36C10B19C0034-002.pdf

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 sole source, firm-fixed price (FFP) Contract for the delivery of a Radiotherapy Incident Reporting and Analysis System (RIRAS) license.

3. Description of the Supplies or Services: The Under Secretary for Health (USH), through the National Radiation Safety Committee, requires the VA National Radiation Oncology Program (NROP) office in cooperation with the National Health Physics Program (NHPP) to establish a program to electronically collect clinical radiotherapy adverse events and "good catch" (near miss) event data for approximately 15,000 Veterans treated with radiotherapy annually at 40 VHA facilities that offer radiation oncology services. The Radiotherapy Incident Reporting and Analysis System software has the capability to meet these requirements. The deployment of RIRAS will enhance the quality and safety of radiotherapy delivered to veterans at VHA facilities.

In this USH mandated reporting process the web based RIRAS medical software encompasses the entire feedback loop by reporting an incident, analyzing the event for root cause, and developing interventions to prevent recurrence. The RIRAS software includes tools to perform analysis of radiotherapy incidents and good catches and has the ability to define corrective actions and provide policy guidance to the radiation oncology community in the VA. 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 Radiotherapy Incident Reporting and Analysis System should have the following functionalities:

1. Enables reporting of incidents by users at radiation oncology facilities or from any anonymous reporters.

2. Enable NHPP and NROP staff to analyze reported incidents.

3. Create summary of incident reports

4. Create patient safety work products.

5. Maintains database of incidents with search and retrieve capabilities.

6. Displays statistics of reported incidents graphically

7. Ensures privacy of patients and event reporter information.

The RIRAS medical software shall use dataset radiotherapy specific medical taxonomies and data dictionaries defined in AAPM and ASTRO reports on error reporting. The peer review publication on these taxonomies can be found at https://www.ncbi.nlm.nih.gov/pubmed/23231278. The RIRAS software will record clinical, https://www.ncbi.nlm.nih.gov/pubmed/23231278

Radiotherapy Incident Reporting and Analysis System (RIRAS) Software License TAC Number: TAC-55566 event-based data and clinicians will be able to derive clinical best practices and practice improvements.

The RIRAS software shall have 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.

The RIRAS software shall have features that encompass 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. The RIRAS software shall have features to view national level trends that can be viewed by the senior leaders. The RIRAS software shall suggest process improvements.

The RIRAS software shall have tools to record 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.

The software aggregates data for:

• All radiotherapy errors regardless of whether they lead to harm (good catch)

• All radiotherapy specific adverse events that are recordable at facility level

• Medical radiotherapy events that are reportable (regulatory requirement)

• Issues/problems with all radiotherapy devices

Key attributes of the software are

• Medical Radiotherapy based Taxonomy and data dictionary based on American Association of Physicist in Medicine (AAPM) document on, “Error Reporting”,

• A carefully designed data entry form that minimizes keystrokes (pull-down menus based on well-established clinical workflow for consistent data reporting, pre-filled facility data, etc.), These forms are specifically designed for radiotherapy incident reporting workflow.

• Enables reporting of incidents by users at radiation oncology facilities or from any anonymous reporters.

Enable NHPP and NROP staff to

• Analyze reported incidents.

• Create summary of incident reports

• Create patient safety work products.

• Maintains database of incidents with search and retrieve capabilities.

• Displays statistics of reported incidents graphically

• Ensures privacy of patients and event reporter information.

• Includes reporting of issues / problems with all radiotherapy devices used enterprise wide.

• Utilities that provide a corrective action for each adverse event reported.

• Feedback to provider include

• recommendations for mitigating future errors,

• protocols for safe operation

• Information regarding best practices.

Based on the workflow of the RIRAS software the following events can be found.

• Inconsistent patient setup instructions/documentation

• Nonadherence to policies and procedures

• Lax “time out” policies

• Distracted RTTs at the treatment console

• Lack of “sterile cockpit” environment

• Poor communication between team members

• Inadequate RTT staffing for patient setup and delivery

• Majority of the mis-administrations were attributed to wrong shifts, which resulted in wrong treatment site

• We found that it was often necessary to follow-up with the facility to gather more complete information regarding the incident to perform a complete root cause analysis and to develop a corrective action plan.

The design of this system must use dataset taxonomies and data dictionaries defined in AAPM and ASTRO reports on error reporting. The period of performance is 12 months with three (3) 12-month option periods.

4. Statutory Authority: FAR 13.106-1(b)(1) For purchases not exceeding the simplified acquisition threshold, contracting officers may solicit from one source if the contracting officer determines that the circumstances of the contract action deem only one source reasonably available.

5. Rationale Supporting Use of Authority Cited Above: The proposed source for this action TSG Innovations (TSG), 320 Salsbury Drive, Santa Clara, CA 95051. Market research indicates there is no other IT solution in place in the marketplace with the software to record radiation oncology-based incidents and encompasses the entire feedback loop by reporting an incident, analyzing the event for root cause, and developing interventions to prevent recurrence. The RIRAS software includes tools to perform analysis of radiotherapy incidents and good catches and has the ability to define corrective actions and provide policy guidance to the radiation oncology community in the VA. The RIRAS will be an intranet-based radiation oncology-based incident reporting system accessible to all VA Radiation Oncology clinics. It will enable VHA radiation oncology staff to record and subject matter experts such as physicians and physicists to analyze incidents. This software solution will have no dependencies on or interfaces with other VA systems. The solution will only require VA intranet storage and application capability hardware. The contracting vehicle in place for this effort did not include the purchase of source code data. Not only is TSG the sole developer of the RIRAS product, but it has no authorized resellers and it does not subcontract out any of the required work. Based on the above, TSG 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 did not yield any additional sources that can meet the Government’s requirements; therefore, no competition is anticipated for this acquisition. In accordance with 16.505(b)(2)(ii)(D), this action will not be synopsized and the justification will not be made publicly available within the Federal Business Opportunities Page because the total estimated price is less than the simplified acquisition threshold, but the Justification will be posted on the Federal Business Opportunities Page to notify all interested parties 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 market place that would enable future actions to be competed.

8. Market Research: Market research was conducted by the Government’s technical experts through December 2018 surveyed industry by reviewing the capabilities of the Radiation Oncology vendors such as the Varian Medical Systems, Elekta Oncology Systems, and Accuray, Inc. and determined none had any reporting software that are required to meet the requirements. Further, Joint Patient Safety Reporting System (JPSR) and Patient safety assessment tool (PSAT) (http://vaww.ncps.med.va.gov/Tools/PSAT/index.html) were evaluated and did not meet the requirements for a radiotherapy specific reporting and analysis tool. The data elements and workflow of the above-mentioned tools were not fit for analysis of events

Radiotherapy Incident Reporting and Analysis System (RIRAS) Software License, TAC- 19-55566 from the radiation oncology clinics. Both the above-mentioned tools did not have the data elements and workflow that is needed for radiation oncology incident reporting.

They did not have tools to rate the severity of events based on dosimetry, 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 would like to analyze.

In April 2019, the Contract Specialist contacted TSG to determine whether TSG was the sole owner of the Source Code and if it had any authorized resellers. On April 19, 2019, TSG provided an email confirming that TSG owns the source code, has no plans to sell their source code to anyone, and does not have any authorized resellers. As a result, the market research confirmed that TSG is the only service provider capable of meeting the Government’s requirements for this effort.

9. Other Facts: None.