RIRAS JA.pdf

VA-24-00052409

JUSTIFICATION FOR A SOLE SOURCE AWARD

FOR CERTAIN COMMERCIAL ITEMS

1. Contracting Activity: Department of Veterans Affairs

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 contract for the delivery of a Radiotherapy Incident Reporting and Analysis System (RIRAS) license with associated maintenance and support with Intelligent Health Solutions, LLC, 12701 Parchment Lane, Henrico, VA 23233.

3. Description of Supplies or Services: The Under Secretary for Health, through the National Radiation Safety Committee, requires the VA National Radiation Oncology Program office, in cooperation with the National Health Physics Program, RIRAS software license with maintenance and support. RIRAS was established in 2019 and has the capability to electronically collect clinical radiotherapy adverse events and good catch (near miss) event data for approximately 15,000 Veterans treated with radiotherapy annual at 41 Veterans Health Administration (VHA) facilities that offer radiation oncology series. The RIRAS medical software encompasses the entire feedback loop by reporting an incident, analyzing the event for root causes and developing interventions to prevent a recurrence. This medical event reporting software performs analysis of radiotherapy incident and good catches and defines corrective actions and policy guidance for the field and the relevant and Radiation Oncology. The analysis reports with corrective, learning actions should be shareable with the reporter/facility and made public to the community (after de-identification) as part of the learning process.

The RIRAS software has the workflow to analyze the radiotherapy reported incidents, identify vulnerabilities of clinical processes, provide tools to identify system wide vulnerabilities and suggest substantial improvements in radiation oncology clinical workflow. It encompasses the entire feedback loop of reporting an incident, analyzing it for salient details, and developing interventions for the clinicians and technical medical staff to prevent these events from happening again. Additionally, it provides national level trends that can be viewed by the senior leaders and also suggest process improvements.

The RIRAS software records analysis reports from subject matter experts (consists of Radiation Oncologists/Physicians, Therapeutic Medical Physicists, Dosimetrists and therapy team members) with sections on corrective, learning and preventative actions which should be shared with the reporters/facility and deidentified data are made public to the radiotherapy and medical community as part of the learning process.

VA requires the RIRAS Enterprise software license with associated maintenance and support as well as additional training and remote service support as optional tasks for each period. This license shall include unlimited number of clients to access the website and unlimited number of facility licenses to use the software within the VA intranet.

Radiotherapy Incident and Analysis System (RIRAS) Software License

The period of performance is 12 months with three 12-month option periods and optional tasks for additional training and remote support. The total estimated value for this action is

4. Statutory Authority: The Statutory authority permitting an exception to fair opportunity is Section 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: The proposed source for this action is Intelligent Health Solutions (IHS), LLC, 12701 Parchment Lane, Henrico, VA 23233. Market research indicates no other IT solution exists in the marketplace with the software to record radiation oncology-based incidents that meets all of VA’s requirements. RIRAS software encompasses the entire feedback loop by reporting an incident, analyzing the event for root causes, and developing interventions to prevent a recurrence. The RIRAS software includes tools to perform analysis of radiotherapy incidents and good catches. It can define corrective actions and provide policy guidance to the radiation oncology community in the VA. The RIRAS is an intranet-based radiation oncology-based incident reporting system accessible to all VA Radiation Oncology clinics. It enables VHA radiation oncology staff to record, and subject matter experts such as physicians and physicists to analyze incidents. This software solution does not depend on, or interface with other VA systems, and only requires VA intranet storage and application capability hardware. The contracting vehicle for this effort did not include the purchase of source code data. RIRAS software program and all rights associated is managed and owned by IHS and has no authorized resellers and does not subcontract any of the required work. Based on the above, IHS is the sole contractor capable of meeting this requirement.

6. Efforts to Obtain Competition: Market research was conducted, the details of which are in section 8 of this justification. This effort yielded no additional sources to meet the Government's requirements; therefore, no competition is anticipated for this acquisition.

7. Actions to Increase Competition: The Government will continue to conduct market research to ascertain if there are changes in the marketplace that will enable future actions to be completed.

8. Market Research: In accordance with VA Acquisition Regulation 810.001-70, market research was conducted via the Small Business Administration (SBA) Veteran Small Business Certification (VetCert) database at https://veterans.certify.sba.gov. The SBA VetCert database was screened for a list of all Service-Disabled Veteran-Owned Small Businesses (SDVOSBs) and Veteran-Owned Small Businesses (VOSBs) under the North American Industry Classification System (NAICS) code 513210, “Software Publishers.” The results of the search found a total of 198 SDVOSBs and VOSBs under the NAICS code 513210. The VetCert results were placed in the contract file. Despite

Radiotherapy Incident and Analysis System (RIRAS) Software License the number of matches, the requirement discussed herein is more specialized than a simple NAICS code search. Therefore, more specific market research was necessary.

The result of this market research (discussed below) was the primary market research considered for this procurement.

Market research was conducted by the Government's technical experts through March 2024. This included a survey of the industry by reviewing the capabilities of the Radiation Oncology vendors, Varian Medical Systems, Elekta Oncology Systems, and Accuray, Inc., and it was determined that none had any reporting software capable of meeting the requirements. Furthermore, existing systems were evaluated. Specifically, the program office looked at Department of Defense’s Joint Patient Safety Reporting System (JPSR) and VHA’s Patient safety assessment tool (PSAT) (http://vaww.ncps.med.va.gov/Tools/PSAT/index.html) and determined that these systems did not meet the requirements for radiotherapy-specific reporting and analysis. The data elements and workflow of the tools mentioned above were not fit for analysis of events from the radiation oncology clinics. Both tools discussed above needed the data elements and workflow required for radiation oncology incident reporting. They did not have the means to rate the severity of events based on dosimetry or medical severity scales. These systems were not able to present the collated data in a format that the national radiation safety committee and senior leadership is required to analyze.

Additionally, in May 2024, a Request for Information was issued on Contract Opportunities to see if any other vendors were capable of meeting the Government’s requirements. One response was received by IHS, which was reviewed and deemed technically capable by the Government’s technical expert. As a result, the market research confirmed that IHS is the only service provider capable of meeting the Government's requirements for this effort. No alternative software was proposed.

In January 2024, TSG Innovations, Inc. (TSG) contacted Intelligent Health Solutions LLC (IHS) via email to confirm discussions that the RIRAS Software Program would be managed and owned, along with all rights associated, by IHS. In March 2024, the Contract Specialist contacted IHS to determine whether IHS was the sole owner of the source code and if it had any authorized resellers. IHS provided an email confirming that TSG shall transfer ownership of the RIRAS Software Program, and all rights associated to IHS, to be managed and owned by IHS. IHS owns the source code, has no plans to sell it to anyone, and does not have authorized resellers.

9. Other Facts: None.