Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Transition of Care Initiative Elements in Transition of Care Use Case 8/1/2011 8/1/2011 1 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Version Control Date 04/08/11 Version Owner v1.0 UCR Support Team 05/24/11 v1.1 UCR Support Team Source ToC Workgroup Consensus Dr. Thomas Caruso, Dr. Holly Miller Description of Changes Dr. Caruso: Addressed and resoluted all comments brought forth by ToC Harmonization Workgroup Members Dr. Miller: Update to scope to include “Other Providers”. 8/1/2011 2 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Table of Contents List of Figures ................................................................................................................................................ 4 List of Tables ................................................................................................................................................. 4 1.0 Preface and Introduction ........................................................................................................................ 6 2.0 Overview and Scope................................................................................................................................ 6 2.1 In Scope ............................................................................................................................................... 7 2.2 Out of Scope........................................................................................................................................ 7 2.3 Background ......................................................................................................................................... 7 2.4 Policy Issues ........................................................................................................................................ 8 2.5 Regulatory Issues ................................................................................................................................ 8 2.6 Communities of Interest ................................................................................................................... 10 3.0 Challenge Statement ............................................................................................................................. 11 4.0 Value Statement ................................................................................................................................... 14 5.0 Use Case Assumptions .......................................................................................................................... 14 6.0 Pre-Conditions....................................................................................................................................... 15 7.0 Post Conditions ..................................................................................................................................... 16 8.0 Actors and Roles ................................................................................................................................... 16 9.0 Use Case Diagram ................................................................................................................................. 17 10.0 Scenario 1: The Exchange of Clinical Summaries from Provider to Provider...................................... 19 10.1 User Stories of Scenario 1 ............................................................................................................... 19 10.1.1 Base Flow of Scenario 1 ........................................................................................................... 28 10.1.2 Activity Diagrams for Scenario 1 .............................................................................................. 30 10.2 Functional Requirements of Scenario 1 .......................................................................................... 32 10.2.1 Information Exchange Requirements of Scenario 1 ................................................................ 32 10.2.2 System Requirements of Scenario 1 ........................................................................................ 32 10.3 Sequence Diagrams of Scenario 1 ................................................................................................... 33 11.0 Scenario 2: The Exchange of Clinical Summaries between Provider to Patient in Support of Transitions of Care ...................................................................................................................................... 35 11.1 User Stories of Scenario 2 ............................................................................................................... 35 11.1.1 Base Flow of Scenario 2 ........................................................................................................... 37 11.1.2 Activity Diagrams of Scenario 2 ............................................................................................... 39 11.2 Functional Requirements of Scenario 2 .......................................................................................... 41 11.2.1 Informational Interchange Requirements of Scenario 2 ......................................................... 41 8/1/2011 3 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case 11.2.2 System Requirements of Scenario 2 ........................................................................................ 41 11.3 Sequence Diagrams of Scenario 2 ................................................................................................... 42 12.0 Issues and Obstacles ........................................................................................................................... 44 13.0 Dataset Considerations ....................................................................................................................... 44 APPENDICES .............................................................................................................................................. 61 Appendix A: Related Use Cases............................................................................................................... 61 Appendix B: Previous Work Efforts Related to Clinical Information Exchange ..................................... 61 Appendix C: Privacy and Security Assumptions ...................................................................................... 62 Appendix D: Glossary .............................................................................................................................. 63 Appendix E. References .......................................................................................................................... 65 List of Figures Figure 1: Use Case Diagram ........................................................................................................................ 17 Figure 2: Context Diagram .......................................................................................................................... 18 Figure 3: Activity Diagram of Scenario 1 User Story 1 ................................................................................ 30 Figure 4: Activity Diagram of Scenario 1 User Story 2 ................................................................................ 31 Figure 5: Sequence Diagram of Scenario 1 User Story 1............................................................................. 33 Figure 6: Sequence Diagram of Scenario 1 User Story 1............................................................................. 34 Figure 7: Activity Diagram of Scenario 2 User Story 1 ................................................................................ 39 Figure 8: Activity Diagram for Scenario 2 User Story 2 ............................................................................... 40 Figure 9: Sequence Diagram for Scenario 2 User Story 1 ........................................................................... 42 Figure 10: Sequence Diagram of Scenario 2 User Story 2........................................................................... 43 List of Tables Table 1: Communities of Interest ............................................................................................................... 11 Table 2: Actors and Roles of Use Case ........................................................................................................ 16 Table 3: Actors and Roles for Scenario 1 User Story 1 ................................................................................ 25 Table 4: Actors and Roles for Scenario 1 User Story 2 ................................................................................ 26 Table 5: Base Flow of Scenario 1 User Story 1 ............................................................................................ 29 Table 6: Base flow of Scenario 1 User Story 2 ............................................................................................ 29 Table 7: Information Exchange Requirements of Scenario 1 ..................................................................... 32 Table 8: System Requirements of Scenario 1 ............................................................................................. 32 Table 9: Actors and Roles of Scenario 2 User Story 1 ................................................................................. 35 Table 10: Actors and Roles of Scenario 2 User Story 2 ............................................................................... 36 8/1/2011 4 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Table 11: Base Flow of Scenario 2 User Story 1 .......................................................................................... 37 Table 12: Base Flow of Scenario 2 User Story 2 .......................................................................................... 38 Table 13: Informational Exchange Requirements of Scenario 2 User Story 1 ............................................ 41 Table 14: System Requirements of Scenario 2 ........................................................................................... 41 Table 15: Dataset for Discharge Instructions .............................................................................................. 47 Table 16: Dataset for Discharge Summary.................................................................................................. 51 Table 17: Dataset for Clinical Summary ...................................................................................................... 56 Table 18: Dataset for Clinical Summary for Specialist Notes ...................................................................... 61 8/1/2011 5 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case 1.0 Preface and Introduction To fully realize the benefits of health IT, the Office of the National Coordinator for Health Information Technology (ONC), as part of the Standards and Interoperability (S&I) Framework is developing Use Cases that define the interoperability requirements for high priority health care data exchange; maximize efficiency, encourage rapid learning, and protect patients’ privacy in an interoperable environment. These Use Cases address the requirements of a broad range of Communities of Interests including; patients, their significant others and family members, providers, vendors, standards organizations, public health organizations, and Federal agencies. These Use Cases describe: The operational context for the data exchange The stakeholders with an interest in the Use Case The information flows that must be supported by the data exchange The types of data required in the data exchange The Use Case is the foundation for identifying and specifying the standards required to support the data exchange and developing reference implementations and tools to ensure consistent and reliable adoption of the data exchange standards. 2.0 Overview and Scope The Initiative, Elements in Transition of Care, defines the electronic communication and data elements necessary for clinical information exchange to support transfers of care between providers and to inform patients. This Use Case addresses multiple scenarios. The first scenario focuses on the exchange of patient information between providers to accomplish a successful transition in care from one care environment to another. This includes transitions between acute, long-term care, nursing facility, rehabilitation, home healthcare, as well as discharges to home with follow up by primary care or specialty care provider(s). Transitions within the same care setting are not included in the scope of this Initiative. The Use Case includes referrals for the purpose of consultations. The second scenario focuses on the sharing of electronic clinical information from providers to their patients, including the data interchange required to support the needs of a patient -during these transitions of care. In this scenario, the patient has the ability to access and incorporate their available clinical information into their PHR. For both scenarios, it is important to have common transport standards for the secure and interoperable exchange of electronic health information in the context of Elements in Transition of Care. Successful outcomes and metrics of this Use Case include: [This needs to be updated, once the Success Metrics Committee has completed their work – HM] 1. The number of providers sharing Transitions of Care summaries 8/1/2011 6 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case 2. The number of organizations who have been certified to produce valid specifications (Software development/Tools organizations) 3. The time reduction for creation of new minimal unstructured summaries and structured summaries 4. Cost reduction for creation of core elements within Transitions of Care 5. Improvement in ability to achieve MU criteria 6. Process improvement efforts related to transfer patterns in a health information technology environment 7. Enhanced patient clinical outcomes secondary to self-awareness and involvement in their care 8. Identifying best practice IT standards to promote the interoperability of systems to successfully exchange clinical information safely and securely and to enable the recipient to view the clinical information in a human readable format. 2.1 In Scope Clinical Summary information and its basic dataset(s) for the Transition of Care to include the transfer of care and the exchange of clinical information between providers and between providers and patients All transitions between different care settings as discussed in the overview are to be supported within the scope of this initiative The requirements resulting from the initial ToC datasets provides the base for these additional care transitions. Transitions between different role groups within different sites of care. 2.2 Out of Scope The comprehensive EHR Financial Information, except for basic insurance information, will not be sent While Query Transactions are out of scope, consideration of metadata necessary to tag clinical summaries to support queries is within scope. Sharing of clinical summaries for other purposes; e.g., claims submission Transmission protocols are out of scope since the providers would not need to address the transport, though the system itself (outside the scope of a use case) would have to address the most efficient means of transport from sender to receiver. Defining or modifying existing clinical medicine practices 2.3 Background The Transition of Care Initiative is key to healthcare reform because its implementation will contribute to the overall cost savings within the US health system through enhanced care coordination, improved clinical outcomes and care efficiency, and decreased adverse events. Therefore this Transition of Care Initiative is aligned closely with the goals of Meaningful Use Stage 1 and anticipated Stage 2 as well as addressing various Prioritization Criteria as described next. Furthermore, the Transition of Care Initiative supports various evidenced based medicine and research initiatives including Comparative Effectiveness Research and other high priority research initiatives that align with the Nation’s agenda to improve the quality of care while reducing its costs.1 1 Comparative Effectiveness Research (CER) evaluates existing health care interventions to determine which work best for a particular patient as well as which treatments might have a deleterious effect and under what circumstances they are most likely to cause the greatest harm. According to the Institute of Medicine: “CER assists 8/1/2011 7 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case The Transition of Care Initiative addresses improvements in care coordination and patient engagement in their own healthcare, in order that the strong foundation of Meaningful Use Stages 1and 2 can be further strengthened with requirements for Meaningful Use Stage 3 that drive these improvements in care coordination and patient engagement. Improving the exchange of relevant clinical information through the specification of multi-role, multi-site datasets lays the foundation for supporting the longitudinal care plan which will cross multiple sites of care, unvolving multiple disciplines and require iterative exhanges among participants including the patient. The technical feasibility of this Initiative requires and supports information exchange. The Initiative specifically leverages existing interoperability standards; thus, many of the Healthcare Information Technology Standards Panel (HITSP) specifications (Appendix B) apply, as well as utilizing standards such as Health Level Seven (HL7) Continuity of Care Document (CCD and ASTM Continuity of Care Record (CCR)) developed by existing standard development organizations. This work assumes the use of the CCD for transitions of care. The Initiative supports data flow which can be tested as exhibited by the fact that NIST has current test scripts available. The Transition of Care Initiative is accountable by aligning Stakeholders’ readiness level of use as well as attempting to improve general Health IT usability. These Prioritization criteria coupled with existing relevant Use Cases (Appendix A) have rendered the basis for selection of the Transition of Care Initiative; thus, leveraging lessons learned that will be applied to the formulation of this Use Case. 2.4 Policy Issues The Use Case strives to address relevant and timely policy issues that will have downstream impacts on the US healthcare reform agenda; specifically as related to healthcare information technology. The Affordable Care Act mandates multiple pilots involving coordination of care, particularly at transitions. The primary policy issue at hand is the intention of the HIT Standards Committee to converge the clinical summary into a single standard. The Standards Committee has not confirmed that the HITSP C32/CCD will be the Base Standard. The current rule allows both CCD and CCR to be adopted. The CCR and CCD do not have sections for discharge diagnosis; this potentially could be included in a transition of care [summary]. The User Story and Activity Diagrams represent a generalized flow of information exchange, but do not represent infrastructure, architecture, or workflow requirements. They show what information needs to go from place A to place B to achieve a clinically sound transfer of care for the patient; however, they dictate neither the information content format, nor the specific transactions for the transfer of this information. It is left to policy makers to determine what requirements are applied to eligible providers for transition of care. However, the advantages of mandating a standard format for all transitions documents are worthy of additional investigation. Standardized format not only serves as a checklist for the sender, it makes it easier for the receiver to identify missing information. 2.5 Regulatory Issues Implementation of the Transitions of Care Initiative supports the following regulatory requirements: consumers, clinicians, purchasers, and policy makers in making informed decisions that will improve health care at both the individual and population levels." 8/1/2011 8 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case The Final Rule for Health Information Technology: Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology for Meaningful Use Stage 1 state the following: A. Initial Set of Standards, Implementation Specifications, and Certification for Electronic Health Record Technology (July 2010) identified the following standard for Engagement of Patients and Families in their Healthcare: (1) Electronic Copy of Health Information: Electronic copy of health information. Enable a user to create an electronic copy of a patient’s clinical information, including, at a minimum: diagnostic test results, problem list, medication list, and medication allergy list in: (1) Human readable format; and (2) On electronic media or through some other electronic means in accordance with: (i) The standard (and applicable implementation specifications) specified in §170.205(a)(1) or §170.205(a)(2); and (ii) For the following data elements the applicable standard must be used: (A) Problems. The standard specified in §170.207(a)(1) or, at a minimum, the version of the standard specified in §170.207(a)(2); (B) Laboratory test results. At a minimum, the version of the standard specified in §170.207(c); and (C) Medications. The standard specified in §170.207(d) Electronic Copy of *Discharge Instructions: Electronic copy of discharge instructions enable a user to create an electronic copy of the discharge instructions for a patient, in human readable format, at the time of discharge on electronic media or through some other electronic means. (2) *Electronic Copy of Discharge Instructions: Electronic copy of discharge instructions. Enable a user to create an electronic copy of the discharge instructions for a patient, in human readable format, at the time of discharge on electronic media or through some other electronic means. (3) Clinical Summaries for each Office Visit: Clinical summaries enable a user to provide clinical summaries to patients for each office visit that include, at a minimum: diagnostic test results, problem list, medication list, and medication allergy list. If the clinical summary is provided electronically it must be: (1) Provided in human readable format; and (2) Provided on electronic media or through some other electronic means in accordance with: (i) The standard (and applicable implementation specifications) specified in §170.205(a)(1) or §170.205(a)(2); and (ii) For the following data elements the applicable standard must be used: (1) Problems. The standard specified in §170.207(a) (1) or, at a minimum, the version of the standard specified in §170.207(a) (2); (2) Laboratory test results. At a minimum, the version of the standard specified in §170.207(c); and (3) Medications. The standard specified in §170.207(d). B. Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology (July, 2010) identified the following standard for Improvement in Care Coordination: (1) Enable a user to create an electronic copy of a patient’s clinical information, including, at a minimum, diagnostic test results, problem list, medication list, medication allergy list, and procedures: (I) In human readable format, and (ii) on electronic media or through some other electronic means in accordance with: (A) The standard (and applicable implementation specifications) specified in §170.205(a)(1) or §170.205(a)(2); and (B) For the following data elements the applicable standard must be used: 8/1/2011 9 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case (1) Problems. The standard specified in §170.207(a) (1) or, at a minimum, the version of the standard specified in §170.207(a) (2); (2) Procedures. The standard specified in §170.207(b) (1) or §170.207(b) (2); (3) Laboratory test results. At a minimum, the version of the standard specified in §170.207(c); and (4) Medications. The standard specified in §170.207(d). (2) Enable a user to create an electronic copy of a patient’s discharge summary in human readable format and on electronic media or through some other electronic means 2.6 Communities of Interest Communities of Interest are public and private stakeholders that are directly involved in the business process or are involved in the development and use of interoperable implementation guides and in their actual implementation. Communities of Interest may directly participate in the exchange; that is, they are business actors; or indirectly through the results of the improved business process. The following list of Communities of Interest and their definitions are for discussion purposes for Clinical Information Exchange. Member of Communities of Interest Patient Consumers Care Coordinators Clinicians Laboratories Pharmacies Provider 8/1/2011 Working Definition Members of the public who require healthcare services from ambulatory, emergency department, physician’s office, and/or the public health agency/department. Members of the public that include patients as well as caregivers, patient advocates, surrogates, family members, and other parties who may be acting for, or in support of, a patient receiving or potentially receiving healthcare services. Individuals who support clinicians in the management of health and disease conditions. These can include case managers and others. Healthcare providers with patient care responsibilities, including physicians, advanced practice nurses, physician assistants, nurses, psychologists, pharmacists, and other licensed and credentialed personnel involved in treating patients. A laboratory (often abbreviated lab) is a setting where specimens are sent for testing and analysis are resulted, and then results are communicated back to the requestor. The types of laboratories may include clinical/medical, and environmental, and may be both private and/or public Entities that exist that are experts on drug therapy and are the primary health professionals who optimize medication use to provide patients with positive health outcomes An individual clinician in a care delivery setting who requests, submits or accepts the transfer of the clinical 10 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Member of Communities of Interest Working Definition summary for the purposes of delivering care Provider Organizations Organizations that are engaged in or support the delivery of healthcare to include Hospitals, Ambulatory Centers and Provider Practices. IDNs, ACOs Standards Organizations Organizations whose purpose is to define, harmonize and integrate standards that will meet clinical, and business needs for sharing information among organizations and systems Federal Agencies Organizations within the federal government that deliver, regulate or provide funding for health and health care Electronic Health Record/Personal Health Record and HISP Vendors Vendors which provide clinicians and consumers specific EHR/PHR solutions such as software applications and software services. HISP organizations provide the technical capability to transmit the ToC messages across diverse EHR/PHR systems. These suppliers may include developers, providers, resellers, operators, and others who may provide these or similar capabilities. Table 1: Communities of Interest 3.0 Challenge Statement Meaningful Use Stage 1 and anticipated Stage 2 criteria require information to be exchanged in transitions of care. Implementers are often confused about how to adopt the specifications for exchange of the required data. The content of any exchange is only as good as its fidelity to source, assured identity, provenance, completeness, audit/traceability, full context, along with permissions and qualifications. Without ensuring these characteristics across information exchanges such that all are fully evident to the receiver (and ultimate user), no exchange is valid. Furthermore, this exchange is dependent on a secure, interoperable environment. Different transition scenarios may require different types of artifacts (e.g. a transition from inpatient to ambulatory may require a discharge summary; a transition from primary care provider to specialist may require a referral summary, etc). All of these artifacts should draw from a common framework. As part of that framework, we should allow for different data elements to be communicated as needed. In all cases, the ToC transaction should support existing clinical workflows, and data overloading the recipient clinician must be avoided. Ultimately, the data needs of the patient and caregivers should be considered because it is the providers, patient (and/or their legal representative) that are the recipient end users of the data. The challenge of data overload cuts both ways. It is inefficient for “senders” to collect information that provides no clinical benefit to the patient or guidance to the receiving clinician. It is also ineffient for “receivers” to wade through extraneous information to find the relevant data elements. This challenge can be met with two “filtering” processes, one for the sender and one for the receiver. 8/1/2011 11 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Among the deliverables of this initiative are datasets specific to sending and receiving sites that are purpose and patient specific and which contain only those data elements required by one of the receiving clinicians. No data elements other than these will be required in the CCD+. In this way, “senders” are protected from gathering and sending more information than is needed. The process by which the CCD is received requires a filtering capability. This specification of this capability is beyond the scope of this initiative but will be specified as a requirement for later development. Receivers will be able to “filter” the CCD+ to see only those elements that they want, even if more elements are included in the CCD+. As noted by the ToC WG, the exchange of clinical summaries is challenged by the selection of a single format for all transfers of care that does not support the various requirements for the data elements of different stakeholders, and diverse ToC circumstances. The current requirements that these all be communicated in either the CCD or CCR format may exclude data not supported by those standards. On the other hand, the use of a variety of formats for each different type of transfer of care would make it extremely difficult for systems to exchange and communicate the necessary data, and significantly delay this capability. We have chosen the CCD as the model for information exchange. The ToC WG identified a potential solution to the dilemma of restricted format needed to assure consistency and interoperability, and the variability of data elements required across such a diverse group of senders and receivers. They framed a potential response to this challenge and proposed to: Identify a “Core” data set that would be required in all ToC circumstances. Identify the kinds of data beyond this “Core” data set needed for various transfers of care circumstances by all the stakeholders. To define a uniform way of how to structure commonly used information. To provide a robust tool-set to aid in the development and validation of conforming implementations to support widespread adoption. The LCC SWG proposes to answer this challenge by creating a “Set of datasets” specifying the essential clinical content based on properties of the sending and receiveing sites, the purpose and characteristics of the transition and patient-specific charateristics. The “Set of datasets” is large but finite and able to be reconfigured as the requirements of clinical practice change and elements added or removed. The process by which this evolution is achieved is beyond the scope of this initiative but will need to be robust, broadly inclusive and responsive to changing clinical needs. Furthermore, each of these site and transition specific datasets can be futher customized with disease, medication and patient specific datasets. In this model, the CCD+ will have the following components 1. Core data elements common to all transitions of care 2. Site-specific data elements 3. Role-specific data elements required by designated receivers (MD, RN, Therapist, etc) 4. Transition specific elements based on the characteristics of the transition 5. Patient specific data elements. It is possible to build a “unique” CCD out of standardized components. The standardized components include: 1. core elements: present in all transitions documents i. ID 8/1/2011 12 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case ii. Demographics iii. Allergies iv. Active medications v. Contact information of the “sender” 2. Site-specific data elements i. Senders: identify critical elements that always apply when patients leave their site, as examples 1. ED: recent tests, tests pending, treatment, resonse, followup plan 2. Out patient testing: results of test/procedure, complications i. Receivers: elements they always need from this site of care 1. Details of follow-up plan 2. Name and contact information of the clinician responsible for managing each active problem addressed during the stay 3. Role-specific data elements ii. Physician 1. ED physician 2. PCP 3. Specialist 4. Rehab 5. Others iii. RN 1. ED 2. In patient 3. Wound care 4. Telemonitoring 5. Others iv. Case Manager v. Therapist 1. OT 2. PT 3. Speech vi. Administrative personnel vii. Technicians viii. Other 5. Transition-specific elements i. There are four broad types of transitions: 2x2 grid made up of the combinations of Elective/Urgent and Permanent/Temporary 1. Elective/Permanent: example-discharge summary from any site 2. Elective/Temporary: example-LTPAC to Out patient for testing, evaluation or procedure 3. Urgent/Temporary: example- LTPAC to ED for evaluation 4. Urgent/Permanent: example-admission to ACH in-patient unit after ED evaluation 6. Patient specific data elements i. Conditions: 1. CHF a. Target wgt 8/1/2011 13 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case b. Labs c. EF d. If EF< 40 if no betablocker, ACE-i/ARB, anticoag why not 2. Others 3. Medications a. Anticoagulation i. Agent ii. Duration iii. Route iv. Target v. Monitoring vi. Who manages vii. Data needed to safely prescribe next dose viii. Who to call with issues b. Others Standardized data sets currently exist or can be added using currently accepted vocabulary and definitions for any required data element. These component parts can be assembled to create a “unique” CCD for each patient, site and type of transfer. 4.0 Value Statement The standardized patient clinical summary will provide timely, accurate, and structured information at the point of care to the receiving provider as well as offering enhanced clinical information to the patient. The accuracy and appropriate amount (the data required for the care of the patient without data overload) of clinical information will ensure that clinicians provide high quality care and patients will now become more involved and be informed of their care overall leading to a patient centric approach and patient empowerment. Enhancing a patient’s ability to make well informed decisions about their healthcare can be supported by the patient having access to their health information. Defining the minimum data elements to be exchanged and mapping them to MU specified formats will facilitate this functionality becoming rapidly incorporated into certified EHR vendor offerings and better enable providers to use the specifications in a timely manner to exchange the required clinical data between care settings and with their patients. This initiative proposes to create these interoperable datasets to guide EHR vendors. 5.0 Use Case Assumptions Assumptions for this Use Case are the following: ToC to and from LTPAC are primarily “facility” to “facility” transfers, each involving the contributions of one or more providers to complete the required dataset.. This requires another level of organization that provides not only to capability of transferring and recei ving CCDs, but also the capabililty to construct them from inputs from the required participants. A provider is an individual clinician in a care delivery setting who submits or receives the transfer of the clinical message for the purposes of delivering care. A provider organization is 8/1/2011 14 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case engaged in or supports the delivery of healthcare and includes Hospitals, acute care facilities, rehabilitation, SN facilities, and Ambulatory facilities. The Transferring or Referring provider or Provider Organization has an EHR system or other software capable of producing a structured summary document using C32/CCD and/or CCR standards and properly coded data elements; and can be exchanged with another EHR system or PHR system. The EHR or PHR system is capable of ensuring that content of the Summary Record (as exchanged) maintains its fidelity to source, as well as assured identity, provenance, completeness, audit/traceability, full context, along with permissions and qualifications The HISP providing the technical exchange services has established network and policy infrastructure to enable consistent, appropriate, and accurate information exchange across clinical systems, EHRs PHRs, data repositories (if applicable) and locator services. This includes, but is not limited to: Methods to identify and authenticate users Methods to identify and determine providers of care Methods to enforce data access authorization policies Security and privacy policies, procedures and practices are commonly implemented to support acceptable levels of patient privacy and security; i.e. HIPAA, HITECH and EHR certification criteria The Patient has and uses a PHR The transmission of data may occur via HISPs or Health Information Exchanges as data may be transmitted to multiple EHRs, HIEs and providers Some exchanges may require HISP to HISP connectivity Appendix C provides more details on Privacy and Security assumptions. 6.0 Pre-Conditions Pre-conditions are those conditions that must exist for the implementation of the ToC interoperability Information Exchange. To ensure the Summary Record maintains its fidelity to source, assured identity, provenance, completeness, audit/traceability, full context, along with permissions and qualifications-both as a pre-condition of transmittal/disclosure (source/sending EHRs/PHRs) and of receipt (receiving EHRs/PHRs). PHR and EHR systems are in place. The Patient is registered in all systems. The Provider has treated the Patient or has been requested to treat the patient by another provider. Relevant clinical information will be exchanged which will include at a minimum “Core”, and may include “Variable” data. There are methods to ensure the veracity of data. Clinicians securely access clinical information through an EHR system. Patients may securely access clinical information through a PHR system. Appropriate standards protocols; patient identification methodology; consent; privacy and security procedures; coding, vocabulary and normalization standards have been agreed to by all relevant participants. 8/1/2011 15 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Legal and governance issues regarding data access authorizations, data governance, and data use are in effect. 7.0 Post Conditions Post Conditions are those conditions that exist after the Clinical Information Exchange. Clinical Information is successfully reported and electronically transmitted between Sending Provider to Receiving Provider or Patient PHR and (1) is accessible by the Receiving Provider/Patient through an EHR/PHR system and (2) is displayed in a human readable format. Clinical Information is accessible by the Electronic Health Record application. Clinical Information is accessible by the Personal Health Record application. 8.0 Actors and Roles This section describes the Business Actors that are participants in the information exchange requirements for each scenario. A Business Actor is an abstraction that is instantiated as an IT system application that a Stakeholder uses in the exchange of data needed to complete Use Case action(s); a Business Actor may be a Stakeholder. Furthermore, the systems perform specific roles in this Use Case as listed below: Actor Provider (Person) HISP Patient Provider Organization Caregivers System Electronic Health Record (EHR) System Health Information Service Provider Personal Health Record (PHR) System Electronic Health Record (EHR) System Personal Health Record (PHR) System Role Sender/Receiver or Source/Destination The “wire” across which the health information is sent from the sender to the receiver Sender/Receiver or Source/Destination Sender/Receiver or Source/Destination Sender/Receiver or Source/Destination Table 2: Actors and Roles of Use Case 8/1/2011 16 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case 9.0 Use Case Diagram The following diagram depicts the exchange to support the Elements in Transition of Care Use Case. 1. The ability of the Electronic Health Record System to send and/or receive Clinical Information through a HISP. 2. The ability of the Personal Health Record to send and/or receive Clinical Information through a HISP. Transition of Care Use Case Diagram Figure 1: Use Case Diagram 8/1/2011 17 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Transition of Care Context Diagram Send Clinical Summary, Consultation Request Summary Discharge Summary and/or Discharge Instruction st ue eq rge R n ha c tio lta r Dis u s o n d/ o C n ry, y a ma mar m s n um Su cal ge S ctio lini char nstru C I Patient ves Dis cei ry, Re ma e) op Sum f Sc o t ( Ou Rs H rE ide rov P tes da Up Transition Of Care Provider_1 Receive Clinical Summary and Consultation Summary Re Rece qu ive est C Sum linic a or mar l Sum Dis y D cha isc mary rge har , Co Ins ge S nsu tru um lta ctio ma tion ns ry a Sen nd dC / lini cal Sum Sum mar ma y an dC ry on su l t Provider_2 Figure 2: Context Diagram 8/1/2011 18 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case 10.0 Scenario 1: The Exchange of Clinical Summaries from Provider to Provider Introduction to Scenarios: As described in the Scope section, the Use Case has two scenarios: the first focuses on the perspective of provider to provider exchange of clinical summaries. The second focuses on the perspective of the providers sending these clinical summaries to patients and their PHR. Both scenarios share the same User Stories. However, the User Story in the first scenario is presented from the provider to provider perspective and the second scenario is presented from the provider to patient perspective. Thus both scenarios are based on the same User Stories and activities, just presented from the two perspectives. The actual instance of any of the User Stories and activities may include both perspectives. Assumptions: 1. The receiving facility may have provisionally accepted the patient for transfer or referral and wants the clinical summary, but this is not necessary for the sending facility to push the ToC information. 2. Informal negotiations between providers are out of scope and are not necessary to assure acceptance of transfer or referral. 3. Informal agreement to receive by other provider and by patient is necessary for actual transfer or referral of patient. Similarly informal agreement to receive the clinical information by the other provider and by the patient is necessary for information exchange to take place, as is traditional in current actual medical practice. 4. Scenario 1 does not describe transport or end user site activity but does include those data elements required by transport and end users for safe and efficient transfers. 5. The information exchange can be achieved with or without intermediaries. If the information is transferred via a HISP signed patient consent is not required. Using intermediaries such as an HIE requires signed patient consent in most states. Same assumptions apply to Scenario 1 and 2. 6. There are several rounds of “pre-transfer” information exchange which are out of scope including requests for bed availability, exchanges of “screening” information, final confirmation of bed availability and transfer time. 10.1 User Stories of Scenario 1 The User Stories illustrate a combination of events in the scenario flows which are described in further detail in the tables that follow. There are three high level user stories. These are: Acute Care Hospital Sites to Post Acute Care Sites (ACH to LTPAC), LTPAC Sites to ACH Sites (LTPAC to ACH) and LTPAC Sites to Other LTPAC Sites (LTPAC to LTPAC). In these scenarios, ACH Sites include the following: 1. In patient care units (In patient) 2. Emergency Departments (ED) 3. Out patient testing, treatment and procedure areas (Out patient) 8/1/2011 19 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case In these scenarios, LTPAC Sites include the following: 1. Long Term Acute Care Hospitals (LTAC) 2. In patient Rehabilitation Facilities (IRF) 3. Skilled Nursing and Extended Care Facilities (SNF/ECF) 4. Home Health Agencies (HHA) 5. Hospice Services at home or in a facility (Hospice) 6. Primary or Principal Care Physician and the Patient Centered Medical Home (PCP/PCMH) 7. Community Based Organizations providing Meals on Wheels, Respite, Homemaker services, etc (CBO) 8. The Patient and Family at Home (Pt/Fam) At different times, each ACH and LTPAC site can be a receiver of patients from other sites or a sender of patients to another site. These dual roles are displayed in the following grid which lists these sites as “senders” along the left hand column and “receivers” across the top row. Transitions to (Receivers) Transitions From (Senders) In Patient ED Out patient Services LTAC IRF SNF/ECF HHA Hospice PCP PCMH CBOs Patient/ Family In patient ED Out patient services LTAC IRF SNF/ECF HHA Hospice Ambulatory Care (PCP) CBOs Patient/Family 8/1/2011 20 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Of the 121 (11x11) potential transitions 48 are out of scope (in grey), 24 are low volume or low complexity leaving 49 clinically significant ACH to LTPAC, LTPAC to ACH, LTPAC to LTPAC or LTPAC to Patient transitions (circles). Transitions to (Receivers) Transitions From (Senders) In Patient ED Out patient V=H CI = H TV = H V=H CI = H TV = H V=H CI = H TV = H In patient ED Out patient services LTAC IRF SNF/ECF HHA Hospice Ambulatory Care (PCP) LTAC IRF SNF/ECF HHA Hospice Services V=H CI = H TV = H V=H CI = H TV = H V=H CI = H TV = H V=H CI = H TV = H V=L CI = H TV = H V=M CI = H TV = H V=H CI = H TV = H V=H CI = H TV = H V=H CI = H TV = H V=H CI = H TV = H V=M CI = H TV = H V=H CI = H TV = H V=H CI = H TV = H V=H CI = M TV = H V=H CI = M TV = H V=L CI = H TV = H V=H CI = H TV = H V=H CI = H TV = H V=H CI = M TV = H V=H CI = M TV = H V=H CI = H TV = H V=H CI = M TV = H V=H CI = M TV = H V=H CI = L TV = H V=H CI = M TV = H V=H CI = M TV = H V=H CI = M TV = H V=H CI = M TV = H V=H CI = L TV = H V=H CI = M TV = H V=H CI = L TV = H equals Priority PCP PCMH V=H CI = M TV = H V=H CI = L TV = H V=H CI = L TV = H V=H CI = M TV = H V=H CI = L TV = H V=H CI = L TV = M CBOs V=H CI = L TV = H V=H CI = M TV = H V=H CI = L TV = H V=H CI = M TV = H Patient/ Family V=H CI = M TV = H V=H CI = M TV = H V=H CI = M TV = H V=H CI = L TV = H V=H CI = L TV = H CBOs Patient/Family V= Volume CI= Clinical Instability Time-Value of information TV= Two Parameters Rated "H" Out of Scope There are other clinically significant transitions that are not included on this grid to other facility types such as Assisted Living Facilities, Specialty Hospitals and Psychiatric Facilities. In a later phase of this work, other senders and receivers will be added to this grid for creation of transition specific data sets. These priority transitions are nearly divided equally among the three high level user stories: ACH to LTPAC, LTPAC to ACH and LTPAC to LTPAC as indicated on the next figure. 8/1/2011 21 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Transitions to (Receivers) Transitions From (Senders) In Patient ED Out patient LTAC IRF SNF/ECF HHA Hospice Services PCP CBOs PCMH Patient/ Family In patient ED Out patient services LTAC IRF SNF/ECF HHA Hospice Ambulatory Care (PCP) CBOs Patient/Family LTPAC to ACH ACH to LTPAC LTPAC to LTPAC Priority Out of Scope These priority transition can be further divided in to the four basic types listed on page 13: Elective/Permanent: example- Discharge from any site Transfer from ED to LTPAC Elective/Temporary: example- LTPAC to Out patient Out patient to LTPAC Urgent/Temporary: example- LTPAC to ED Urgent/Permanent: example- LTPAC to In patient after ED evaluation These, too, are distributed but not equally among the three high level user stories. The data set associated with each of these transition is made up of a different combination of essential data elements thereby adding yet another level of complexity. 8/1/2011 22 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Transitions to (Receivers) Transitions From (Senders) In Patient ED Out patient LTAC IRF SNF/ECF HHA Hospice Services PCP CBOs PCMH Patient/ Family In patient ED Out patient services LTAC IRF SNF/ECF HHA Hospice Ambulatory Care (PCP) CBOs Patient/Family Elective/Permanent Elective/Temporary Urgent/Temporary Urgent/Permanet LTPAC to ACH ACH to LTPAC LTPAC to LTPAC Priority Out of Scope The final layer of complexity arises from the participation of different role groups in both sending and receiving sites. The specific participants also vary depending on the type of transition. The distribution of essential “receivers” within each of these transitions is displayed in the following grid. 8/1/2011 23 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Survey Respondants Transitions to (Receivers) by Role Group In Patient ED Out patient Essential Receivers Services Admin/Scheduler X X Care/Transition Manager X EMTs X X MD/NP X X X IRF SNF/ECF HHA X X X X X X X X X X X X OT X X X X PT X X X X X X X X X X X Social Worker X Speech Therapy X Technician Hospice PCP CBOs PCMH X RN X LTAC X Patient/ Family X X X X X X X X X X X X Although the matrix of sites, participants and types of transfers is very complex, fortunately data from IMPACT supports a far simpler taxonomy based on the type of transition and the roles of the participating receivers. NOTE:. Transfers of patients among ACH Units (ED to In patient, ICU to Floor, etc) are out of scope for this Use Case. However, the same data structure and principles used to identify essential clinical data elements in ACH-LTPAC transfer scenarios apply as well to intra-hospital transfers and inter-hospital transfers (ED to ED, In-patient to ED). The content of intra- and inter-hospital data sets can be constructed using the same processes employed here. User Story 1: The Exchange of Information to Support the Transfer of Patient Information from Acute Care Hospital Site of Care to Post Acute Site of Care (ACH to LTPAC) Actors: Actor Provider: Hospital In-patient, Out patient or ED Provider: LTAC, IRF, SNF, HHA, Hospice, PCMH, CBO *(Pt/Fam is discussed in the next section) Providers: multidisciplinary team members as needed to populate specific data elements 8/1/2011 Role Source Destination source 24 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Actor Role Providers: multidisciplinary team members at Destination receiving sites Table 3: Actors and Roles for Scenario 1 User Story 1 Setting 1: Hospital sites from where patient is discharged (sends discharge dataset to a PAC site of care). A patient is discharged from the hospital, out patient test area or ED. Discharge instructions are given to the patient by hospital personnel at the time of discharge. The instructions may be generic, patient specific, or disease specific depending on the facility’s practices and the patient’s needs. The patient acknowledges that he has received the instructions from the hospital personnel (verbally, in writing, or electronically). The acknowledgement triggers the physical discharge sequence of events and patient transport out of the facility. Upon discharge, the discharge summary is prepared within the Hospital EHR system. The attending physician of record (APoR) reviews the discharge summary (or instructions) and, once she has approved it, the discharge summary is included in the discharge packet. The discharge packet includes the discharge summary, discharge instructions and additional site, transition and patient specific data elements). This is sent to the Post Acute Care Team This information is sent with the patient or prior to the patient’s arrival at the PAC site to assure that the essential clinical data required to assure a safe and efficient transition of care is available to the receiving team in a timely manner. The summary may arrive in the PCP’s EHR system even before the patient has left the hospital. A copy of the message may be retained in the hospital EHR per the hospital’s policies and workflow rules. Audit logs of the exchange are retained according to the hospitals, PCP’s, and any intermediaries’ policies, procedures, and agreements. Setting 2: Patient's PCP or Care Team (receives discharge summary from Hospital or ED clinical system). Discharge summary/instructions are received into the PCP practice’s EHR system. Patient generally will be known in the EHR system in which case an automated EHR match may occur). Discharge summaries/instructions that are not automatically matched to a patient are reconciled manually, which may include the process of creating a new patient record and registering the patient. Once the discharge summary/instructions have become part of the PCP’s EHR system, additional practice variable activities may occur: new tasks may be directed to a front desk staff EHR work queue, as well as to additional staff EHR work queues as appropriate to the practice workflows. Follow-up/plan of care is managed according to established PCP workflow. For example, upon receiving notification of the patient’s status, the care manager is now aware that the patient has been discharged from the hospital. The Care Manager may be aware that the patient becomes confused when medications are altered and calls the patient to ensure the patient is taking the correct medications post discharge and is following the discharge instructions. The PCP may review and promote into the EHR the newly reconciled active medications, updated problem lists, new procedures and other discrete data elements. The hospital (or ED) discharge summary/instructions are retained in its entirety as a permanent part of the patient’s record. *User Story 1 could also be applied to a specialist sending reports back to PCP for follow-up post op or post discharge. 8/1/2011 25 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case User Story 2: Closed Loop Referral Actors Actor Provider; PCP's EHR System Provider; Specialist's EHR System Role Referral Source Referral Destination Table 4: Actors and Roles for Scenario 1 User Story 2 Setting 1: PCP's office (sends consultation request clinical summary to specialist). A PCP is in the middle of an encounter (office visit) with a patient and determines that the patient needs to be referred to a specialist. The PCP is documenting the encounter in the EHR and within the EHR prepares the consultation request clinical summary for the specialist. The message is addressed to the appropriate specialist, specialty or provider organization and is sent to the specialist’s EHR system. In all cases the message will include the “Core” data and ideally will also include selective “Pertinent” data. Setting 2: Specialist's office (receives referral request clinical summary from PCP; send consultation summary to PCP). The consultation request clinical summary is processed according to the specific context of the referral. In accordance with practice policies and workflow the specialist reviews the document and orders any additional tests to be performed for the patient prior to the office visit. Discrete data elements from within the summary may be promoted to the specialist’s EHR system (date time and source stamped). When the patient arrives at the specialist’s office he is registered in accordance with practice policies and workflow. The specialist documents the encounter in the EHR system and prepares the consultation summary for the PCP. Once the consultation summary is prepared, it is addressed and sent to the PCP’s EHR system. A copy of the message is retained in the specialist’s EHR system *User Story 2 could also be applied to a specialist sending reports back to PCP for follow-up post op or post discharge. Return to Setting 1: PCP’s office The consultation summary is received into the PCP practices’ EHR system. Once the consultation summary is received into the EHR system, additional practice variable activities may occur: tasks can be directed to a front desk staff EHR system work queue for appropriate distribution to additional staff’s EHR system work queues, as appropriate to the practice workflows. For example, the front desk staff may schedule a follow-up visit with the patient and alert the PCP of the availability of the consultation summary. If the patient has an assigned Care Manager who follows the patient at an advanced practice care facility (such as a Patient-Centered Medical Home), review alerts may be sent to both the PCP and the Care Manager for appropriate compliance planning. Discrete data elements from within the consultation summary may be promoted to the PCP’s EHR system. In accordance with practice policies and EHR functionality, the PCP may review and promote to the EHR the specialist-reconciled active medication and problem lists, any new procedures may be accepted into the EHR, and any other new discrete data elements may become part the of the patient’s EHR 9all date/time/source stamped). The consultation summary may be retained in its entirety as a permanent part of the patient’s EHR record. User Story 3: Complex Series of Care Transactions 8/1/2011 26 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Setting: Emergency Department Activity: A patient is transported to the ED from home in a semi-comatose condition. Their significant other has printed data from the patient’s PHR and has given that to the EMS to give to the ED doctor. The patient is admitted to the ED. The ED EHR system receives the patient summary from the patient’s PCP’s EHR system. The ED physician determines that the patient needs to be admitted to the hospital. The patient is admitted to the hospital’s critical care unit. As the ED and the Hospital share the same EHR system the data, once entered into the system, is available to all appropriate end users caring for the patient. Summary Contents: Both basic standard dataset and patient summary message context relevant dataset-----APPLIES TO ALL Transitions of Care (Basic data set and pertinent data set to not data overload the recipient clinicians). Message should always include Core basic dataset: Demographic information, active medication list (with doses and sig), allergy list, problem list, etc. Summary contains variable dataset relevant to the context: Examples: Recent results, vitals, etc. Setting: Hospital Activity: A patient is cared for in a critical care unit. All treating clinicians have access to the information in the Hospital EHR system. The patient’s significant other, who is the patient’s Durable Power of Attorney for Healthcare (DPOA-HC), is staying with the patient in the hospital. The patient’s DPOA-HC requests that copies of changes to patient’s orders be sent directly from the hospital EHR to the patient’s PHR so that he/she can monitor the patient’s care. After several days in the intensive care unit it is determined that the patient would benefit from intensive rehabilitation that is not available at the hospital. The attending physician arranges a discharge from the hospital and transfer for the patient to a Rehabilitation Facility. In accordance with the hospital’s policies and workflow a discharge summary & instructions are prepared by the hospital EHR. The discharge summary and instructions, including recommendations for continuation of open orders, are sent to the Rehab facility EHR. The hospital EHR sends patient’s PCP’s EHR a copy of discharge summary/instructions. Upon discharge from hospital, the patient is transferred to a rehabilitation facility. The TOC discharge information is transferred via a HISP to the recipient facility prior to the patient leaving the hospital. Summary Contents: Both basic standard dataset and Discharge context relevant dataset Summary should always include Core basic dataset: Demographic information, active reconciled medication list (with doses and sig), allergy list, problem list, reason for admission, follow up/discharge instructions etc. Summary contains variable dataset relevant to the hospitalization (selected by the clinician who prepared the discharge message): Examples: 8/1/2011 27 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case o Procedures during hospitalization o Relevant results, reports o Wound care (if applicable) o Speech, Occupational & Physical Therapy orders and Activities of Daily Living (ADL) evaluations o Etc. Setting: Rehabilitation Facility Activity: The hospital discharge summary/instructions are received in the Rehab facility's EHR system. When the patient arrives she is admitted and the EHR is updated. The EHR system provides the patient information for review by the hospital personnel that will be caring for the patient. Once reviewed and approved by the clinicians in accordance with the facility’s policies, protocols and workflows, the information is available to all of the rehab staff that will be caring for the patient. The patient’s PHR receives copies of rehab case review notes and ADL evaluations so that the DPOA-HC can actively monitor the patient’s progress and assist in planning patient’s discharge destination post-rehab. Upon completion of the rehabilitation, the patient is discharged to home/PCP. At this point in time the patient’s PCP receives a discharge summary ToC document at the time the patient is being discharged from this facility prior to the patient physically being out the door. – see User Story 1. Summary Contents: Both basic standard dataset and Discharge context relevant dataset Summary should always include Core basic dataset: Demographic information, active reconciled medication list (with doses and sig), allergy list, problem list, reason for admission, The Summary contains variable dataset relevant to the rehab care plan. Examples might include: o Therapy orders o ADL scores 10.1.1 Base Flow of Scenario 1 User Story 1: The Exchange of Discharge Summary to Support the Transfer of Patient Information from One Provider to another Provider. Step # 1 Actor Provider 2 Hospital EHR System 3 PCP EHR System or other Provider EHR System Provider 4 8/1/2011 Event/Description Trigger Generation of Discharge Summary for Patient A Send Discharge summary to PCP's EHR System or other Provider EHR System Receive Discharge Summary Inputs START Outputs Discharge Instructions Discharge Instructions Discharge Instructions Discharge Instructions Discharge Instructions Trigger Generation of Discharge Summary for Discharge Summary Discharge Summary 28 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Step # Actor Event/Description Inputs Outputs Patient A (includes Discharge Instructions) 5 Hospital EHR System Send Discharge summary to Discharge Discharge PCP's EHR System or other Summary Summary Provider /Organization 6 PCP EHR System or Receive Discharge Summary Discharge Discharge other Provider EHR Summary Summary System 7 Provider View Discharge Discharge END Summary/Instructions Summary Table 5: Base Flow of Scenario 1 User Story 1 User Story 2: The Exchange of Clinical Summaries to Support the Closed Loop Referral of a Patient from One Provider to Another Step # 1 Actor Provider Event/Description Trigger Generation of Consultation Request Clinical Summary for Patient A Inputs START 2 PCP EHR System 3 Specialist EHR System 4 Provider 5 Provider Consultation Request Clinical Summary Consultation Request Clinical Summary Consultation Request Clinical Summary START 6 Specialist EHR System 7 PCP EHR System 8 Provider Send Consultation Request Clinical Summary to specialist's EHR System Receive Consultation Request Clinical Summary from PCP's EHR System View Consultation Request Clinical Summary in specialist's EHR System Trigger Generation of Consultation Summary for patient A Send Consultation Summary to PCP's EHR System Receive Consultation Summary from specialist's EHR System View Consultation Summary in PCP's EHR System Consultation Summary Consultation Summary Consultation Summary Outputs Generated Consultation Request Clinical Summary Consultation Request Clinical Summary Consultation Request Clinical Summary END Generated Consultation Summary Consultation Summary Consultation Summary END Table 6: Base flow of Scenario 1 User Story 2 User Story 3: Complex Series of Care Transitions (Note: Events of this User Story are reflected in the Simple ToC User Story) 8/1/2011 29 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case 10.1.2 Activity Diagrams for Scenario 1 The following are the Activity Diagrams to support the events in section 10.1.1. User Story 1: The Exchange of Information to Support the Transfer of Patient Information from a One Provider to Another. Figure 3: Activity Diagram of Scenario 1 User Story 1 8/1/2011 30 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case User Story 2: The Exchange of Clinical Summaries to Support the Closed Loop Referral of a Patient from a One Provider to Another. Figure 4: Activity Diagram of Scenario 1 User Story 2 8/1/2011 31 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case 10.2 Functional Requirements of Scenario 1 10.2.1 Information Exchange Requirements of Scenario 1 Initiating System Information Interchange Requirement Content Hospital/ED EHR Send Discharge Summary Receives System (A.XFER.1)2 (A.XFER.2) PCP EHR System Send Consultation Request Receives (A.XFER.1) Clinical Summary (A.XFER.2) Specialist EHR Send Consultation Receives System (A.XFER.1) Summary (A.XFER.2) And or Procedure/operative note Receiving/Responding System PCP EHR System Specialist EHR System PCP EHR System Table 7: Information Exchange Requirements of Scenario 1 10.2.2 System Requirements of Scenario 1 System Requirement Name Display Discharge Summary Display Consultation Request Clinical Summary Display Consultation Summary System PCP EHR System Specialist EHR System PCP EHR System Table 8: System Requirements of Scenario 1 2 This identifier comes from the ONC SI-UC-Simplification spreadsheet (see References) 8/1/2011 32 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case 10.3 Sequence Diagrams of Scenario 1 The following sequence diagrams describe the messages and order of messages. User Story 1: The Exchange of Information to Support the Transfer of Patient Information from a One Provider to Another. Figure 5: Sequence Diagram of Scenario 1 User Story 1 8/1/2011 33 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case User Story 2: The Exchange of Clinical Summaries to Support the Closed Loop Referral of a Patient from a One Provider to Another. Figure 6: Sequence Diagram of Scenario 1 User Story 2 *********PLEASE NOTE: The downloading of Patient Information to the PHR is included in Scenario 2: Exchange of Clinical Summaries between Provider to Patient. *********** 8/1/2011 34 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case 11.0 Scenario 2: The Exchange of Clinical Summaries between Provider to Patient in Support of Transitions of Care 11.1 User Stories of Scenario 2 The visuals below depict a combination of all events described in the scenario flows which are described in further detail in the tables that follow. (Refer to sections highlighted in red and italicized, which are the focus of this scenario) Assumption: Scenario 2 does not describe transport or end user site activity. User Story 1: The Exchange of Discharge Instructions and Discharge Summary between a Provider and Patient to Support the Transfer of a Patient from One Care Setting to Another. Actors Actor Provider: Any Provider EHR System Patient: The Patient's PHR System or Patient Portal Role Source Destination Table 9: Actors and Roles of Scenario 2 User Story 1 Setting 1: Hospital or ED from where patient is discharged (sends discharge instructions to patient). A patient is discharged from the hospital or ED. Discharge instructions are given to the patient by his hospital personnel at the time of discharge. The instructions may be generic, patient specific, or disease specific depending on the facility’s practices and the patient’s needs. The patient acknowledges that he has received the instructions from the hospital personnel (verbally, in writing, and/or electronically). The acknowledgement triggers the physical discharge sequence of events and patient transport out of the facility. The discharge instructions are sent to the patient’s PHR and to the patient's primary care physician (PCP) or Care Team (as the instructions may contain information necessary for the PCP or Care Team to follow up with the patient before the discharge summary is available). Upon discharge, the discharge summary is prepared within the Hospital EHR system. The attending physician of record (APoR) reviews the discharge summary and, once approved, the discharge summary is sent to the PCP. The summary may arrive in the PCP’s EHR system even before the patient has left the hospital. A copy of the message may be retained in the hospital EHR per the hospital’s policies and workflow rules. The discharge summary, or portions thereof, may also be sent to the patient’s PHR system. NOTE: The discharge instructions described above are also part of the discharge summary. Depending on the workflow, and the policies at the hospital or ED, the patient and patient’s PHR may receive only the discharge instructions at discharge. The discharge summary may be provided later upon request and within 36 hours of discharge. Audit logs of the exchange are retained according to the hospital’s PHR systems, and any intermediaries’ policies, procedures, and agreements. Setting 2: Patient 8/1/2011 35 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case The patient discharge instructions and discharge summary are received by the patient’s PHR system. Depending on the specific PHR application, the patient or home health agency (HHA) receives a notification to access and review the PHR. The patient (or patient’s authorized proxy) accesses the PHR and may review the patient discharge instructions. Again, depending on the PHR system's functionality the patient or proxy may be able to select sections within the discharge instructions (discrete data elements) to automatically populate the appropriate fields in the PHR. For example, the newly reconciled medication list is selected to upload to the active medication list section of the PHR and the patient uploads any new problems to the problem list. Some information may be selected to initiate the agency workflow process. The PHR system may also receive the discharge summary. In that case please see the "Closed Loop Referral" User Story about handling the receipt of a medical summary in the PHR system. User Story 2: The Exchange of Clinical Summaries between Provider and Patients to Support the Closed-loop Transfer of a Patient from One Care Setting to Another Consultation Referral. Actors Actor Provider: Any Provider EHR System Patient: The Patient's PHR System or Patient Portal Role Source Destination Table 10: Actors and Roles of Scenario 2 User Story 2 Setting 1: PCP’s office Activity: Primary Care Physician is in the middle of an encounter (office visit) with a patient and determines that the patient needs to be referred to a specialist. The PCP is documenting the encounter in the EHR and within the EHR prepares the consultation request clinical summary to the specialist. The summary is addressed to the appropriate specialist, specialty or provider organization and is sent to the specialist’s EHR system. The consultation request, clinical summary, or portions thereof may also be sent to the patient’s PHR system. Setting 2: Specialist’s office Activity: The consultation request clinical summary is processed according to the specific context of the referral. In accordance with practice policies and workflow the specialist reviews the document and orders any additional tests to be performed for the patient prior to the office visit. Discrete data elements from within the summary may be promoted to the specialist’s EHR system, date/time/source stamped. When the patient arrives at the specialist’s office he is registered in accordance with practice policies and workflow. The specialist documents the encounter in the EHR system and prepares the consultation summary to the PCP. Once the consultation summary is prepared it is addressed and is sent to the PCP’s EHR system. A copy of the summary is retained in the specialist’s EHR system. The consultation summary will include “Core” data, and may include “variable” data. The consultation summary may also be sent to the patient’s PHR System. 8/1/2011 36 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case NOTE: The return to PCP office is only needed in Scenario 1 for the receiving of the consultation summary by the PCP. In Scenario 2 there is not provider/patient exchange of information as part of Transition of Care in the return to Setting 1. Setting 3: Patient Activity: "Consultation summary" is received by the patient’s PHR system. Depending on the specific PHR system, the patient may receive a notification to access his PHR as there is new information available. The patient (or the patient’s authorized proxy) accesses the PHR and may review the consultation request clinical summary. The patient (or his proxy) may respond with questions. Again, depending on the PHR system's functionality the patient may be able to select sections of the consultation request clinical summary (that are discrete data elements) to automatically populate the appropriate fields in the PHR. For example, the patient may upload any new problems to the problem list. Other PHR systems may have “all or none” functionality allowing the patient to simply determine if he would like to retain or delete the consultation request clinical summary in the PHR system. 11.1.1 Base Flow of Scenario 2 User Story 1: The Exchange of Discharge Instructions between Provider and Patient to Support the Transfer of a Patient from One Care Setting to Another. Step # 1 Actor Provider 2 EHR System 3 PHR System 4 EHR System 5 PHR System Event/Description Order/Address/Request: Discharge Summary and Discharge Instructions to Patient A in EHR (and has been acknowledged by patient) Generate and Send: Discharge Instructions to PHR Receive: Discharge Instructions in PHR Generate and Send: Discharge Summary to PHR Receive: Discharge Summary in PHR Inputs START Outputs Discharge Summary and Discharge Instruction Request Discharge Instructions Request Discharge Instructions Discharge Summary Request Discharge Summary Discharge Instructions Discharge Instructions Discharge Summary END Table 11: Base Flow of Scenario 2 User Story 1 User Story 2: The Exchange of Clinical Summaries between Provider and Patients to Support the Closed-loop Consultation Referral. Step # 1 Actor Provider (PCP) 2 EHR System 8/1/2011 Event/Description Order/Address/Request: Consultation request while meeting with patient Generate and Send: Consultation request summary Inputs START Initiated Consultation Request Summary Outputs Initiated Consultation Request Consultation Request Summary 37 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Step # Actor Event/Description Inputs Outputs 3 PHR System Receive: Consultation Consultation Consultation Request Summary in PHR Request Request Summary Summary Note: rows 4-6 will occur for any delivery of a Clinical Summary 4 Provider Order/Address/Request: START Initiated Clinical Clinical Summary including Summary specialist’s summary Request 5 EHR System Generate and Send: Clinical Initiated Clinical Clinical Summary Summary details Summary Request 6 PHR System Receive: Clinical Summary in Clinical Summary Clinical Summary PHR Table 12: Base Flow of Scenario 2 User Story 2 8/1/2011 38 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case 11.1.2 Activity Diagrams of Scenario 2 The following are the Activity Diagrams that support the events in section 11.1.1. User Story 1: The Exchange of Discharge Instructions and a Discharge Summary between a Provider and a Patient to Support the Transfer of a Patient from One Care Setting to Another. Figure 7: Activity Diagram of Scenario 2 User Story 1 8/1/2011 39 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case User Story 2: The Exchange of Clinical Summaries between Provider and Patients to Support the Closed-loop Consultation Referral. Figure 8: Activity Diagram for Scenario 2 User Story 2 8/1/2011 40 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case 11.2 Functional Requirements of Scenario 2 11.2.1 Informational Interchange Requirements of Scenario 2 Initiating Information Interchange System Requirement Name Receiving/Responding System Electronic Health Record System Electronic Health Record System Send (A.XFER.1)3 Discharge Summary Receives (A.XFER.2) Personal Health Record System Send (A.XFER.1) Discharge Instructions Receives (A.XFER.2) Personal Health Record System Electronic Health Record System Electronic Health Record System Send (A.XFER.1) Consultation Request Summary Receives (A.XFER.2) Personal Health Record System Send (A.XFER.1) Clinical Summary Receives (A.XFER.2) Personal Health Record System Table 13: Informational Exchange Requirements of Scenario 2 User Story 1 11.2.2 System Requirements of Scenario 2 System Requirement Name Display Discharge Summary Display Discharge Instructions System Personal Health Record System Personal Health Record System Table 14: System Requirements of Scenario 2 3 This identifier comes from the ONC SI-UC-Simplification spreadsheet (see References) 8/1/2011 41 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case 11.3 Sequence Diagrams of Scenario 2 The following sequence diagrams describe the messages and order of messages. User Story 1: The Exchange of Discharge Instructions and a Discharge Summary between a Provider and a Patient to Support the Transfer of a Patient from One Care Setting to Another. Figure 9: Sequence Diagram for Scenario 2 User Story 1 8/1/2011 42 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case User Story 2: The Exchange of Clinical Summaries between Provider and Patients to Support the Closed-loop Consultation Referral. Figure 10: Sequence Diagram of Scenario 2 User Story 2 8/1/2011 43 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case 12.0 Issues and Obstacles In general, the absence of the pre-conditions described in the previous section presents obstacles to implementation of the Use Case. Additional obstacles are provided below: Variations in local, state and national security and privacy regulations, and other pertinent laws. o There are regulations concerning the storage, transmission, or destruction of electronic health information. These regulations are inconsistent across federal, state, and local jurisdictions. Lack of harmonization among data interoperability standards including vocabulary and other messaging standards. o Without consistent standards, the viewing, accessing, or transmitting of electronic health information may be inhibited. Certainly the eventual ability to seamlessly upload discrete data from one EHR system to another would be inhibited Incomplete and or inaccurate data or proprietary-formatted information prevents information exchange activities; Consulting Provider may not be able to receive the data A lack of EHR and PHR adoption A lack of a sustainable business model and pervasive infrastructure to enable electronic data exchange. Policies do not exist for a patient’s ability to understand and control clinical information when using a PHR. [We had addressed this and commented that it is out of scope and would be up to the PHR edge vendor system] There is limited integration of PHRs with provider workflows. State Laws regarding laboratory results. 13.0 Dataset Considerations The following summaries are described in the previous user stories: Discharge Summary Discharge Instructions Clinical Summary including Consultation Request Clinical Summary The Sub-Workgroup did not describe standard content of summaries such as: Patient identity [This was included in the Core data set under patient demographics] Data to insure transport of the content Provider Directories Security, auditing and other policy content Other procedural overhead, etc. The following tables describe the sections and data expected to be found in these clinical summaries: 8/1/2011 44 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case All of the data in the tables may not be clinically relevant in all situations. Data that is not clinically relevant to a particular ToC circumstance would simply not be “selected” by the sending provider – This is assuming that this would be a GUI design element in EHR systems upon which EHR vendors would compete pertaining to this functionality. Some clinical situations may require additional data not included in the tables [e.g. currently not captured in EHR systems or if captured, not captured as discrete data, but captured as free text] Meaningful Use may only require a subset of the data Dataset for Discharge Instructions: Discharge Instructions always includes standard basic dataset: Demographic information, active medication list (with doses and sig), allergy list, problem list. Discharge Instructions contains also dataset relevant to the discharge summary/discharge instructions context: This will depend on what the sending clinician deems as relevant and may include: Follow up/plan of care (e.g., CCD/83 Plan of Care (What patient can do)): Prospective sections (Treatment Plan), treatments, diet, activities, alerts for conditions, future visits (may include several depending on condition) including appointment established. Patient education and information on medication (tied to alerts), disease process, wound care, condition based special considerations, etc.) etc. Message contains variable dataset relevant to the hospitalization (selected by the clinician who prepared the discharge summary): Examples o Procedures during hospitalization o Selected medications administered during hospitalization o Selected vital signs o Emergency contact information o Relevant results, reports o Wound care (if applicable) o Etc. Ref.4 T.CC.1 Section Personal Information T.CC.5 Allergies and Other Adverse Reactions T.CC.6 Problem List 4 Content Name, DOB, Next of Kin, Address, Phone Number, Gender, Marital Status, Religion, Race, Ethnicity Allergy Type; and Date Substance intolerance Associated Adverse Events Current Diseases & Conditions monitored for the patient and Additional Notes List of allergies which might include allergy to what (e.g., medication. food, environment). Sensitivity. Past and those that have arisen List of problems/complaints (what was diagnosis, complaint This identifier comes from ONC-SI-UC Simplification spreadsheet. See references. 8/1/2011 45 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Ref.4 Section Content Additional Notes status and/or descriptor of problem/complaints, symptoms). How do these problems/complaints impact interventions, orders or instructions. T.CC.16 Hospital Medications names, doses, Include the reconciled active Discharge frequency, route ordered for medications including time of Medications the patient for after discharge. last dose and whether patient was sent with samples of the medication(s). NOTES. Instructions may be more detailed if sent to another provider. T.CC.18 Advance Yes/no, whether or not these Yes/No - Target is to trigger a Directives exist conversation. Whether a Healthcare Proxy has been invoked T.CC.20 Immunizations Immunizations name, dose, Comprehensive list of immunizations route, date administered to received during the hospital stay the patient T.CC.21 Plan of Care Proposed interventions and Subsections include the following (1-7) procedures for patient 1. Goals. 2. Results yet to be received and procedures to be followed up on. 3. Active and scheduled interventions and orders (short term direct instructions [e.g. Vital sign checks, labs, etc.] - in the long run as validated by the patient and those contributed by the patient/caregiver). 4. Education Resources/Materials Patient education needed. To include classes, educational sessions, and printed materials along with steps to a specific need. 5a. Diet and Diet/Fluid Restrictions: All instructions that describe the expected diet. b. Restrictions: List of limitations being placed on the diet 6a. Fluids Management (C/N): All instructions that describe the expected fluids and method of administration. b. Restrictions: List of limitations being placed on fluids 8/1/2011 46 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Ref.4 Section Content Additional Notes 7. Activity/Exercise NOTES. Instructions may be more detailed if sent to another provider. - Yes/No - has the discharge instruction been reviewed with the patient? - Yes/No - has the discharge instruction been accepted by the patient, if no then how addressed T.CC.22 Medical Implanted and External Medical List of devices and where the Equipment Devices; Dates device is to be includes secured/prescribed/embedded. assistive Duration of medical devices. devices and is History of devices (recalls, S/N, related to etc.) functional Includes reading glasses, hearing status aids, dental appliances, etc. ADDED Patient Risks Falls, Elopement, etc Strategies to mitigate patient risks ADDED Risks to Others Contagion, Violent behavior Isolation Requirements, etc ADDED Electronic Links Links to provider or other computer applications for patient results, summaries, etc. ADDED Patient List of facility dependent patient Oriented oriented items (e.g., pain scale at Embarkation discharge, last ECG, etc.) Checklist ADDED Functional End state/goal expressed/Projected Status (O/N) change in functional status (will relate to the goals identified) Table 15: Dataset for Discharge Instructions Dataset for Discharge Summary: Discharge Summary Contents: Both basic standard dataset and discharge context relevant dataset are determined by the discharging provider organization in accordance with the discharging provider, local policy, regulations and law. The receiving provider through its EHR system may determine how to incorporate and present the Discharge Summary. Notwithstanding the Discharge Summary should always include the core dataset. At discharge the summary might include content for the Discharge Instruction as well as Discharge Summary. Discharge Summary content includes: Demographic information, active reconciled medication list (with doses and sig), allergy list, problem list, and reason for admission. Message contains variable dataset relevant to the hospitalization (selected by the clinician who prepared the discharge message). Examples: 8/1/2011 47 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Procedures during hospitalization Relevant results, reports Wound care (if applicable) Etc. Hospital and ED discharge is also the focus of several other efforts including individuals and institutions involved in ToC. For instance, the HIE Challenge Grants, Improving Massachusetts Post-Acute Care Transfers (IMPACT). Input was provided by Keith Boone; (http://motorcycleguy.blogspot.com/2010/11/circle-never-ends.html). Consideration was given to HITSP C32 Version 2.5, Meaningful Use EHR certification requirement and CDA Consolidation. Along with input from the Use Case Simplification and Discharge Instruction Sub Workgroups the following recommended sections and data are included in the Discharge Summary. The sections with a are also found in the HITSP C48 Encounter Document Using IHE Medical Summary (XDS-MS) Component. Ref. 5 T.CC.1 Section Personal Information T.CC.2 Contact Information Insurance Information T.CC.3 T.CC.4 T.CC.5 T.CC.6 T.CC.7 T.CC.8 5 Healthcare Provider Allergies and Other Adverse Reactions Problem List Active Problems (R/N)/Chief Complaint (overriding problem at the time of discharge) chronic illness and congenital problems History of Past Illness Chief Complaint Content Additional Notes Name, DOB, Healthcare Power of Attorney, Address, Phone Number, Gender, Marital Status, Religion, Race, Ethnicity Contact Name, Contact Number Insurance Name, Phone #, Group #, Type, Member #, Subscriber Name, Financial responsibility Provider Name, Address, Phone Number, Type Allergy Type; and Date Current Diseases & Conditions monitored for the patient and status List of allergies which might include allergy to what (e.g., medication. food, environment) List of problems/complaints (what was diagnosis, complaint and/or descriptor of problem/complaints, symptoms). Diseases & Conditions Patient has suffered in the past Description of Patient's This identifier comes from the ONC SI-UC-Simplification spreadsheet (see References) 8/1/2011 48 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Ref. 5 Section Content Additional Notes (see change in Complaint (narrative) T.CC.6 Problem List) T.CC.9 Reason for Reason Patient is being Transfer referred T.CC.10 History of Sequence of events proceeding Present patient's disease/condition Illness T.CC.11 List of Surgeries List of types of surgeries and dates T.CC.12 Hospital List of Hospital Diagnosis and Admission dates Diagnosis T.CC.13 Discharge Conditions/Diseases identified during hospital stay and dates Diagnosis T.CC.14 Medications List of Current Medication Include the reconciled active Names ; date, route, dose, medications frequency T.CC.15 Admission List of historical medication Medications names, dose, route, frequency, date patient has taken History previously T.CC.16 Hospital Medications names, doses, Discharge frequency, route ordered for the patient for after discharge Medications T.CC.17 Medications Medications administered to patient during the course of an Administered encounter; name, dose, route, frequency T.CC.18 Advance A summary of patient's Yes/No, if Yes date of last known expectations for care Yes/No if Physician Orders for Directives Life-Sustaining Treatment (POLST) form returned Where is last known version/original is located T.CC.19 Pregnancy Pregnant, Yes/NO T.CC.20 Immunizations Immunizations name, dose, Comprehensive list of immunizations route, date administered to received during the hospital stay. the patient T.CC.21 Physical Physical Findings of the Patient; VS, Biometrics, Review of Examination Systems T.CC.22 Vital Signs Patient's Vital Signs ; Heart Including Pain Scale Assessment, Vital Signs (R/N) rate, Resp Rate, Pulse Ox, Smoking Status including Pain Temp, B/P, Pain 8/1/2011 49 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Ref. 5 Section Content Additional Notes Scale Assessment, Smoking Status T.CC.23 Review of Functions of various body systems; Neuro, Derm, GI, GU, Systems Cardiac, Pulmonary, MS, Repro, Nervous, Endocrine T.CC.24 Hospital Course Sequence of (name, diagnosis associated with) events and dates from admission to discharge of hospital stay T.CC.25 Diagnostic Results and dates of Diagnostic Corresponding results to the scheduled Procedures procedures and interventions Results T.CC.26 Assessment and Assessment of patients Plan conditions and expectations/goals of care T.CC.28 Family History Dates with Disease Suffered, Age of Death, other genetic information T.CC.29 Social History Patient's beliefs, home life, social/risky habits, family life, work history T.CC.30 Encounters Current and historical encounters; dates T.CC.31 Medical Implanted and External Medical List of devices and where the Equipment Devices; Dates device is to be Medical Devices secured/embedded. (C/N) - includes Duration of medical devices. assistive History of devices (recalls, S/N, devices and is etc.). related to functional status T.CC.32 Preoperative Diagnosis (Date) assigned to Diagnosis patient previously to surgery T.CC.33 Postoperative Diagnosis (Date) assigned to Diagnosis patient after surgery T.CC.34 Surgery Particulars of Surgery Description (narrative) (images) T.CC.35 Surgical Clinically significant Operation Note observations found during Findings surgery T.CC.36 Complications Known risks or unidentified Section problems 8/1/2011 50 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Ref. 5 Section Content Additional Notes T.CC.37 Operative Note Date and Description of Surgical Procedure Performed Procedure Discharge Diet Part of Discharge Instructions Functional Part of Discharge Instructions Status Plan of Care Part of Discharge Instructions Table 16: Dataset for Discharge Summary Dataset for Clinical Summary: The User Stories Sub-Workgroup defined the following clinical summary content. Clinical Summary including Consultation Request Summary Clinical Summary always includes Core basic dataset: Demographic information, active medication list (with doses and sig), allergy list, problem list, reason for referral, etc. Clinical Summary contains variable dataset relevant to the context of the request: Examples: Cover note describing the clinical impetus for the referral For a cardiologist consultation request: cardiology relevant tests and results such as Cardiac Echo results, Holter Monitor results, etc.; cardiology-pertinent family history, social histories, procedures, PE findings, etc.. For a dermatologist consultation request: dermatology relevant tests and results such as skin biopsy path report, image of lesion, dermatology pertinent family history, social histories, procedures, PE findings, etc.. Specific example: o PCP has worked up a patient who has a working diagnosis of Thyroid Cancer and is referring the patient to an Endocrine Surgeon. o Summary includes standard basic dataset as above as well as PCP-selected referralspecific variable dataset. E.g.: Pertinent PE finding and history of present illness: 3 month history of a 2 cm R sided, hard thyroid nodule Pertinent results and diagnosis: FNA done 2/28/11 significant for medullary carcinoma, Calcitonin 2700, CEA 7, TSH, T3 Free T4 all normal Pertinent Additional Diagnoses Medical /Surgical Hx: significant only for 3 year history of mild obesity, current BMI 30 Pertinent Family History: significant for Thyroid cancer mother (unknown type). No family history of MEN Syndromes. No family history of radiation exposure. PCP referral request and determination of responsibility: Please evaluate for possible MEN II syndrome, surgery, post-operative care, and any special recommendations. I will assume full care status post the procedure. 8/1/2011 51 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Reference to shared information with Patient: I have reviewed all of the above information with the patient and his wife. Patient did/did not understand what was communicated Ref. 6 T.CC.1 Section Personal Information T.CC.2 Contact Information T.CC.3 Insurance Information T.CC.4 Healthcare Provider T.CC.5 Allergies/Other Adverse Reactions Content Name, DOB, Next of Kin, Address, Phone Number, Gender, Marital Status, Religion, Race, Ethnicity Contact Name, Contact Number Insurance Name, Phone #, Group #, Type, Member #, Subscriber Name, Financial responsibility Provider Name, Address, Phone Number, Type Allergy Type; and Date Substance intolerance Associated Adverse Events Additional Notes List of allergies which might include allergy to what (e.g., medication. food, environment). Yes/No/Unknown, and if Yes or Unknown how does it affect care. Other history that guide care T.CC.6 6 Problem List Active Problems (R/N)/Chief Complaint (overriding problem at the time of discharge) chronic illness and congenital problems Current Diseases & Conditions monitored for the patient and status Patient supplied information about reaction List of problems/complaints (what was diagnosis, complaint and/or descriptor of problem/complaints, symptoms). Is a list, of diagnosis, complaints some of these may have been resolved and some are active. How do these problems/complaints impact interventions, orders or instructions. Discharge instructions usually are for the encounter just ending. Patient's perception or description of problems/complaints is This identifier comes from the ONC SI-UC-Simplification spreadsheet (see References) 8/1/2011 52 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Ref. 6 Section Content Additional Notes usually in notes or history. Not part of a formal problem list. T.CC.7 History of Past Diseases & Conditions May be a list with dates onset and/or Illness/Resolved Patient has suffered in the resolution Problems past T.CC.8 Chief Complaint (see Description of Patient's If not listed, in the problem list change in T.CC.6 Complaint (narrative) Problem List) T.CC.9 Reason for Transfer Reason Patient is being May come from Utilization Review referred (UR) or Medicare rules, insurance or HMO rules or the patient may be well. T.CC.10 History of Present Sequence of events Illness proceeding patient's disease/condition T.CC.11 List of Surgeries List of types of surgeries and dates T.CC.12 Diagnosis List of Hospital Diagnosis Current encounter list only and dates T.CC.13 Medications List of Current Medication List of prescribed medications Names ; date, route, dose, or other medications. (Should frequency be the reconciled list (which should have been done on admission) If to be reconciled then list needs to be inclusive of selfadministered medications (herbals, over the counter) See notes on medication reconciliation regarding expectations such as discontinued medications from inpatient if not included in discharge summary NOTES: Instructions may be more detailed if sent to another provider T.CC.15 Advance Directives A summary of patient's expectations for care T.CC.16 8/1/2011 Pregnancy Yes/No, if Yes then date of Yes/No if POLST form returned Where is last known version/original is located Going forward how the "state" and how it affects care Pregnant, Yes/NO 53 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Ref. 6 Section Content Additional Notes T.CC.17 Immunizations Immunizations name, dose, Comprehensive list of immunizations route, date administered to (have - patient reported, got, the patient need):* list of immunizations necessary to get after discharge.* list of education or information about immunizations they received while hospitalization T.CC.18 Physical Examination Physical Findings of the Patient; VS, Biometrics, Review of Systems T.CC.19 Vital Signs Patient's Vital Signs ; Heart Instructions regarding the capture of Vital Signs (R/N) rate, Resp Rate, Pulse Ox, vital signs at points along the care including Pain Scale Temp, B/P, Pain plan and any special instructions Assessment, Smoking regarding how to capture Status T.CC.20 Review of Systems Functions of various body systems; Neuro, Derm, GI, GU, Cardiac, Pulmonary, MS, Repro, Nervous, Endocrine T.CC.21 Diagnostic Results Results and dates of Corresponding results to the Diagnostic Procedures scheduled procedures and interventions. T.CC.22 Plan of Care Proposed interventions and Goals. Plan of procedures for patient Results yet to be received and Treatment/Treatment procedures to be followed up Plan/Care Plan (R/N) on. Covers the Active interventions and considerations that orders (short term direct encompass a range of instructions - in the long run scopes and/or as validated by the patient timeframe (could be and those contributed by the a description of a patient/caregiver). single encounter or across multiple encounters Education Diet/Diet Restrictions Diet: (R/N) - All instructions that describe the ordered diet. Fluids Management (Conditional/No) 8/1/2011 Restrictions: - List of limitations being placed on the diet Fluids: - All instructions that describe the 54 Ref. 6 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Section Content Additional Notes expected fluids and method of administration. Restrictions: - List of limitations being placed on fluids Yes/No-has the plan been reviewed with the patient? Yes/No-has the plan been accepted by the patient, if no then how addressed T.CC.23 Family History T.CC.24 Social History T.CC.25 Encounters T.CC.26 Medical Equipmentincludes assistive devices and is related to functional status Preoperative Diagnosis T.CC.27 T.CC.28 T.CC.29 T.CC.30 T.CC.31 T.CC.32 T.CC.33 Diagnosis (date) assigned to patient previously to surgery Postoperative Diagnosis (date) assigned to Diagnosis patient after surgery Surgery Description Particulars of Surgery (narrative) (images) Surgical Operation Clinically significant Note Findings observations found during surgery Complications Section Known risks or unidentified problems Operative Note Date and description of Surgical Procedure Procedure Performed Electronic Links ADDED Functional Status (Optional/No) ADDED Relevant Diagnostic 8/1/2011 Dates with Disease Suffered, Age of Death, other generic information Patient’s beliefs, home life, social/risky habits, family life, work history Current and historical encounters; dates Implanted and External Devices; dates List of devices and where the device is to be secured/prescribed/embedded. Duration of medical devices. History of devices (recalls/S/N, etc.) How to get future results, summaries, etc Baseline, current and desired: Functional Status End state, Goal Expressed, Projected change in functional status (will relate to the goals identified) 55 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Ref. 6 Section Content Additional Notes Surgical Procedures/Clinical Reports and Relevant Diagnostic Test and Reports ADDED Patient Administrative Identifiers Table 17: Dataset for Clinical Summary Consultation Summary for specialist notes: Summary always includes Core dataset: Demographic information, specialist-reconciled active medication list (with doses and sig when known), allergy list, specialist-reconciled problem list, specialist recommendations, etc. Summary contains variable dataset relevant to the context of the referral: Pertinent findings, test or study results, procedures or operations and reports, indication of any specialty ongoing follow up responsibilities, what has been communicated to the patient, patient’s level of understanding of what was communicated, etc. Ref.7 Section Content T.CC.1 Personal Information Name, DOB, Next of Kin, Address, Phone Number, Gender, Marital Status, Religion, Race, Ethnicity T.CC.2 Contact Information Contact Name, Contact Number T.CC.3 Insurance Information Insurance Name, Phone #, Group #, Type, Member #, Subscriber Name, Financial responsibility T.CC.4 Healthcare Provider Provider Name, Address, Phone Number, Type T.CC.5 Allergies and Other Adverse Reactions Allergy Type; and Date Substance intolerance 7 Notes by Sub-Workgroup List of allergies which might include allergy to what (e.g., This identifier comes from the ONC SI-UC-Simplification spreadsheet (see References) 8/1/2011 56 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Ref.7 Section Content Notes by Sub-Workgroup Associated Adverse Events medication. food, environment) Yes/No/Unknown, and if Yes or Unknown how does it affect care. Other history that guide care. Patient supplied information about reaction T.CC.6 Problem List Current Diseases List of problems/complaints by patient to specialist and what was diagnosis, complaint and/or descriptor of problem/complaints, symptoms Active Problems (R/N)/Chief Complaint (overriding problem at the time of discharge) - chronic illness and congenital problems Conditions monitored for the patient and status How do these problems/complaints impact interventions, orders or instructions. Patient's perception or description of problems/complaints - was there discussion with patient? T.CC.7 History of Past Illness Diseases & Conditions Patient has suffered in the past Optional if relevant new discovery - resolved problems T.CC.8 Chief Complaint (see change in T.CC.6 Problem List) Description of Patient's Complaint (narrative) If patient tells specialist different complaint than was reported by PCP T.CC.9 8/1/2011 Reason Patient is being referred 57 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Ref.7 Section Content Notes by Sub-Workgroup T.CC.10 History of Present Illness Sequence of events proceeding patient's disease/condition If different or in addition to PCP history T.CC.11 List of Surgeries and Procedures List of types of surgeries and procedures with date If any performed by specialist T.CC.14 Medications List of Current List of prescribed medications Medication Names ; date, or medications administered route, dose, frequency by specialist If to be reconciled then list needs to be inclusive of selfadministered medications (herbals, over the counter) T.CC.17 Medications Administered Medications administered to patient during the course of an encounter; name, dose, route, frequency If relevant to referral T.CC.18 Advance Directives A summary of patient's expectations for care Yes/No (Optional in context of Consultation) T.CC.19 Pregnancy Pregnant, Yes/NO Only if relevant T.CC.20 Immunizations Immunizations name, dose, route, date administered to the patient Immunizations administered or recommended by specialist T.CC.21 Physical Examination Physical Findings of the Patient; VS, Biometrics, Review of Systems Pertinent positive or negative finding only T.CC.22 Vital Signs Patient's Vital Signs ; Heart rate, Resp Rate, Pulse Ox, Temp, B/P, Pain Pertinent positive or negative findings only Vital Signs (R/N) including Pain Scale Assessment, Smoking Status 8/1/2011 58 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Ref.7 Section Content Notes by Sub-Workgroup T.CC.23 Review of Systems Functions of various body systems; Neuro, Derm, GI, GU, Cardiac, Pulmonary, MS, Repro, Nervous, Endocrine Pertinent positive or negative findings only T.CC.25 Diagnostic Results Results and dates of Diagnostic Procedures Corresponding results to the scheduled procedures and interventions. T.CC.26 Assessment and Plan Assessment of patients conditions and expectations/goals of care See Plan of Care in regards discussions with patient T.CC.27 Recommended Plan of Care Proposed interventions and procedures Goals. Details for follow-up, expectations, as needed. Plan of Treatment/Treatment Plan/Care Plan (R/N) - Covers the considerations that encompass a range of scopes and/or timeframe (could be a description of a single encounter or across multiple encounters Active interventions and orders (short term direct instructions - in the long run as validated by the patient and those contributed by the patient/caregiver). Yes/No - has the specialist findings, recommendations and instruction been reviewed with the patient. Yes/No - Have these instruction been accepted by the patient, if no then how addressed Yes/No - Has patient been involved in formulation of plan of care 8/1/2011 59 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Ref.7 Section Content Notes by Sub-Workgroup Education Patient education provided or needed. To include classes, educational sessions, and printed materials. If relevant Fluids Management (Conditional/No) All instructions that describe the expected fluids and method of administration. If relevant T.CC.28 Family History Dates with Disease Optional if relevant Suffered, Age of Death, other genetic information T.CC.29 Social History Patient's beliefs, home life, social/risky habits, family life, work history Optional if relevant T.CC.31 Medical Equipment Implanted and External Medical Devices; Dates List of devices and where the device is to be secured/prescribed by specialist. Medical Devices (Conditional/No) - includes assistive devices and is related to functional status Optional if implanted or applied or with special instructions by specialist History of devices for this patient. Functional Status (Optional/No) -scales, scores 8/1/2011 SHOULD be present when any assessments of functional status are performed on the patient If relevant - Baseline, current and desired:* Functional status* End state/goal expressed/Projected change in functional status (will relate to the goals identified) 60 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Ref.7 Section Content Notes by Sub-Workgroup Electronic Links How to get to future results, summaries, etc. Table 18: Dataset for Clinical Summary for Specialist Notes APPENDICES Appendix A: Related Use Cases AHIC Consultations and Transfers of Care AHIC Consumer Empowerment; Consumer Access to Clinical Information AHIC Common Data Transport AHIC Clinical Notes Detail AHIC Personalized Healthcare NHIN Direct Primary care provider refers patient to specialist including summary care record NHIN Direct Primary care provider refers patient to hospital including summary care record NHIN Direct Specialist sends summary care information back to referring provider NHIN Direct Hospital sends discharge information to referring provider Appendix B: Previous Work Efforts Related to Clinical Information Exchange Health Information Technology Standards Panel Specification IS03: The Consumer Empowerment and Access to Clinical Information via Networks Interoperability Specification defines specific standards needed to assist patients in making decisions regarding care and healthy lifestyles (i.e., registration information, medication history, lab results, current and previous health conditions, allergies, summaries of healthcare encounters and diagnoses). This Interoperability Specification defines specific standards needed to enable the exchange of such data between patients and their caregivers via networks. Health Information Technology Standards Panel Specification IS09: The Consultations and Transfers of Care Interoperability Specification describe the information flows, issues and system capabilities that apply to a provider requesting and a patient receiving a consultations from another provider. HITSP Information Technology Standards Panel Specification C32: The Summary Documents Using HL7 Continuity of Care Document (CCD) Component describes the document content summarizing a consumer's medical status for the purpose of information exchange. The content may include administrative (e.g., registration, demographics, insurance, etc.) and clinical (problem list, medication list, allergies, test results, etc) information. This Component defines content in order to promote interoperability between participating systems such as Personal 8/1/2011 61 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Health Record Systems (PHRs), Electronic Health Record Systems (EHRs), Practice Management Applications and others. Health Information Technology Standards Panel Specification C83: The CDA Content Modules Component defines the content modules for document based HITSP constructs utilizing clinical information. These Content modules are based on IHE PCC Technical Framework Volume II, Release 4. That technical framework contains specifications for document sections that are consistent with all implementation guides for clinical documents currently selected for HITSP constructs. View the most current version as HTML Health Information Technology Standards Panel Specification IS107: This Interoperability Specification consolidates all information exchanges and standards that involve an EHR System amongst the thirteen HITSP Interoperability Specifications in place as of the February 13, 2009 enactment of the American Recovery and Reinvestment Act (ARRA). This Interoperability Specification is organized as a set of HITSP Capabilities, with each Capability specifying a business service that an EHR system might address in one or more of the existing HITSP Interoperability Specifications (e.g., the Communicate Hospital Prescriptions Capability supports electronic prescribing for inpatient prescription orders) Health Level 7: The CDA Release 2.0 provides an exchange model for clinical documents (such as discharge summaries and progress notes) - and brings the healthcare industry closer to the realization of an electronic medical record. By leveraging the use of XML, the HL7 Reference Information Model (RIM) and coded vocabularies, the CDA makes documents both machinereadable - so they are easily parsed and processed electronically - and human-readable - so they can be easily retrieved and used by the people who need them. CDA documents can be displayed using XML-aware Web browsers or wireless applications such as cell phones. While Release 2.0 retains the simplicity of rendering and clear definition of clinical documents formulated in Release 1.0 (2000), it provides state-of-the-art interoperability for machinereadable coded semantics. The product of 5 years of improvements, CDA R2 body is based on the HL7 Clinical Statement model, is fully RIM-compliant and capable of driving decision support and other sophisticated applications, while retaining the simple rendering of legallyauthenticated narrative. Appendix C: Privacy and Security Assumptions Security attributes includes capabilities needed to establish trust between systems, provide confidentiality while in-transit, ensure authenticity of the data, and ensure that only authorized individuals have access to the data. Feature Audit Logging Authentication (Person) Authentication (System) Data Integrity Checking Error Handling HIPAA De-Identification 8/1/2011 Feature Applicability X X X X X X 62 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Feature Feature Applicability Holding Messages Non-repudiation Pseudonymize and Re-Identify Secure Transport Transmit Disambiguated Identities User Login X X X X Table 19: Common Transactions (not displayed as part of the sequence diagram) Appendix D: Glossary These items are included to clarify the intent of this use case. They should not be interpreted as approved terms or definitions but considered as contextual descriptions. There are parallel activities underway to develop specific terminology based on consensus throughout the industry. Access Logs: An integrated view of who has accessed the consumer/patient’s health information for the purposes of direct or indirect patient care. Acute Care: Treatment for a short period of time in which the patient is treated for a brief episode of illness. Acute Care is generally associated with care in a short term facility which is usually a nonemergency department setting. AHIC: American Health Information Community; a federal advisory body chartered in 2005, serving to make recommendations to the Secretary of the U.S. Department of Health and Human Services in regards to the development and adoption of health information technology. Ancillary Entities: Organizations that perform auxiliary roles in delivering healthcare services. They may include diagnostic and support services such as laboratories, imaging and radiology services, and pharmacies that support the delivery of healthcare services. These services may be delivered through hospitals or through free-standing entities. Care Coordination: Functions that help ensure that the patient’s needs and preferences for health services and information sharing across people, functions, and sites are met over time. Care Coordinators: Individuals who support clinicians in the management of health and disease conditions. These can include case managers and others. Clinical Support Staff: Individuals who support the workflow of clinicians. Clinicians: Healthcare providers with patient care responsibilities, including physicians, advanced practice nurses, physician assistants, nurses, psychologists, pharmacists, and other licensed and credentialed personnel involved in treating patients. Consultation: Meeting of two or more clinicians to evaluate the nature and progress of disease in a particular patient and to establish diagnosis, prognosis, and therapy. Consumers: Members of the public that include patients as well as caregivers, patient advocates, surrogates, family members, and other parties who may be acting for, or in support of, a patient receiving or potentially receiving healthcare services. 8/1/2011 63 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Electronic Health Record (EHR): An electronic, cumulative record of information on an individual across more than one healthcare setting that is collected, managed, and consulted by professionals involved in the individual's health and care. This EHR description encompasses similar information maintained on patients within a single care setting (a.k.a., Electronic Medical Record (EMR)). Electronic Health Record (EHR) System Suppliers: Organizations which provide specific EHR solutions to clinicians and patients such as software applications and software services. These suppliers may include developers, providers, resellers, operators, and others who may provide these or similar capabilities. Geographic Health Information Exchange/Regional Health Information Organizations: A multistakeholder entity, which may be a free-standing organization (e.g., hospital, healthcare system, partnership organization) that supports health information exchange and enables the movement of health-related data within state, local, territorial, tribal, or jurisdictional participant groups. Activities supporting health information exchanges may also be provided by entities that are separate from geographic health information exchanges/Regional Health Information Organizations including integrated delivery networks, health record banks, and others. Health Information Exchange (HIE): An electronic network for exchanging health and patient information among healthcare delivery organizations, according to specific standards, protocols, and other agreed criteria. These functional capabilities may be provided fully or partially by a variety of organizations including free-standing or geographic health information exchanges (e.g., Regional Health Information Organizations (RHIOs)), integrated care delivery networks, provider organizations, health record banks, public health networks, specialty networks, and others supporting these capabilities. This term may also be used to describe the specific organizations that provide these capabilities such as RHIOs and Health Information Exchange Organizations. Healthcare Payers: Insurers, including health plans, self-insured employer plans, and third party administrators, providing healthcare benefits to enrolled members and reimbursing provider organizations. HITSP: The American National Standards Institute (ANSI) Healthcare Information Technology Standards Panel; a body created in 2005 in an effort to promote interoperability and harmonization of healthcare information technology through standards that would serve as a cooperative partnership between the public and private sectors. Laboratories: A laboratory (often abbreviated lab) is a setting where specimens are sent for testing and analysis are resulted, and then results are communicated back to the requestor. The types of laboratories may include clinical/medical, environmental, and veterinarian, and may be both private and/or public. ONC: Office of the National Coordinator for Health Information Technology; serves as the Secretary’s principal advisor on the development, application, and use of health information technology in an effort to improve the quality, safety, and efficiency of the nation's health through the development of an interoperable harmonized health information infrastructure. Patients: Members of the public who receive healthcare services. For hospice providers, the patient and family are considered a single unit of care. Synonyms used by various healthcare fields include client, resident, customer, patient and family unit, consumer, and healthcare consumer. 8/1/2011 64 Department of Health and Human Services (HHS) Office of the National Coordinator (ONC) Use Case Development and Functional Requirements for Interoperability Transition of Care Use Case Personal Health Record: A health record that is initiated and maintained by an individual. An ideal PHR would provide a complete and accurate summary of the health and medical history of an individual by gathering data from many sources and making this information accessible online to anyone who has the necessary electronic credentials to view the information. Pharmacies: Entities that exist that are experts on drug therapy and are the primary health professionals who optimize medication use to provide patients with positive health outcomes Provider: An individual clinician in a care delivery setting who requests or accepts the transfer of the clinical summary for the purposes of delivering care. Provider Organizations: Organizations that are engaged in or support the delivery of healthcare. These organizations could include hospitals, ambulatory clinics, long-term care facilities, community-based healthcare organizations, employers/occupational health programs, school health programs, dental clinics, psychology clinics, care delivery organizations, pharmacies, home health agencies, hospice care providers, and other healthcare facilities. Registries: Organized systems for the collection, storage, retrieval, analysis, and dissemination of information to support health needs. This also includes government agencies and professional associations which define, develop, and support registries. These may include emergency contact information/next of kin registries, patient registries, disease registries, etc. Appendix E. References American Health Information Community; AHIC; www.hhs.gov/healthit/healthnetwork/background The American National Standards Institute (ANSI) Healthcare Information Technology Standards Panel; HITSP; www.HITSP.org Health Level Seven; HL7; www.HL7.org Meaningful Use Final Rule; Dept of Health and Human Services; www.edocket.access.gpo.gov/2010/pdf/2010-17207.pdf Nationwide Health Information Network; NHIN; www.hhs.gov/healthit/healthnetwork/background The ONC-SI-UC-Simplification Spreadsheet (Current Version) http://wiki.siframework.org/Cross+Initiative+-+Use+Case+Simplification+SWG 8/1/2011 65