWeb, Consolidated Renal Operations in a Web-Enabled Network) and Veterans Health Administration Handbook 1042.01, Criteria and Standards for VA Dialysis Programs, and Title 42 Code of Federal Regulations Part 494, Conditions of Coverage for End Stage Renal Disease Facilities, Condition 110, Quality Assessment and Performance Improvement. A single, dialysis EHR solution is critical to VA’s ability to deliver optimal dialysis care and to assess the quality and safety of that dialysis care enterprise-wide, which would not be possible if disparate dialysis EHR solutions were utilized.

While multiple dialysis EHR solutions are commercially available, no alternative solution has an existing functional interface with VA’s EHR enterprise-wide or can meet VA’s need for a single dialysis EHR solution. Specifically, the cyberREN EHR software solution includes a proprietary Integration Framework that enables communication with the VistA/CPRS. The interface between the cyberREN software solution and the VistA/CPRS has been built and optimized over the past five years as a result of on-going engagement between VA subject matter experts (nephrologists, dialysis nurse manager, Office of Information and Technology, pharmacy and laboratory) and DSS. The original deployment of this solution at each of the 46 centers required a team of seven site-specific medical and technical experts as well as a four-person national team over the past five years to establish and optimize the interface between cyberREN and VistA/CPRS, define the dialysis center’s data capture requirements and workflow processes (such as clinic naming structures, hemodialysis flowsheets, medication ordering procedures, etc.), and validate the functionality of the interface. In addition, these teams established enterprise-wide standard business rules for capture, reporting, calculation and transmission of critical data points between cyberREN and VistA/CPRS. These processes were required to be replicated at each of the 46 dialysis centers due to the uniqueness of each dialysis center. Due to proprietary constraints of the cyberREN dialysis EHR software and the developed interfaces, use of any alternative dialysis software solution would necessitate a complete replacement of the existing infrastructure. Specifically, the use of any alternative dialysis software solution would require the redevelopment of interfaces with VistA/CPRS at the existing 46 dialysis centers and redevelopment of an enterprise-wide standard business rule for capture, reporting, calculation and transmission of critical data points between cyberREN and any alternative software. Based on previous acquisition history, this redevelopment and redeployment effort is estimated to cost a minimum of approximately $4.3 million and take approximately five years to accomplish. Additionally, use of any other solution would require the replacement of the 46 cyberREN Dialysis EHR perpetual software site licenses VA had previously procured for the 46 existing sites. Based on previous acquisition history, these additional duplicated costs are approximately $9.2 million. These estimated duplicative costs of approximately $13.5 million would not be recovered through competition. Further, any change would delay or potentially prevent VA from achieving its requirement for an enterprise-wide solution which is deployed at all 106 dialysis centers.

Failure to maintain the cyberREN Dialysis EHR solution would cause serious harm to Veterans Health Administration and thousands of patients at the 46 dialysis centers nationwide in which the cyberREN solution has already been deployed.

These 46 dialysis centers would experience a significant disruption in delivery of Veteran dialysis care as critical, automated workflows enabled by the current cyberREN solution (such as medication and laboratory ordering, hemodialysis flowsheet generation, communication with VistA/CPRS and generation of patient safety alerts) would cease. Nursing staff would be required to revert to antiquated manual documentation of all the parameters of dialysis treatments, significantly reducing VA’s capacity for delivering dialysis due to the inefficient use of its scarce dialysis nurse workforce and rendering VA vulnerable to adverse medical-legal action related to documentation errors and omissions. Failure to maintain the cyberREN EHR solution would drastically impact the delivery of life-saving dialysis treatment to Veterans and would present unacceptable risks to the thousands of dialysis patients at these 46 dialysis centers.

Additionally, for the 60 dialysis centers without a dialysis EHR solution, failure to provide the cyberREN solution would continue the inefficient practice of manual transcription and scanning patient care records into VistA/CPRS. Manual transcription and scanning of records are suboptimal as it is highly vulnerable to errors and prohibits use of the data for quality improvement. Transitioning medical record documentation from the current manual process to automated electronic capture via the dialysis EHR would result in significant efficiencies to VA. The current practice of manual entry equates to approximately one full-time equivalent per year per center. This cost is estimated at $10.8 million annually that would be redirected toward patient care activities for 60 centers once manual documentation is discontinued.

As detailed above, no other brand name software can meet the Government’s requirement for an existing functional interface with VA’s EHR enterprise-wide as provided by the proprietary KIDS Integration Framework that enables integration of cyberREN with VA’s EHR (VistA/CPRS). Additionally, through market research, as described in section 8 of this document, no other known brand name software can meet the Government’s requirement for continued use of the cyberREN EHR software solution at the 46 VA dialysis centers currently using the software as they do not have access to the proprietary source code necessary to provide software maintenance and support and would not be able to provide periodic upgrades and security updates as is standard for all software solutions.

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. In accordance with FAR 6.302- 1(c)(1)(ii)(c) and 5.102(a)(6) this justification shall be posted with the solicitation.

Furthermore, 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.

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 February and March 2022 by reviewing similar products to ascertain if other brands could meet VA’s functional and technical requirements. Specifically, the Government’s technical experts performed web-based market research and reviewed similar dialysis EHR software solution platforms, such as those available from Constellation Kidney Group, Gaia and Renesan. The Government’s technical experts concluded that no other solutions could meet VA’s requirements as they are not interoperable with the existing cyberREN deployment or have an existing, functional capability to interoperate with VA’s EHR at the enterprise level.

Additionally, no other alternative solution can avoid the duplication of cost and time as outlined in Section 5 of this justification.

In February 2022, the Contract Specialist (CS) conducted additional market research by sending an email to the OEM Cybernius Medical Ltd in Canada requesting any authorized resellers in the United States. The OEM responded on February 28, 2022, with an authorized reseller letter identifying DSS as the sole reseller/distributor of the cyberREN product for the VA in the United States, stating that no other company, other than DSS is licensed to sell the cyberREN product. The OEM advised that only DSS has the right or ability to deliver the cyberREN Dialysis EHR software solution to the VA.

Additionally, in March 2022, the CS posted a Request for Information (RFI) on Contract Opportunities formerly known as Federal Business Opportunities website.

The RFI requested vendors describe their dialysis EHR software, ability to meet

VA’s dialysis EHR technical requirements, compatibility of their dialysis software with VA infrastructure and approach to meeting VA’s requirements. The RFI resulted in one response from DSS on April 5, 2022, which proposed cyberREN dialysis EHR software. The Government’s technical experts reviewed the one response received from DSS and found DSS capable of meeting the Government’s requirements. No additional responses or alternative solutions were proposed. In its RFI response, DSS identified that cyberREN could be procured through a General Services Administration (GSA) Schedule or an authorized reseller on National Aeronautics and Space Administration (NASA) Solutions for Enterprise-Wide Procurement (SEWP) V Government-Wide Acquisition Contract, Minburn Technology Group, L.L.C (Minburn). However, because GSA and NASA SEWP are not viable acquisition sources for this effort, the CS e-mailed DSS on April 11, 2022, asking for an explanation as to how DSS could be the sole provider of cyberREN and have a reseller on NASA SEWP. DSS confirmed that Minburn is an authorized reseller on NASA SEWP and after additional communications confirmed that in an open market scenario, DSS is the only company that would respond with the CyberREN solution.

Therefore, at present, there is no other solution available in the marketplace that can meet this requirement or avoid the duplicative costs and time to redevelop the required interfaces to VistA/CPRS as detailed in section 5 of this justification. It has been determined that only the cyberREN dialysis EHR software solution can meet VA’s needs, including the need for a single, dialysis EHR solution.

Based on this market research, the Government does not expect to receive two or more offers from multiple Service-Disabled Veteran-Owned Small Business (SDVOSBs) or Veteran-Owned Small Businesses (VOSBs) or any other socio-economic groups; therefore, this action cannot be set-aside. The Government has determined that this acquisition shall be solicited open market on a sole source basis.

9. Other Facts: None.

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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.

Katherine Murphy Date: 7/20/2022

Murphy, Katherine

Digitally signed by Murphy, Katherine E.

Program Manager Signature: E. Date: 2022.07.20 15:16:15 -04'00'

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 historical pricing, competitive published price lists and the Independent Government Cost Estimate for the required sole source cyberREN Dialysis EHR Software Solution described herein. Price analysis may be performed in accordance with FAR 15.404-1(b)(2)(ii), (iv), and (v) respectively.

Lori L. Walker Date: 7/20/2022 Digitally signed by Lori L. Walker

Procuring Contracting Officer Signature: Lori L. Walker Date: 2022.07.20 14:31:04

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

Lori L. Walker Date: 7/20/2022

Digitally signed by Lori L. Walker

Procuring Contracting Officer Signature: Lori L. Walker Date: 2022.07.20 14:31:26

Approval

In my role as Head of the Contracting Activity, based on the foregoing justification, I hereby approve the acquisition of cyberREN dialysis EHR software solution, 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 property and services herein described have otherwise been authorized for acquisition.

Date: Signature:

MICHELE FOSTER

Michele R. Foster

Digitally signed by MICHELE

FOSTER

Date: 2022.07.22 14:45:41 -04'00'

Head of the Contracting Activity Technology Acquisition Center Office of Procurement, Acquisition, and Logistics