36C24524Q0507.docx

36C24524Q0507

PAGE 1 OF

1. REQUISITION NO.

2. CONTRACT NO.

3. AWARD/EFFECTIVE DATE

4. ORDER NO.

5. SOLICITATION NUMBER

6. SOLICITATION ISSUE DATE

a. NAME

b. TELEPHONE NO. (No Collect Calls)

8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY

CODE

10. THIS ACQUISITION IS

UNRESTRICTED OR

SET ASIDE:

% FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ

IFB

RFP

15. DELIVER TO

CODE

16. ADMINISTERED BY

CODE

17a. CONTRACTOR/OFFEROR

CODE

FACILITY CODE

18a. PAYMENT WILL BE MADE BY

CODE

TELEPHONE NO.

UEI:

EFT:

PHONE:

FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER 18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19.

20.

21.

22.

23.

24.

ITEM NO.

SCHEDULE OF SUPPLIES/SERVICES

QUANTITY

UNIT

UNIT PRICE

AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA

26. TOTAL AWARD AMOUNT (For Govt. Use Only) 27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA

ARE

ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________

29. AWARD OF CONTRACT: REF. ___________________________________ OFFER

COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND

DATED ________________________________. YOUR OFFER ON SOLICITATION

DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY

(BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE

ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED

SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER) 30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION

(REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE

Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

05-16-2024 Amy Ritchey, Amy.Ritchey@va.gov

05-28-2024 11:00 am

EDT

36C245 Department of Veterans Affairs Network Contracting Office 5 510 Butler Avenue, Bldg. 306A Martinsburg, WV 25405

X

541715 1000 Employees

N/A

Department of Veterans Affairs Veterans Health Administration National Radiation Oncology Program 120 Broad Rock Blvd.

Richmond VA 23249 36C245 Department of Veterans Affairs Networking Network Contracting Office 849 International Drive Linthicum, MD 21090

PAYMENT WILL BE MADE BY

FSC e-Invoice Payment Invoice must be submitted electronically http://www.fsc.va.gov/einvoice.asp Invoice Setup Information 1-877-489-6135

See CONTINUATION Page Contractor shall provide subject matter expert services to sustain the central intranet-based QA database with dash-board software and HINGE applications accessible at each VHA radiation oncology in accordance with the statement of work.

Period of performance will be a base plus one additional option year.

Contractor shall be responsible for the correct title classification of workers and compliance with all applicable wage and hour laws.

An amendment will be posted to respond to RFQ questions received by the deadline. Please submit questions in writing to veronica.dillar@va.gov by 5/22/24 3:00 PM EST.

No phone calls will be accepted.

See CONTINUATION Page

Amy Ritchey Contracting Officer

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C245 Department of Veterans Affairs Network Contracting Office 5 510 Butler Avenue, Bldg. 306A Martinsburg, WV

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

3. INVOICES: Invoices shall be submitted in arrears:

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

B.2 STATEMENT OF WORK (SOW)

A. 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 twelve months (12) based period with one 12 twelve months (120 option period.

4. Type of Contract: The Government shall award a Firm Fixed Price contract.

5. Place of Performance: Work will be performed remotely.

B. CONTRACT AWARD MEETING

The contractor shall not commence performance on the tasks in this PWS until the COR has conducted a kick-off meeting or has advised the contractor that a kickoff meeting is waived.

C. 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.

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 COR, including a firm commitment of when the work shall be completed. This notice to the COR shall cite the reasons for the delay, and the impact on the overall project. The COR 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 COR in accordance with the SOW 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.

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor’s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination

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 Low, Tier 1 Background Investigation – Background investigations will be needed.

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 contract are the exclusive property of the U.S. Government and shall be submitted to the COR at the conclusion of the contract.

2. The COR 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 contract. No information shall be released by the contractor. Any request for information relating to this contract presented to the contractor shall be submitted to the COR 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 COR and CO.

Training Contractor employee requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

1.) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

2) Successfully complete the VA Privacy and Information Security Awareness and Rules of Behavior training and annually complete required security training;

3) Successfully complete the appropriate VA Privacy and HIPAA training and annually complete required privacy training.

a. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

b. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

Support for Quality and Safety Initiatives Project Manager Contract Period: Base POP Begin: 06-01-2024 POP End: 05-31-2025 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology) PRODUCT/SERVICE CODE: R410 - Support - Professional: Program Evaluation/Review/Development

Health Informatics Specialists

POP Begin: 06-01-2024 POP End: 05-31-2025 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Subject Matter Expert (Senior) Program Manager

POP Begin: 06-01-2024 POP End: 05-31-2025 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Health System Specialist

POP Begin: 06-01-2024 POP End: 05-31-2025 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Health Cybersecurity Analyst

POP Begin: 06-01-2024 POP End: 05-31-2025 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Health Informatics Specialist (Senior)

POP Begin: 06-01-2024 POP End: 05-31-2025 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Radiation Oncology Domain Expert

POP Begin: 06-01-2024 POP End: 05-31-2025 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Health Data Analyst

POP Begin: 06-01-2024 POP End: 05-31-2025 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Health Data Scientist

POP Begin: 06-01-2024 POP End: 05-31-2025 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Support for Quality and Safety Initiatives Project Manager Contract Period: Option 1 POP Begin: 06-01-2025 POP End: 05-31-2026 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Health Informatics Specialists

POP Begin: 06-01-2025 POP End: 05-31-2026 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Subject Matter Expert Program Manager (Senior)

POP Begin: 06-01-2025 POP End: 05-31-2026 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Health System Specialist

POP Begin: 06-01-2025 POP End: 05-31-2026 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Health Cybersecurity Analyst

POP Begin: 06-01-2025 POP End: 05-31-2026 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Health Informatics Specialists (Senior)

POP Begin: 06-01-2025 POP End: 05-31-2026 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Radiation Oncology Clinical Domain Expert

POP Begin: 06-01-2025 POP End: 05-31-2026 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Health Data Analyst

POP Begin: 06-01-2025 POP End: 05-31-2026 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Health Data Scientist

POP Begin: 06-01-2025 POP End: 05-31-2026 PRINCIPAL NAICS CODE: 541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Page 1 of Page 1 of

SECTION C - CONTRACT CLAUSES

C.1 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default "program files" directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

(1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/ subcontractor is to perform;

(1) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

(2) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

(1) "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

(2) "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

(3) "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within days.

l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA…