ATTACHMENT A_SOO _36C10X21Q0231_Final.docx

Statement of Objectives (SOO) National Oncology Program Office Oncology Clinical Pathway Acquisition

1. Purpose The National Oncology Program (NOP) Office in Specialty Care Services, Department of Veterans Affairs, has a requirement for a clinical pathway that will assist NOP in the development of a national program of customized medical oncology pathways, implementation, and maintenance for the Veterans Health Administration (VHA).

2. Background The NOP Office in Specialty Care Services is responsible for oncology-related policy and programs in the Veterans Health Administration, the nation’s largest integrated healthcare system. The mission of NOP is to improve the lives of Veterans with cancer through Precision Medicine by implementing a learning healthcare model to quickly transition new knowledge into clinical practice and to maximize learning from clinical practice. To accomplish that mission, NOP manages multiple complementary and interdependent projects including: National Precision Oncology Program (NPOP), Oncology Clinical Pathways, TeleOncology service, PHASER pharmacogenomics partnership with Sanford Health, and the VA Cancer Registry System. NOP also partners with other program offices to provide oncology-related services including the VA Office of Research and Development (ORD). This includes the Precision Oncology Program for Cancer of the Prostate (POPCap) which collaborates with the Prostate Cancer Foundation for clinical research, and the Lung Cancer Precision Oncology Program (LPOP), also in partnership with National Center for Health Promotion and Disease Prevention, Office of Pulmonary/Critical Care/Allergy, and Office of Diagnostics/Radiology. Additional work with ORD includes Clinical Trials Matching, Million Veterans Program, and Access to Clinical Trials for Veterans. NOP also works with Genomic Medicine Service for telehealth-provided genetic counseling service.

The NOP is committed to the implementation of Clinical Pathways for the oncological care of Veterans. Clinical pathways are standardized, evidence-based disease management and treatment protocols, which encompass comprehensive cancer care from diagnostics to end of life treatment for homogenous patient groups. Unlike clinical guidelines that provide multiple options for many care decisions, a clinical pathway is a roadmap of the one preferred care plan for a practice or group. Implementation of a clinical pathway has been shown to reduce unwanted variation in care, and thus improve outcomes, reduce adverse effects and risks, and lower costs. Adherence to the latest evidence is a requirement in selecting and administering chemotherapy or other pharmacologic treatments for cancer [VHA DIRECTIVE 1413, June 6, 2019]. As the VA cares for a unique population, clinical pathways should be developed internally to accurately reflect the needs of the Veteran cancer patient in a process that is as free of bias as possible. The goals of adoption of clinical pathways in the VA are not only to standardize oncology care, but to ensure quality care is delivered safely and in a cost-effective manner.

Medical Oncology clinical pathways are detailed, evidence-based treatment protocols that delineate optimal treatment options for cancer patients and may include recommended dosing, time frames, and sequencing of therapies. Optimal pathways address the full spectrum of pathway care from diagnostic evaluation through first course of therapy, supportive care, post-treatment surveillance, to end-of-life care. Payers, healthcare systems, and providers are increasingly adopting these treatment management tools to help ensure high-quality cancer care for patients (www.asco.org).

The NOP Clinical Pathways Development Team has been working to formulate cancer-related clinical pathways. VHA-specific clinical pathways are intended to build upon known unique outcome-characteristics of the Veteran population and strengths of the VHA Oncology/Tele-Oncology programs. The initial pathway planning is focused on the two most prevalent malignancies (prostate & lung cancers) among this population and leverage the most recent advances in therapies for these conditions. NOP is interested in pathways from not only these two cancers but a broad range of cancer types. VA’s creation of clinical pathways will follow accepted criteria for high-quality clinical pathways in oncology (Zon RT et al, J Oncol Practice 2016; 13:207-210). Once developed, pathways are applicable system-wide. Integration of the pathways into the EHR will be piloted at pre-selected VA Medical Centers prior to system-wide implementation.

3. Scope A goal for the National Oncology Program Office is the development and implementation of oncology clinical pathways across the VHA.

To support the internal development of Oncology Clinical Pathways and extend and complement the pathway content, the Contractor shall deliver a Oncology Clinical Pathway that shall be inclusive of clinical content, that may be customized for use within the complex VHA EHR environment. This customization shall include self-service authoring, provide clinical decision support guidance with periodic updates, allow for opportunities for clinicians to participate in clinical pathway development and updates, include related clinical trials, and if required compatibility and/ potentially integration support into the Cerner electronical medical record.

4. Performance Objectives The Contractor will partner with the NOP Clinical Pathways Development Team on the implementation of customizable Oncology Clinical Pathways for a pilot setting to include guidance on customization and subscription for updates to the pathways as well as integration of the pathway with the VA EMR present and future (Cerner). The product offering shall include a plan for national use of VA customized oncology clinical pathways content.

The oncology clinical pathways to be built shall be customizable and maintainable by Government staff within the current and future VA EMR.

a. CLINICAL PATHWAY PACKAGE Obtain access to pathway content for wide arrange of tumor types. Pathway content must be created by or in conjunction with experts from NCI-designated Cancer Center(s). VA must be able to participate in the ongoing pathway review and creation process. A listing of the required cancer/tumor types is included in SOO Attachment B.

1. Clinical Content:

The Contractor shall provide clinical pathways and content that are expert-driven and evidence-based. The content shall be developed with the input of relevant disease and/or specialty experts and based upon the best available scientific evidence documented or disseminated clinical practice guidelines, peer-reviewed journals, and validated real-world data.

2. Self-service authoring Veterans are a unique population with demographics, health concerns and needs that differ from the general population as a whole (www.rand.org). In response, the VA health care system must be responsive and unique in its structure and delivery of care. Therefore, the clinical pathway shall have self-service authoring capability to allow editing of pathways to create and modify clinical content to best meet the needs of the Veteran population.

3. Clinical decision support guidance with periodic updates In response to the continuous advancement and innovations in medicine and technology, a component of the pathway system shall be a subscription or routine scheduled update from authenticated expert sources. This will allow for the best therapies based upon expert content be readily available for oncologist use. A full review of the pathway shall be performed and documented at least annually. Additionally, in response to innovations in care and technology a mechanism for ongoing rapid evaluation and revision is required.

4. Opportunities for clinicians to participate in clinical pathway development and updates

The product delivered shall include an open and transparent process for pathway development, review, and maintenance. Designated VA oncologists must have an opportunity to listen into pathway content meetings, submit agenda items for consideration, and designate a disease management lead as an active participant in review meetings.

5. Related Clinical Trial inclusion and exclusion criteria (e.g., disease indication, histological subtype, genomic markers, etc.)

Clinical trials for Veterans give patients access to emerging therapies, opportunities for earlier detection, proactive approaches as well as help researchers better understand disease. Clinical trials benefit our Veterans, but also address the VA’s 4th mission and advance cancer care for all Americans and individuals world-wide. To further these efforts, clinical pathway content shall include clinical trials with matching inclusion and exclusion criteria as options.

b. INTEGRATION

1. Initial Implementation effort with NOP Clinical Pathways Development Team A plan for implementation and initial use of clinical pathways by the National Oncology Program Office Clinical Pathways Development Team, with an emphasis on cost effectiveness, efficiency, and maintenance to ensure the most widespread deployment. Contractor will also provide ongoing guidance for integration, national spread, and implementation.

2. (Optional) Cerner integration A plan and path forward for the integration of the oncology clinical pathways into the Cerner EMR, if a process exists that would create efficiencies in updates and avoid duplication of effort on the part of the government. The Contractor shall leverage expertise in the areas of VHA information systems to include but not limited to: VISTA, CPRS, and Cerner to develop recommendations for clinical pathway build out, alignment, integration and implementation with consideration of current and future technology.

5. Type of Contract Firm Fixed Price (FFP)

6. Period of Performance The period of performance will be a Base Period of 12 months with two 12-month option years.

7. Place of Performance The primary place of performance will be Contractor location upon contract execution.

8. Quality Assurance Plan

STANDARD

SURVEILLANCE

METHOD

OUTCOME

PROJECT

MANAGEMENT,

MILESTONES,

AND SCHEDULE

agreed upon milestones per the approved PMP Poor performance may result in issuance of a Contractor Discrepancy Report (CDR), The Contractor’s performance on this TO Shall be reported to the Contractor Performance Assessment Reporting System (CPARS) on an annual basis. The CO and COR Shall make use of information from CDRs, as well as any additional knowledge and information available to them with respect to the Contractor’s performance, to complete the CPARS.

The Government Shall not pay for services that do not conform or do not meet performance standards or have not been properly rendered.

The Contractor Shall be given an opportunity to correct non-conforming services at no cost to the Government if the services are non-conforming or the contract requirement is unacceptable.

WRITTEN

COMMUNICATION

Uses correct English grammar, punctuation, and spelling 95% of the time; communicates information in a succinct and organized manner, produces written information that is appropriate for the intended audience. Written communication is consistently error-free and clear and concise so that the message is easily understood by others.

Random sampling by PM and COR

CUSTOMER

SUPPORT

Courteous and professional interactions to receive and fill task order deliverables and in providing order status. Customer (VA) support satisfaction, having no more than 5 incidents of dissatisfaction.

Customer Feedback and Complaints based on interactions with the Contractor

DELIVERABLES Contractor completion and submission of all deliverables.

Contractor will complete all required deliverables timely (100% Acceptable Quality Level) 100% Inspection/ Direct Observation

VA CORE VALUES AND TEAM DYNAMICS

Adherence to VA CORE Values in Interactions with VA Personnel, Contractors, and Customers

Sample/ Validated Customer Complaints

INVOICING

Timely and Properly Prepared Invoice

Inspection

9. Meetings For all meetings, the Contractor shall be responsible for providing meeting materials and administrative and facilitation support. Meetings will be conducted through an alternative method of communication (such as a teleconferencing), as approved by the Contracting Officer.

1. Post-award Kickoff Meeting Within 10 business days of contract award (base year only), the Government will conduct a virtual post-award kickoff meeting (specific date and time to be mutually agreed-upon).

2. Weekly Project Work Group Meetings Weekly work group meetings to be conducted on (specific date and time to be mutually agreed-upon). The Contractor is responsible for reporting the previous week’s activities (including any risks, issues, or concerns, and actual or recommended actions for their mitigation), and projected activities for the following week

3. Monthly Project Status Report Monthly status meetings to be conducted on (specific date and time to be mutually agreed-upon). The Contractor is responsible for reporting the previous month’s activities (including any risks, issues, or concerns, and actual or recommended actions for their mitigation), and projected activities for the following month.

4. Program Management Review The Government will conduct quarterly program management reviews to review the progress of the program, identify any risks, issues, or concerns, and provide feedback on the Contractor’s progress and performance. The Contractor shall provide written data and verbal presentations as to the financial status of the work (projected vs. incurred costs), any identified any risks, issues, or concerns (and their mitigation or its plans for their mitigation.]

10. Travel The Government does anticipate limited travel under this effort. Travel must be pre-approved by the Contracting Officer (CO) and COR and conducted in accordance with Federal Travel Regulations (FTR). Each Contractor invoice must include copies of all receipts that support the travel costs claimed in the invoice. Travel will be reimbursed at cost per the FTR and shall not include any indirect costs. Local travel within a 50-mile radius from the Contractor's facility or assigned government provided facility is considered the cost of doing business and will not be reimbursed. This includes travel, subsistence, and associated labor charges for travel time. Travel performed for personal convenience and daily travel to and from work at the Contractor's facility or government assigned facility will not be reimbursed.

11. Material Other Direct Costs Material Other Direct Costs may include oncology clinical pathways and software.