Support for Quality and Safety Initiatives of the National Radiation Oncology Program

THIS REQUEST FOR INFORMATION (RFI)/ SOURCES SOUGHT IS ISSUED SOLELY FOR INFORMATION AND PLANNING PURPOSES ONLY AND DOES NOT CONSTITUTE A SOLICITATION. NOTICE This RFI does not constitute a Request for Quotation (RFQ) or a promise to issue an RFQ in the future. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Responders are advised that the Government will not pay for any information or administrative costs incurred in response to this RFI. It is the responsibility of the responders to monitor this site for additional information pertaining to this requirement. Responses or questions concerning the composition and requirements to the RFI will not be returned. All capable contractors are welcome to respond to this notice and shall provide a brief capability statement that covers the information in the performance work statement. The Capability Statement shall be limited to 10 pages and no more than 5MB. The Government will not review any other information or attachments included, that are more than the 10-page limit. The Government will not review generic marketing materials that do not address the information contained herein or the attached documents. GENERAL Your response must address capabilities specific to the services required in the performance work statement and must include the following: Request Company information to include: Company Name SAM CAGE & Unique Entity ID under which the company is registered in Sam.gov and/or veterans.certify.sba.gov/ Company Address Point of contact name Telephone number Email address Socioeconomic data Company Business Size Status and representations of your business Pricing of your products/solution. Pricing may be used for the purpose of market research only. Names and types of current federal contracts and/or contract vehicles that can be utilized for the - scope of the requirements. This is not a request for quotes. Period of performance is for a one year base plus four one year option periods. The NAICS code is 561492 All interested parties shall respond no later than 2/15/2025 at 5:00PM EST. Submit responses to via email to Amy.Ritchey@va.gov. Telephone responses will not be accepted. STATEMENT OF WORK Support for Quality and Safety Initiatives of the National Radiation Oncology Program GENERAL INFORMATION 1.Title of Project: National Radiation Oncology Program Informatics Services 2.Scope of Work: This statement of work outlines the requirements and objectives for establishing a contract to support the National Radiation Oncology Program's (NROP) quality and safety initiatives that require clinical informatics infrastructure and subject matter expertise support. The NROP's mission is to enhance healthcare services for veterans undergoing radiation treatments by improving clinical documentation and data management. This contract aims to provide the necessary subject matter expert personnel and services to sustain and enhance the Health Information Gateway and Exchange (HINGE) platform used for clinical quality surveillance program, expand capabilities for community care dashboard program, provide radiotherapy incident reporting program and analysis services, manage Ongoing Professional Practice Evaluation (OPPE) data, and conduct retrospective clinical data extraction from clinical notes. Health Information Gateway (HINGE) Sustainment and Enhancement Services Contractor shall provide subject matter expert services to sustain the central intranet-based QA database with dashboard software and HINGE applications accessible at each VHA radiation oncology facility. The contractor will provide support for the data communication packages between the HINGE application and the central QA database housing the quality measure data. The contractor will support the locally deployed HINGE data communication modules that will interface with medical devices and IT applications in Fast Interoperability Healthcare Resource (FHIR) and Digital Imaging and Communication in Medicine (DICOM) protocols. The responsibilities for the contractor shall include the following: - Maintain the data structures that are based on disease site-specific data elements and templates within the HINGE application. - Collate data from various medical devices and IT applications, such as Treatment Management System, Treatment Planning System, and CPRS/VistA, based on the defined data structures. - Implement automatic abstraction of data elements from medical devices/IT applications in subsequent phases. - Perform data completeness and integrity checks within the HINGE application to ensure the accuracy and integrity of the collected data. - Submit aggregated data securely to the intranet-based quality assessment and reporting database. - Analyze aggregated quality metric data using the decision tree logic provided by the radiation oncology disease site expert clinicians. - Generate quality report cards for each radiation oncology service. - Develop individualized quality improvement plans based on the analysis results. The contractor will be responsible for implementing and maintaining disease site-specific data entry templates and decision tree logic in the HINGE application. The contractor will maintain the data dictionary with complete verbiage, permissible values, and range of values for each data element, grouped into logical sets of web-based forms. Data elements shall have values selected from a list of given set of descriptions provided in the data dictionary. The contractor will implement a coding scheme for coding values of data elements using international code schemas such as SNOMED, ICD, CTCAE, etc., and have these values available to be uploaded in the VA's Corporate Data Warehouse (CDW) database. We are also seeking professional health informatics, project management and customer support services for the HINGE platform. Based on the disease site-specific data elements and templates defined for the five disease sites, the contractor will configure, and deploy the HINGE software at pilot radiation oncology clinics within the first year of the contract period. Develop and test interfaces to automatically abstract data elements from medical devices/IT systems clinical databases. The contractor's personnel shall attend team meetings and meetings with internal and external partners as required by the National Director, NROP, or designee. It is critical for the contractor to have prior experience with interfacing with Radiation Oncology specific tools like Treatment Planning Systems (TPS) and Treatment Management Systems (TMS) using technologies including DICOM and FHIR. The contractor must have participated and experienced the Integrating the Healthcare Enterprise - Radiation Oncology testing events for validating their products for interoperability with clinically deployed TPS and TMS. The contractor must have experience working with the VA's Personal Identity Verification (PIV) and Identity and Access Management (IAM) systems for software authentication. The contractor must demonstrate experience working with VistA and Oracle Cerner Electronic Health Record systems with developing HL7 v2.0 and FHIR interfaces with HINGE software systems. The contractor will provide subject matter experts to support the VA's Authority to Operate (ATO) process, including assisting in the creation of required documentations, vulnerability analysis and mitigation, as well as working with various security resources to sustain the cybersecurity process. In addition, the contractor will provide continued support for troubleshooting issues with deployment and ensuring reliability of the HINGE platform. The contractor must have experience in working to deploy the HINGE software system on the VA Enterprise Cloud (VAEC) Amazon Web Services (AWS) infrastructure, with expertise in system-to-system interconnectivity within the VA cloud. The contractor should demonstrate experience in successfully completing the Authorization to Operate (ATO) process within the Department of Veterans Affairs (VA). Community Care Dashboard Sustainment With many veterans being treated by community providers, it is critical that the correct treatments are delivered, and continuity of care information is returned to the VA. To achieve this goal, a dashboard solution is needed that will allow for the secure transfer of relevant clinical information to the treatment facility. When the treatment is complete, the same solution must allow for the VA to receive discrete treatment completion data values. Ideally, this method would be achieved with web-based forms, but the transfer of electronic medical record completed document forms would be acceptable. The provided platform must also support the uploading of Digital Imaging and Communications in Medicine (DICOM)-Radiotherapy extension (DICOM-RT) files related to the delivered treatment so that the VA can receive them. The provided solution for community data transfer must also provide an application programming interface (API) so that HINGE can securely extract data received from the community care providers. We are seeking subject matter expert services for the conceptualization, design, and implementation of the community care dashboard platform. The contractor will provide deployable software in the VA enterprise cloud as well as any customer support to deal with user training, account management and any integration services with the community care practices. The contractor must demonstrate experience working the Operational Ontology for Oncology (O3) to define the oncology specific clinical and dosimetry data elements required to be including in the community provider completed summary forms. Radiation Oncology Qualified Medical Physicist The National Radiation Oncology Program (NROP) requires subject matter expertise to support the Radiotherapy Incident Reporting and Analysis Program that captures adverse events and near miss/good catch data. The events reported in this program must be analyzed by a qualified medical physicist (QMP). The essential services are to be performed by a QMP to fully analyze reported incidents and provide feedback as a formal report to radiation oncology services for patient safety and radiotherapy process improvement. The average number of reported incidents is expected to be 50 incidents per quarter. The QMP shall have a minimum of 10 years of clinical experience in the state-of-the-art radiotherapy that includes, Brachytherapy, External Beam Therapy (3DCRT, IMRT, SBRT, and SRS), and Radiopharmaceutical therapy. QMP shall have Board certification Therapeutic Medical Physics and Nuclear Medicine Physics. QMP shall have demonstrated experience in the analysis or radiotherapy incidents, incident root cause analysis, failure mode and effect analysis, fault tree analysis and working knowledge of radiotherapy error reporting taxonomy. In addition, the QMP shall be knowledgeable in regulatory requirements for the safe use of radiation in cancer treatments. The contractor shall provide the following services for the Radiotherapy Incident Reporting project: - Web-based in-depth review of each reported incident, on-line communication with the reporter to get supplemental information to complete incident analysis and create a patient safety work product (PSWP) that includes the corrective action plan for the submitter. - Collaborate with clinical medical physicists and radiation oncology staff at our 41 VA facilities to develop targeted interventions and recommendations. - Participate in regularly scheduled calls with the service chiefs, medical physicists, radiation therapists/dosimetrists to provide a report on lessons-learnt from the reported incidents since the preceding call. - Generate quarterly newsletter highlighting lessons-learnt from reported incidents. In addition, prepare a quarterly report on reported events for the National Radiation Safety Committee (NRSC) of VA. - Provide guidance and expertise in policy recommendations and clinical best practices. - Regularly communicate with ROS to address their questions regarding Radiotherapy Incident Analysis. Set up regular virtual office hour (1 hour/week) for end-users. Ongoing Professional Practice Evaluation (OPPE) Data Management and User Support We are seeking professional services for Ongoing Professional Practice Evaluation (OPPE) Data Management and User Support to enhance the quality of patient care within our VA Radiation Oncology facilities. The contractor will be responsible for two core functions. First, the Data Analyst Services will ensure the accurate management of OPPE data, report generation, and collaboration with radiotherapy vendor platforms for data assessment. This includes supporting software packages for remote peer review and maintaining quality assurance standards that align with or exceed the stringent accreditation standards outlined by the American Society for Radiation Oncology (ASTRO) and the American College of Radiology (ACR). Second, customer support services which will be crucial in providing vital user support to our VA Radiation Oncology physicians. This support includes addressing queries, facilitating OPPE participation, and collaborating with radiotherapy vendor platforms, provided by a VHA contractor, to define and implement workflows that streamline OPPE evaluations. Retrospective Clinical Data Extraction The Retrospective Clinical Data Extraction from Clinical Notes Pilot Project is an initiative aimed at harnessing cutting-edge data extraction techniques, including Large Language Model (LLM) methodologies, to unlock invaluable clinical insights from unstructured clinical notes within the VA's VistA/CDW Electronic Medical Record systems. This project represents a pivotal step in enhancing research capabilities, improving data accessibility, and ultimately elevating the quality of healthcare delivery. To accomplish these goals, we are seeking a contractual data scientist service that will serve as a vital partner in this endeavor. This includes executing Large Language Models on VA datasets within the VA-enterprise cloud infrastructure, extracting clinical data from unstructured clinical notes using advanced LLM techniques, cleaning and organizing extracted data to ensure accuracy and consistency, retrieving clinical notes from the VistA/CDW Electronic Medical Record systems, and developing, training, and executing open-source Large Language Models to process VA clinical notes efficiently. Additionally, the contractor will conduct a comprehensive Data Accuracy Verification Study to ensure the reliability and quality of the extracted information before exporting the finalized data back to the VA's corporate data warehouse (CDW). Experience with the internal workings of the VA CDW is a prerequisite for the contractor. 3. Performance Period: The period of performance is a twelve-month based period with four option periods. 4. Type of Contract: Firm-Fixed-Price 5. Place of Performance: Work will be performed remotely. CONTRACT AWARD MEETING The contractor shall not commence performance on the tasks in this PWS until the CO has conducted a kick-off meeting or has advised the contractor that a kickoff meeting is waived. GENERAL REQUIREMENTS 1. For every task, the contractor shall identify in writing all necessary subtasks (if any), associated costs by task, together with associated sub-milestone dates. The contractor's subtask structure shall be reflected in the technical proposal and detailed project management plan (PMP). 2. All written deliverables will be phrased in layperson language. Statistical and other technical terminology will not be used without providing a glossary of terms. 3. Where a written milestone deliverable is required in draft form, the VA will complete their review of the draft deliverable within 15 calendar days from date of receipt. The contractor shall have 15 calendar days to deliver the final deliverable from date of receipt of the government's comments. D. SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES Description of Tasks and Associated Deliverables: Task One: Provide sustainment and enhancement support for the HINGE application. Deliverable One: Provide monthly progress report on the HINGE sustainment activities include deployments and implementation at multiple VA sites. Task Two: Support the ATO process and GovCloud deployment. Deliverable Two: Provide monthly documentation on the required security improvement, VA Enterprise SSO integration, and HINGE deployment in the GovCloud environment. Task Three: Support the community care dashboard development and sustainment. Deliverable Three: Provide monthly documentation of the community care dashboard development and sustainment efforts including the cybersecurity and ATO progress. Task Four: Support the clinical data extraction from clinical notes. Deliverable Four: Provide monthly documentation of the status of the clinical data extraction including metrics on the types of clinical notes, data elements and accuracy percentage, including the status of data interface to store the extracted data in the CDW database. E. SCHEDULE FOR DELIVERABLES 1. The contractor shall complete the monthly schedule of each deliverable specified in section D. 2. Unless otherwise specified, the number of draft copies and the number of final copies shall be the same. 3. If for any reason the scheduled time for a deliverable cannot be met, the contractor is required to explain why (include the original deliverable due date) in writing to the CO, including a firm commitment of when the work shall be completed. This notice to the CO shall cite the reasons for the delay, and the impact on the overall project. The CO will then review the facts and issue a response in accordance with applicable regulations. F. CHANGES TO STATEMENT OF WORK Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor. G. REPORTING REQUIREMENTS Two months after award of contract submit a detailed document containing assessment of system and proposed list of improvements. Every month provide status reports detaining the status of the HINGE architecture improvements. By the 15th of the six-month of this contract provide a final document describing technologies and techniques that could be used to extend the HINGE system in the future. All reports should be submitted to the COR electronically, Ms. Edwinette Moses at Edwinette.moses@va.gov. Ms. Moses will provide to the VA HINGE team for review before certifying invoices. H. SECURITY - The C&A requirements do not apply, and a Security Accreditation Package is not required. Information System Security The contractor will have access to VA data or computers. Contractor Personnel Security All contractor employees will have access to the Department of Veterans Affairs computer systems. Position Sensitivity - The position sensitivity has been designated as TBD Background Investigation - Background investigations will be required. J. CONFIDENTIALITY AND NONDISCLOSURE It is agreed that: 1. The preliminary and final deliverables and all associated working papers, application source code, and other material deemed relevant by the VA which have been generated by the contractor in the performance of this task order are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. 2. The CO will be the sole authorized official to release verbally or in writing, any data, the draft deliverables, the final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order presented to the contractor shall be submitted to the CO for response. 3. Press releases, marketing material or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.