caBIG® Clinical Information Suite Project Overview

1. caBIG® Clinical Information Suite Project Overview Varian Medical Systems Meeting February 9-10, 2011

2. caBIG® Clinical Information Suite Introductions & Meeting ObjectivesPresenter: Corinne Blair

3. Agenda • Participant Introductions • caBIG® Clinical Information Suite (caCIS) Team • Varian Team • Meeting Purpose & Objectives • caBIG® caCIS Project • Project Overview • Business Capability Overview • Technical Overview • Integration Strategy Overview • End of day recap, action items or discussion

4. caBIG® Clinical Information Suite Team • NCI Representative – John Speakman Associate Director for Clinical Products and Programs, Center for Biomedical Informatics and Information Technology, National Cancer Institute • SAIC-F Contracting Officer Technical Rep – Nancy Roche • caCIS Chief and Lead Architects – John Koisch and Paul Boyes • caCIS Analysis Lead – Marti Velezis • caCIS Deployment Lead – Phil Gelda • caCIS Stakeholder Manager – Corinne Blair

5. Meeting Purpose & Objectives Open dialog and engagement with software vendors in the oncology market space is a key part of our project’s mission … • Our NCCCP partners and the broader Cancer Care Community are supported by a large vendor community • We are striving to assist the Cancer Care Community in providing more highly focused care to cancer patients through IT enabled translational medicine • NCI is not a software vendor and can only succeed in this mission when vendors adopt and/or interoperate with caBIG® specifications and solution components

6. Meeting Purpose & Objectives Ideal targeted outcomes from this meeting and any follow-up dialog include … • Near term • Clear feedback regarding the this project and the deliverables it is targeted to produce • Establishment of a collaborative relationship to help support our shared NCCCP stakeholders • Medium to Longer Term • Progressive incorporation of caBIG® caCIS based specifications and standards / capabilities into the applicable product life-cycles

7. Meeting Purpose & Objectives Proposed objectives for this meeting … • Provision of Context • Overview of the caCIS project goals, benefits, business capabilities and caCIS technical architecture and specifications • Getting to Specifics • Provision of specific details about selected capabilities to stimulate meaningful dialog • Open Discussion • Enabling an interactive and open dialogue to validate assumptions and seek feedback

8. caBIG® Clinical Information Suite Project Overview Presenter: John Speakman

9. Building a Smarter Health System • Preparation for 21st Century Biomedicine, Meaningful Use for Electronic Health Records, and Outcomes Management • Integration with various silos of clinical information sources (e.g., clinical, administrative and research) to provide additional value to the ambulatory oncology communities by using the information for extended business capabilities • Aim for meaningful interoperability between Health IT solutions and organizations for improved patient care

10. Business Problem & Opportunity • System Wide Challenges • Isolated information “islands” • Siloed health information infrastructure • Significant expectations for increased useof health record technology through HITECH Act stage 1, 2, and 3 targets and ensuing standards • A need for more modular, interoperable softwaresolutions to meet the needs of diverse clinical settings • Ambulatory Oncology Sector Challenges • Limited availability of EHR solutions focused on the unique needs of the ambulatory oncology sector which are ready for the emerging demands of 21st century biomedicine • Go-Forward Opportunities • Significant progress from ASCO & NCI collaborative efforts to document clear ambulatory oncology EHR functional requirements • ARRA funding to address technology gaps • A willing array of NCI Community Cancer Centers Program (NCCCP) implementation partners

11. caBIG® Clinical Information Suite: A collaborative national effort American Society of Clinical Oncology (ASCO) Began evaluating issue, involving end users Engaged the vendor community through its EHR lab, utilizing unique case scenarios Developed high level requirements document/white paper outlining the issue cancer Biomedical Informatics Grid (caBIG®) Vendor technology evaluation Problem assessment Technical Specification NCI Community Cancer Centers Program (NCCCP) Oncology EHR Laboratory Other domain experts

12. Oncology-Extended EHR Clinical Information Suite The National Cancer Institute (NCI), through its Cancer Biomedical Informatics Grid (caBIG®) program, is leveraging the nation’s $44 billion investment in Healthcare Information Technology to fuel research in the following way: NCI has collaborated with the American Society of Clinical Oncology (ASCO) and other professional societies to develop specifications for an “oncology-extended Electronic Health Record” to fill a gap in existing Electronic Health Record (EHR) functionality for practicing ambulatory oncologists This NCI/ASCO project is called Clinical Oncology Requirements for the Electronic Health Record (CORE)

13. Project Scope • NCI is developing a series of software modules (referred to as “capabilities”) collectively known as the caBIG® Clinical Information Suite: • Modules are based on the CORE specifications and the expressed needs of the NCI community • They will integrate with EHRs to deliver functionality and interoperability useful to the practicing oncologist • They will support the specific oncology-related data collection needs of practicing oncologists, and build the “bridge” between clinical care and research • They will leverage NCI’s investment in a scalable services-based infrastructure • They will include both clinical (collecting data) and administrative (managing the trial) functionality, all available under a non-viral license for use by vendors and others in the community

14. Project Purpose To support the ambulatory oncology clinical care communities and open-source and commercial software vendors by delivering a series of highly configurable modular business capabilities and specifications while meeting the ARRA/HITECH meaningful use requirements. These capabilities will- • Be highly modular and configurable to address a wide range of clinical settings via workflow, user interface and semantics • Provide key ambulatory oncology functionality and standards-based health information exchange • Position users for effective integration with other clinical, administrative and research systems • Leverage existing HIT standards and extend these standards from an oncology perspective where appropriate • Be released with a full set of specifications that can be used by vendors and implementers to leverage all or portions of the project deliverables

15. Target Goals (One or more of these goals by close of project) Architectural Adoption by Industry Software solution vendor(s) consumption of platform independent caBIG® Clinical Information Suite specifications in the development/extensionof the product suite(s). • Measure of success: At least 1 service specification being utilized by industry to develop production viable functionality within a product. • Solution Adoption through the Open Health Tools (OHT) Community • Business capability and/or reference implementation consumption by the OHT community to integrate and/or repackage for the health IT market. • Measure of success: At least 1 fully specified and developed business capability consumed by the open source community and/or being implemented as a production implementation by the open source community vendors. Clinical Community Adoption One or more business capabilities and/or the full reference implementation being used in a daily production manner at ‘in scope’ early adopter site(s). Measure of success: At least 1 fully specified and developed business capability in production use in a clinical care setting in 1 or more National Community Cancer Center Program (NCCCP) sites. caBIG® CLINICAL Information Suite Goals

16. caBIG® Clinical Information Suite The caBIG® Clinical Information Suite modules can be used (as either specifications or software) in conjunction with an EHR platform (proprietary or open source) to extend and/or compliment an EHR that enables ambulatory oncology NCI has selected Tolven, as a representation open-source EHR platform that has met our technical requirements (HL7 V3 RIM based, ISO 21090 data types, etc.) to integrate the caBIG® Clinical Information Suite and thus deliver an end-to-end, deployable EHR as a Reference Implementation

17. caBIG® Clinical Information Suite Deliverables Deliverables are expected to include: A detailed, industry-validated requirements document (CORE, developed with ASCO) An HL7 (Health Level 7) validated functional profile for ambulatory oncology based on the ASCO/NCI CORE requirements document and the HL7 EHR functional model A set of structured use cases and application/service specifications documents, usable to guide development A number of capabilities, i.e., software modules including both clinical (collecting data) and administrative (managing the trial) functionality, all available under a non-viral license for use by vendors and others in the community

18. caBIG® Clinical Information Suite Iteration and Release Process Development iterative and incremental project where feedback is essential Establishing formal focused review and feedback of project outputs from the iteration and release cycles New and updated modules with increased functionality will be released, iteratively and incrementally, over the lifecycle of the project Spans all project deliverables Membership to include, but not limited to key representatives from NCI Divisions/Centers, NCCCP project 18 sites and their supporting vendors, project team, and DE/SME’s

19. Aim for Meaningful and Working Interoperability • Exchange data accurately, effectively, and consistently, using the information that has been exchanged • Data is exchanged and/or merged across the continuum of care, shared with the patient and used for reporting requirements • Adoption of services to allow computable data exchange between clinicians, researchers and patients • Advance NCI’s objective of interoperability in, and between, research and patient care • Deploy and use standards that enable computer systems to exchange information in a way that promotes patient safety and is secure and reliable.

20. NCI CBITT Strategic PositionQuestions? Consume/Contribute Validate Inform • CBIIT consumes and developsconformant standards-based specifications to resolve business problems • CBIIT validates the applicability of specifications via reference implementations • CBIIT informs the commercial and open-source vendor communities of the “state of the art” by deploying/handing off its reference implementations.

21. caBIG® Clinical Information Suite Business Capabilities Overview Presenter: Marti Velezis

22. Topics for Discussion • Sources of Requirements • Overview of Business Capabilities • High-Value Business Capabilities • Detailed Business Capability Definitions • Administrative • Diagnostic • Therapeutic • Disease Response • Confirm the appropriateness of the proposed capabilities • Identify missing capabilities

23. Sources for Business Capabilities • caBIG® Clinical Information Suite domain experts • HL7 Ambulatory Oncology Functional Profile • American Society of Clinical Oncology (ASCO) Oncology EHR Functional Requirements • Requirements developed by St. Joseph Hospital Orange County, California • These business capabilities are also aligned with the Meaningful Use criteria as published in the January 13, 2010 Federal Register

24. HL7 Functional Model • The HL7 EHR System Functional Model (EHR-S FM) provides a reference list of functions that may be present in an Electronic Health Record System. • The function list enables consistent expression of system functionality. This EHR-S Model, through the creation of Functional Profiles, enables a standardized description and common • The EHR-S FM lists the set of all functions that COULD be present in various EHR systems. • This subset of functions characterizes the type of system being defined and is referred to as a “functional profile”. • The AOFP is one such functional profile.

25. Ambulatory Oncology Functional Profile (AO-FP) • Provide one overall view of the needs of oncology care providers with respect to electronic patient records for both direct care, supportive and infrastructure functions. • Encourage EHR vendors to incorporate functions into their products that are necessary to support the unique requirements of the ambulatory oncology setting.

26. Business Capability Categorization • Primary, High-Value Oncology Business Capabilities– this includes business capabilities that will address the specific business needs of the ambulatory oncology community, such that the use of EHR information can be leveraged to optimize an existing activity or enable the clinician or patient to conduct a new activity. • Supporting Business Capabilities– this includes business capabilities that will enable retrieval or exchange of information to support one or more of the high-value Oncology Business capabilities. • Commodity Business Capabilities– this includes business capabilities that are expected to be provided by the EHR platform(s) that will exist at the deployment sites (note: this may include one or many systems that make up such a platform – e.g., patient management system and patient scheduling system). Note: EHR Platform is defined in this context as one or more systems that make up the commodity (i.e., readily available, commercial solutions) services and/or systems to meet the basic business capabilities of a research and/or clinical care setting.

27. Business Capability by Type caBIG® Clinical Information Suite will design and build Capabilities Well understood in Industry (Built by others) caBIG® Clinical Information Suite will interface

28. Primary, High-Value Oncology Business Capabilities • Oncology Business Capabilities are considered high-value because they focus on the key opportunities that will demonstrate some of the benefits of 21st Century Biomedicine including, but not limited to: • improving the survival rate for cancer patients through better utilization of healthcare and research information • integrating information from the research and healthcare communities • providing the infrastructure to improve the availability and usefulness of the information collected that is simply not available in existing systems.

29. Supporting Business Capabilities • Supporting Capabilities are those that caCIS will need to have interfaces to • Most likely these capabilities are developed by others or in collaboration with others

30. Commodity Capabilities • Commodity Capabilities are those well understood by Industry • Most likely these capabilities are provided or built by others

31. High-Value Business Capabilities • Each of the High-Value business capabilities fits into one of the following categories or dimensions of information: • Administrative • Diagnostic • Therapeutic • Disease Response • Each of the dimensions are required to prepare for the measurement of outcomes for individual patients as well as patient populations.

32. Business Capability by Type Outcomes

33. Administrative Capabilities • Business capabilities that have been identified as providing essential improvement in the ambulatory oncology community • As much as possible, the unique needs of ambulatory oncology has been considered – even within the administrative capabilities

34. Diagnostic Capabilities • The dimension of diagnostic capabilities requires several supporting capabilities of retrieving information from the surgeon, pathologist or radiologist to assess the diagnosis of a patient and one High-Value oncology business capability – Cancer Staging.

35. Therapeutic Capabilities • The dimension of therapeutic capabilities includes the use of therapeutic information in the ambulatory oncology setting, including: • Chemotherapy Management • Treatment Plan Management • Patient Trial Finder

36. Disease Response to Treatment Capabilities • Disease Response to Treatment • Response Evaluation Criteria in Solid Tumors (RECIST) • Tumor Burden • Functional Assessment/Performance Scales • ECOG • Karnofsky • Survival • Death Information

37. caBIG Clinical Information Suite Business Capabilities Detailed Business Capability Definitions

38. Administrative Capabilities

39. Administrative Capabilities: Referral Management • Describes the referral process for accepting patients into the ambulatory oncology care system and ensuring the proper transfer of care • Create, send, receive, and approve referrals • Obtain the electronic documents associated with the referrals • The ability to electronically create, send, receive, and approve referrals and maintain the electronic documents associated with the referrals.

40. Administrative Capabilities: Referral Management (cont.) • The ability to review all referred patients to determine if the patient meets the criteria for the practice, identify any additional clinical information that is required via a request for additional information. • The ability to exchange relevant information between providers to help reduce the duplication of data collection or diagnostic test(s) • The electronic referral includes all of the pertinent demographic, clinical, and financial information.

41. Administrative Capabilities:Chemotherapy Reimbursement &Costing • Chemotherapy Reimbursement and costing • Ambulatory Oncology offices may require direct procurement of chemotherapy medications • Cost and availability may have an affect on chemotherapy scheduling Provide the requisite administrative components of managing the ordering of chemotherapy for administration to patients, while containing costs for the practice. • Identifying the costs and obtain adequate supplies of chemotherapy and related medicines administered by the oncologist.

42. Diagnostic Capabilities

43. Diagnostic Capabilities • Cancer Staging • Based on the American Joint Committee on Cancer (AJCC) guidelines • Capture of Clinical and Pathologic Stage • Availability of guidelines for T,M,N and by cancer type • Ability to associate supporting clinical documents to the cancer stage

44. Diagnostic CapabilitiesCancer Staging • Solid Tumor cancer staging describes the severity of a person’s cancer based on the extent of the original (primary) tumor and whether or not cancer has spread in the body. • Cancer staging, depending on the cancer disease, consists of an anatomic stage (TNM) and may include prognostic factors.

45. Diagnostic CapabilitiesCancer Staging (cont.) • Staging helps the doctor plan the appropriate cancer care treatments. All clinical practice guidelines for the management of cancer use the assessment of the extent of the disease and the cancer stage at diagnosis to guide appropriate treatment recommendations. • The cancer stage can be used to estimate the patient’s prognosis. • The cancer stage is important in identifying clinical trials that may be suitable for a particular patient.

46. Therapeutic Capabilities

47. Therapeutic Capabilities • Chemotherapy Management • Schedule Patient for Chemotherapy appointment (e.g., medication, resources, staff, etc.) • Plan, Order, Prepare (e.g., mix), and Administer Chemotherapy medications, Order Sets and flow sheets • Document patient tolerance • Manage and Document response to chemotherapy treatment (e.g., adverse reactions) • Manage administration of Anti-cancer drugs

48. Therapeutic CapabilitiesChemotherapy Management Business Needs • Providers and payers require processes to make chemotherapy management more efficient and cost-effective • Aim to minimize dosing errors and treatment complications • Ability to track important factors such as total cumulative doses, patient tolerance of previous medications/regimens • Provide improved uniformity in data captured and reported from the ordering, administration, and results of chemotherapy and other cancer therapies can help identify additional factors impacting outcomes

49. Therapeutic Capabilities (cont.) • Treatment Plan Management • Generate, Modify and Close or Discontinue Treatment Plans for patients based on known treatment regimens • Document use of standard or best practice guidelines • Document adherence with treatment plans based on patient’s response to treatment

50. Treatment Planning Business Need • Enable the availability of treatment plans across a multi-disciplinary clinical care delivery team • Provide a patient’s clinical data in a consolidated, single view for a health care provider • Foster coordinated planning, in an effort to result in improving patient’s safety and the effectiveness of the treatments • Improve Patient communication about their treatment(s)