Use Case and Functional Requirements Development for Interoperability Public Health Reporting Initiative Public Health Reporting Initiative Use Case: Provider-Initiated Report from EHR System to Public Health Agency System 4/30/2012 This document reflects the Public Health Reporting Initiative Use Case as of April, 2012. This document may be revised going forward based on Meaningful Use Stage 2 requirements and the ongoing and future work of the initiative including functional requirements development, data modeling, and implementation specification development. This document has been updated based on comments received during both the internal and public comment review periods. <<Date>> 1 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative Table of Contents 1.0 Preface and Introduction .................................................................................................................. 4 2.0 Initiative Overview ............................................................................................................................ 4 2.1 3.0 Initiative Challenge Statement...................................................................................................... 5 Use Case Scope ................................................................................................................................. 6 3.1 Background ................................................................................................................................... 6 3.2 In Scope ......................................................................................................................................... 7 3.3 Out of Scope.................................................................................................................................. 8 3.4 Stakeholders ................................................................................................................................. 9 4.0 Value Statement ............................................................................................................................. 10 5.0 Use Case Assumptions .................................................................................................................... 11 6.0 Pre-Conditions ................................................................................................................................ 12 7.0 Post Conditions ............................................................................................................................... 12 8.0 Actors and Roles ............................................................................................................................. 12 9.0 Triggers............................................................................................................................................ 13 10.0 Use Case Diagram ........................................................................................................................... 13 11.0 Scenario: EHR System Sends Report to Public Health Agency System ........................................... 14 11.1 User Story.................................................................................................................................... 14 11.1.1 Communicable Disease ....................................................................................................... 15 11.1.2 Chronic Disease ................................................................................................................... 15 11.1.3 Newborn / Child Health ...................................................................................................... 16 11.1.4 Adverse Events .................................................................................................................... 17 11.1.5 Infrastructure/Quality/Research......................................................................................... 18 11.2 Activity Diagram .......................................................................................................................... 18 11.2.1 Base Flow ............................................................................................................................ 19 11.2.2 Alternate Flow..................................................................................................................... 20 11.3 Functional Requirements ............................................................................................................ 22 11.3.1 12.0 Sequence Diagram .............................................................................................................. 22 Policy and Regulatory Issues ........................................................................................................... 22 Appendices.................................................................................................................................................. 24 Appendix A: User Stories........................................................................................................................ 24 <<Date>> 2 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative Communicable Disease Consolidated User Story (Reporting from EHR system) ............................... 24 Chronic Disease Consolidated User Story #1 ...................................................................................... 25 Chronic Disease Consolidated User Story #2 ...................................................................................... 27 Child Health Consolidated User Story – Birthing Facility .................................................................... 28 Child Health Consolidated User Story – Outpatient Setting ............................................................... 29 Adverse Events Consolidated User Story ............................................................................................ 30 Appendix B: Acronyms ........................................................................................................................... 31 Appendix C: Glossary of Terms .............................................................................................................. 31 List of Figures: Figure 1: Use Case Diagram ....................................................................................................................... 13 Figure 2: Activity Diagram .......................................................................................................................... 19 Figure 3: Sequence Diagram ...................................................................................................................... 22 List of Tables: Table 1: Key Stakeholders ........................................................................................................................... 10 Table 2: Actors and Roles ............................................................................................................................ 12 Table 3: Base Flow ...................................................................................................................................... 20 Table 4: Alternate Flow ............................................................................................................................... 21 <<Date>> 3 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative 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 healthcare 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, payers, 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 and their specifications 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 Initiative Overview The Public Health Reporting Initiative (PHRI) is a community-led S&I Framework initiative focused on harmonizing information exchange standards and creating implementation specifications for public health1 reporting from healthcare providers to public health agencies. Our goal is to create a harmonized specification that can be used to help reduce costs and reporting burden of healthcare providers to public health agencies. The new specification can be used to promote health information technology (HIT) adoption and facilitate electronic public health reporting from EHR systems. The PHRI consolidated use case was derived using a representative sample of existing public health reporting scenarios. These scenarios are grouped into reporting domains for Chronic Disease, Communicable Disease, Child Health, and Adverse Events. This grouping approach will be used to identify common data elements and reporting functional requirements to create an extensible EHR reporting specification that could be more broadly applied to other public health reporting scenarios over time. For this use case, “public health reporting” refers to information exchange between healthcare providers such as private physician practices and hospitals to a public health agency. In particular, this use case will address electronic transmission of EHR-generated or assisted healthcare provider reports, and receipt or retrieval by the public health agency. Report content for this use case is based upon patient-level EHR data that is extracted and/or reused to create compliant reports that meet reporting criteria of the representative public health report types (domains) supported in the use case. 1 The term “public health,” as used in this document, refers to public health and patient safety programs. <<Date>> 4 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative The Initiative recognizes the challenges of defining a single use case and harmonizing reporting specifications for multiple public health reporting agencies and report types. To help address this challenge, the Initiative solicited and examined many different user stories from stakeholder participants, which represent requirements across several reporting programs. As previously described, the resulting public health reporting domains for Child Health, Communicable Disease, Chronic Disease and Adverse Events will be further refined to create a functional requirements specification for an overall public health reporting scenario for sending an electronic report from a healthcare provider’s EHR system to a public health agency. In the short-term, the Initiative seeks to define criteria and requirements for improved data exchange standards, specifications and validation rules for sending EHR-generated or assisted reports from a healthcare provider to a public health agency. The long-term goals of the initiative include: Reduce variability in data exchange standards supported by different public health agency systems covering the same or different jurisdictions Increase interoperability and data exchange from healthcare providers to public health agencies Reduce the burden on senders to create and manage different data exchanges based upon the use of the same or similar source clinical or administrative data Reduce the burden on public health agencies to receive, extract, translate, load, and analyze information contained in healthcare provider reports. Future Use Cases that could be developed include exchanges between Health Information Exchanges (HIEs) and public health laboratories, exchanges between state, local or federal public health agencies, and exchanges for events of public health interest involving non-human subjects. 2.1 Initiative Challenge Statement Much public health reporting currently relies on paper forms that are mailed, emailed or faxed; thus necessitating manual data entry and coding by the public health agency prior to initiating analysis or follow-up. There is relatively little, but increasing nationwide standardization of public health electronic information exchange. Even when reporting is performed electronically, there are multiple regulatory or statutory requirements and implementation specifications that cover different reporting activities. Varied reporting requirements and methods impose burdens on both healthcare providers and public health agencies to support multiple formats and manage competing requirements defined by mandated or voluntary reporting programs. Additionally, multiple data exchange standards used for public health reporting (e.g., HL7 Versions 2.x and 3 messages and HL7 Clinical Document Architecture (CDA)) introduce additional variability across reporting programs because of differences in data standards adoption and implementation timelines, data elements, terminology and metadata. The need to accommodate and manage these variations and extensibility of existing data exchanges increases the costs and barriers for reporting, data sharing and data reuse for both the senders and receivers of public health reports. The PHRI aims to address some of these issues by identifying common reporting requirements, e.g., data elements, terminology, report generation workflow and infrastructure that can be used to help refine <<Date>> 5 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative and recommend standards and implementation specifications. These specifications can be used to help streamline electronic reporting from EHRs to public health, and also help identify needed changes to regulatory and statutory policies that further complicate or hinder broader EHR adoption and reuse of EHR data for downstream uses such as public health reporting. Successful completion of this initiative will help reduce or eliminate redundant reporting standards, specifications and create a framework for leveraging solutions that can accommodate a broader range of reporting scenarios. Additionally, the initiative hopes to highlight gaps and issues that can be used as a future catalyst for addressing various discrepancies or overlaps in federal, state and local regulations that confuse reporters or inadvertently create standards adoption burdens on healthcare providers. The anticipated public health benefit of a successful initiative is a more timely, reliable, secure, standardized and efficient public health reporting infrastructure (standards, terminology, specifications and tools) for healthcare providers. Public health agencies may be able to improve their public health surveillance and risk/harm mitigation activities, which should result in reductions in preventable disease, disability and death. 3.0 Use Case Scope The scope of this Use Case is limited to the use of a healthcare provider’s EHR system for reporting patient-level events of public health interest to a public health agency. This Use Case focuses on a provider-initiated report – a report sent from a provider (using an EHR system) to a public health agency system with information about a particular public health event. The report (at a minimum) will contain specific information about what occurred and the relevant patient-level information. For example, a report about a patient’s health condition or disease (suspected or confirmed) by a healthcare provider to authorized local, state, or federal public health agencies. The common dataset for this use case is derived from the core data elements described across all reporting domains (e.g., communicable disease, chronic disease, child health, adverse events) that are needed to meet the reporting criteria for the public health agency programs represented in this phase of work. In the context of this initiative’s use case, the reporting process is facilitated by the healthcare provider’s EHR and assumes that the EHR system contains or is used to create all relevant information (e.g., demographic, clinical, laboratory, pharmacy, etc.) to create and send a report to a public health agency. The reporting scenario for this use case describes two potential information flows from the EHR system to the public health agency. The primary report flow involves the transmission of a report directly from the provider’s EHR system to the public health agency system. The alternate report flow involves the transmission of the report from the EHR system to an intermediary system such as a Health Information Exchange or similar intermediary (e.g., Incident Reporting System) to a public health agency. The functional requirements supported by this use case support the active reporting process initiated by the healthcare provider, and are consistent with established state, local or federal mandates. 3.1 Background On February 17, 2009, the President signed the American Recovery and Reinvestment Act of 2009 (ARRA). This statute includes the Health Information Technology for Economic and Clinical Health Act of <<Date>> 6 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative 2009 (the HITECH Act) that set forth a plan for advancing the Meaningful Use (MU) of health information technology (HIT) to improve quality of care and establish a foundation for healthcare reform. Two Federal Advisory Committees, Health IT Policy and Health IT Standards have been established under this legislation. In 2010 these Committees identified three types of public health reporting that were adopted for MU Stage 1 of the HITECH-funded Centers for Medicare and Medicaid Services (CMS) Incentive Program: Capability to submit electronic syndromic surveillance data to public health agencies and actual transmission according to applicable law and practice. Capability to submit electronic data to immunization registries of Immunization Information Systems and actual submission in accordance with applicable law and practice. Capability to submit electronic data on reportable (as required by state or local law) lab results to public health agencies and actual submission in accordance with applicable law and practice. Both Committees recognize that these three types of public health reporting represent just a few of the many types of ongoing information exchange between healthcare providers and public health agencies, and that creating a unique implementation specification for each would impose long-term burdens on healthcare providers and agencies alike. Both have suggested that simpler approaches to managing public health reporting be considered for future stages of Meaningful Use2. ONC manages the S&I Framework to leverage existing and new HIT standards and tools, and to harmonize and implement standards specifications (implementation specifications) in order to promote electronic health information exchange interoperability nationwide. In 2011, several S&I Framework Initiatives were established to provide clarification in HIT standards selected for MU and guide standards-based products and certification including the Laboratory Results Interface (LRI) Workgroup and its Public Health Laboratory Reporting Workgroup. The Public Health Laboratory Reporting Workgroup recognized that additional information is needed for prompt assessment and response to reportable diseases beyond that contained in the MU Stage 1 implementation specification for laboratory result reporting. Similar types of information are needed for other kinds of public health reports. During the ONC S&I Framework face-to-face meeting in Washington DC, June 14-15, 2011 the LRI Public Health Workgroup proposed establishing the Public Health Reporting Initiative within the ONC S&I Framework to better understand public health reporting needs and define standards-based interoperability specifications. 3.2 In Scope The following activities are in scope for the PHRI Use Case. 2 Describing the stakeholders and actors for each public health reporting User Story Identifying and harmonizing the core reporting data elements required by public health agencies for reportable events Letter of June 16, 2011 from HITPC chairs to the National Coordinator for HIT. <<Date>> 7 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative 3.3 Defining a standard exchange format including structure and content (i.e., vocabulary) Defining the requirements for limited bi-directional3 exchange – sending the report, receiving the report, and acknowledging receipt Identifying the requirements to send reports from certified EHR systems (in all clinical settings where EHR data is used for reporting purposes – inpatient, outpatient, emergency room, urgent care, etc.) to public health agencies (Note: reports may include administrative, laboratory, pharmacy and/or other information imported from separate systems into the EHR) Supporting all relevant federal, state, and local regulations to the best extent possible when creating the harmonized standards and specifications Out of Scope The following activities are out of scope for the PHRI Use Case. Defining specifications and guidelines on reportable event criteria (e.g., defining reportable conditions) – this Initiative will enable healthcare providers to submit a report based on jurisdictionally defined laws and regulation, but will not be responsible for defining the reporting criteria. Describing the process for healthcare providers to add information into an EHR or auxiliary system Describing the process for public health agencies to perform follow-up activities, including case monitoring Defining specifications and guidelines for reporting by means other than the transmission of an electronic message or document (e.g., telephone voice, manual web-entry and mailed or faxed information) Describing any additional or extensive bi-directional communication between a public health agency and a healthcare provider beyond the sending of a public health report and the acknowledgement of receipt of that report Identifying transport protocols Identifying security requirements, methodologies, procedures, and/or protocols Identifying information and data stewardship practices and policies The Initiative acknowledges that there are several exchanges described in various user stories that are not explicitly harmonized for phase of work. The following exchanges will be considered for future harmonization with this use case: Queries to electronic health records for surveillance or research purposes; Transactions between EHRs and other ancillary systems such as Laboratory Information Systems or Incident Reporting Systems 3 Note that further bi-directional communication (e.g., a follow-up for additional information by the public health agency system) is out of scope for this use case, but may be considered by future phases of the Public Health Reporting Initiative. <<Date>> 8 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative 3.4 Stakeholders The key stakeholder groups interested in this Use Case and the associated standards and implementation specifications are included in the table below. Stakeholders Healthcare Provider Public Health Agency Electronic Health Record (EHR) / Electronic Medical Record (EMR) / Personal Health Record (PHR) Vendors and Suppliers Public Health Information System Vendors/Suppliers Standards Development Organizations Health Information Exchange Organizations Patient Safety Organization Quality improvement/measurement organizations Laboratory <<Date>> Description Any supplier of a healthcare service; person or organization that furnishes, bills, or is paid for healthcare in the normal course of business. Includes physicians and healthcare provider staff, as well as ancillary healthcare personnel (e.g., lab personnel) An entity under the jurisdiction of the U.S. Department of Health and Human Services, tribal organization, State level and/or city/county level administration that serves a public health function. An EHR is an electronic record of health-related information on an individual that conforms to nationally recognized interoperability standards and that can be created, managed, and consulted by authorized providers and staff across more than one health care organization. An EMR is an electronic record of health-related information on an individual that can be created, gathered, managed, and consulted by authorized providers and staff within one health care organization. A PHR is an electronic record of health-related information on an individual that conforms to nationally recognized interoperability standards and that can be drawn from multiple sources while being managed, shared, and controlled by the individual. A vendor or supplier is a company/consortium that provides products and/or services. Public health Information Systems: applications which may, among other things, receive Public health Reports Organizations key to identifying, balloting, approving, and maintaining health information exchange standards, including exchange, terminology, security, and transport protocols. Organizations (including state Designated Entities for Health Information Exchange, as well as other organizations managing information exchange among different corporate entities). Includes Regional Health Information Organizations (RHIOs). A group, institution or association that improves medical care by reducing medical errors A group of doctors and healthcare experts to check on and improve the care given to people. For example, QIO’s are key stakeholders in Hospital Acquired Infection reporting and in a range of care and transitions of care issues including the reporting and control of healthcare associated infections. The laboratory is a producer of lab test results (filler of a lab order). 9 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative Stakeholders Laboratory Information System (LIS), Vendors/Suppliers Description An application to streamline the management of laboratory processes including data collection, workflow management, and report generation. May provide an automatic interface to laboratory analytical instruments to transfer verified results to nurse stations, chart carts, and remote physician offices. Table 1: Key Stakeholders 4.0 Value Statement Public health agencies rely on health information captured and/or generated during healthcare processes and interactions with individual patients to save lives and reduce disability and illness by identifying threats (such as outbreaks, epidemics and adverse trends like obesity); by assuring interventions (like infection control, prophylactic or therapeutic treatment, environmental intervention, and public risk communication); and monitoring outcomes to evaluate the effectiveness of both public health and medical prevention efforts. Collectively these information-dependent functions are referred to as public health surveillance. Historically, public health reports are submitted manually by phone, mail, fax and more recently, typing into internet forms. Because clinical information is increasingly stored and managed in Electronic Health Records, public health agencies have an opportunity and obligation to adapt their reporting methods and infrastructure to leverage EHR data for public health use. Electronic reporting of structured EHR data can help reduce or eliminate some of the manual processes involved in creating, sending, receiving, and analyzing public health reports. By leveraging emerging EHR technology, healthcare providers improve the speed, accuracy and completeness of reporting, and help enable improvements in public health agency response and mitigation of important public health events. The value of the Public Health Reporting Initiative will be to help facilitate HIT adoption and lower barriers of manual reporting methods by creating and promoting the use of a consensus-based standard and specification to support automated reporting of public health events from certified EHR systems. The initiative will leverage standardized health information models to support implementable, highvalue user stories, based on available, shareable and standardized information from EHRs. The Initiative’s artifacts may be leveraged to facilitate further extension of interoperable data exchanges to support other public health-related activities. To the extent that the Initiative can develop and successfully demonstrate the use of a practical specification in time for consideration for Stage 3 of Meaningful Use, it is anticipated that certified EHR systems will support and be capable of limited, bidirectional public health reporting using a harmonized implementation specification to support a variety of public health reporting scenarios and programs. While outside the scope of this Initiative and Use Case document, it is important to note the need for effective integration of public health reporting into the evolving HIT landscape, and this will require that public, private and academic organizations work together to understand and improve the overall <<Date>> 10 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative workflows and responses associated with multi-dimensional public health information exchange, including public health reporting. It is anticipated that as the Public Health Reporting Initiative evolves over time, there will be critical multi-stakeholder and multi-disciplinary assessments of the baseline standards, specifications and processes to help establish a longer term roadmap for addressing broader policy, workflow and IT burdens that affect overall improvements in public health programmatic outcomes. 5.0 Use Case Assumptions Patient-level clinical information is entered, imported, or accessed by a healthcare provider using an EHR System interface. Broadly-acceptable security and transport protocols, patient identification methodology, privacy and security procedures, coding, vocabulary, and normalization standards exist and are in use by the EHR system and Public Health Agency system. The healthcare provider (EHR) system contains all relevant information (e.g., demographic, clinical, laboratory, pharmacy, etc.). The EHR has or has to enable access to all needed data (electronic population of information is preferred, but information may be manually entered for legal purposes) to generate a complete and accurate public health report in accordance with the appropriate public health reporting domain requirements described in the new PHRI specification. Appropriate data and information stewardship practices are adopted by exchange partners. Established network and policy infrastructure will exist to enable consistent, appropriate, and accurate information exchange across healthcare provider systems, data repositories and locator services. Electronic Health Record Systems may be a single stand-alone system or based upon a component-based architecture where the EHR interfaces with other systems that are used to help populate or transmit the report to public health. The public health agency system is in place and capable of receiving the report in a standardized structured format. Public health agency information systems receive the public health report. These information systems may be a single stand-alone system or composed of a componentbased architecture that is used to receive and process the report for review and/or analysis. There are variations in requirements for reporting across local, state, tribal, and territorial boundaries, as well as voluntary versus mandatory requirements. The healthcare provider will locate or select the appropriate reporting criteria and has made provisions to electronically program or integrate the criteria into the EHR reporting process The reporting system is capable of sending the report to a public health agency in a standardized structured format. The HIE, if used, is responsible to pass the acknowledgement from the Public Health Agency system to the EHR system; the HIE may send separate acknowledgements, but these are not considered the authoritative acknowledgement. <<Date>> 11 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative 6.0 Pre-Conditions At least one of the following has occurred: The criteria for public health reporting have been met, including collecting all data and meeting all reportable event criteria and triggers The EHR system populates/generates a report using the all appropriate information (e.g., data elements and terminology) for the report type The report is verified or certified based upon the appropriate healthcare provider process and is released for transmission to the public health agency 7.0 Post Conditions The public health agency information system has received the report and sent acknowledgement of receipt to the EHR system The sending healthcare provider EHR system has received acknowledgement of receipt of the report A record of a report sent from the EHR to the public health agency is stored in a log 8.0 Actors and Roles Actor EHR System (healthcare provider system) Public Health Agency System Intermediary Systems, including Incident Reporting Systems, Health Information Exchange Systems, Health Information Networks, etc. that are used as intermediaries to communicate between EHR systems and Public Health Agency systems Role Collect, receive, and/or store patient-level data Supports additional data entry (e.g. populate data on an electronic form) Generate public health report and make it available for validation Send report to public health agency either directly or through an intermediary Receive acknowledgement either directly or through an intermediary Receive report from EHR system or intermediary Generate acknowledgement from public health agency Send acknowledgement to EHR system either directly or through an intermediary If applicable: Receive report from EHR system and send to public health agency system Receive acknowledgement from public health agency system and send acknowledgement to EHR system Table 2: Actors and Roles <<Date>> 12 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative 9.0 Triggers For the purpose of this document, the term, “trigger” is meant to convey the specified reporting criteria that is used to determine if a public health report should be sent to a public health agency, as jurisdictionally defined. The criteria can be based upon several factors that include but are not limited to: Reporting criteria as specified by jurisdictional (e.g., federal, state, local or territorial) legislation, statute or regulation. Surveillance criteria as specified by an organization (e.g., public health agency, healthcare provider, quality improvement organization, registry, etc.) Patient observations or other healthcare-related assessments made by healthcare providers or other staff EHR reporting triggers, including validation/certification processes will be further specified and documented in the Use Case Functional Requirements Document. 10.0 Use Case Diagram Figure 1: Use Case Diagram <<Date>> 13 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative 11.0 Scenario: EHR System Sends Report to Public Health Agency System In this scenario, an Electronic Health Record System sends a report to a public health agency information system based on a set of reporting criteria that are used to identify a public health event. This report may be sent directly by the EHR system or through an HIE or similar intermediary sending system. The high level EHR reporting process flow begins with the identification of an event of a possible reportable public health event. When the event meets the pre-specified reporting criteria, the EHR system renders or generates an electronic public health report. When the report has been verified, the EHR system sends the report to the public health agency system and updates a log to reflect the submission. The public health agency system receives the electronic report and sends an acknowledgement of receipt to the sending EHR system. The EHR system receives the acknowledgement. More specifically, the EHR reporting process includes the following high-level steps: The Public Health Agency determines the appropriate reporting criteria for a public health event. The healthcare provider or provider EHR determines how the criteria will be implemented with the EHR system infrastructure. As applicable, the reporting criteria are integrated into the provider’s patient care process or programmed into the EHR system. Once the EHR reporting criteria have been met, the EHR system prepares the public health report and allows for healthcare provider completion, verification, and certification (where necessary) Once the report is verified and/or certified for submission (where necessary), the EHR system generates the electronic public health report The EHR system sends the public health report to the public health agency system (or, if applicable, the intermediary system) and updates the log to reflect transmission The public health agency system receives the electronic report (either directly from the EHR system or from the intermediary system) The public health agency sends an acknowledgement of receipt to the sending EHR system, either directly or through the intermediary system The EHR system receives the acknowledgement The User Stories that follow have been consolidated and generalized from over 30 individual user story submissions. The User Stories below describe this scenario for selected public health domains – communicable disease, chronic disease, child health, and adverse events. 11.1 User Story The User Stories below are meant to be representative across the selected domains. These User Stories have been generalized from submissions received from stakeholder members of the Public Health Reporting Initiative. It is important to note that these consolidated user stories and supporting information in Appendix A provide a high-level description of public health reporting processes for the specific domains. There are <<Date>> 14 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative public health reporting user stories that present more complexities in specific reporting requirements. These types of requirements may be captured in the analysis of functional requirements, data elements and value sets for specific reporting implementations and/or examined during later stages of this initiative. 11.1.1 Communicable Disease A patient is admitted to a hospital / medical facility or comes to a healthcare provider’s office. The healthcare provider performs a clinical examination and evaluates the medical history of the patient. At this point, the healthcare provider may: Send a report to public health if the healthcare provider assessment indicates that the patient presents with clinically significant findings or otherwise meets the criteria for a legally mandated reportable condition (e.g., meets the criteria for legally mandated reportable condition and does not require laboratory confirmation to report) Order a diagnostic test, if the healthcare provider cannot rule out a reportable condition and the patient’s clinical presentation does not met reporting criteria without diagnostic testing. Upon receipt of test results, the healthcare provider re-examines diagnostic criteria and, if reporting criteria are met, sends a report to the public health agency including diagnostic test results. The public health agency information system receives the report and sends electronic acknowledgement of receipt to the EHR system. It is important to note that this consolidated user story and supporting Appendix A provide a high-level description of public health communicable disease reporting processes. There are public health reporting user stories (e.g. Healthcare Associated Infection reporting) that present more complexities in specific reporting requirements, including the reporting of numerator and denominators for the specific conditions. These types of requirements may be captured in the analysis of functional requirements for specific reporting implementations. 11.1.2 Chronic Disease A patient comes to a healthcare provider with symptoms of a disease or for a checkup. The healthcare provider completes a clinical examination and assesses medical history. The healthcare provider reports to a public health agency, depending on the reporting criteria. The healthcare provider orders laboratory (clinical or pathology) and/or any diagnostic tests. Diagnostic tests are performed and/or laboratory performs ordered tests on received specimens. The laboratory sends the results to the healthcare provider. The healthcare provider re-examines clinical findings and/or diagnostic/lab results and diagnoses a reportable condition. The EHR system sends the report to a public health agency information system, depending on the reporting criteria. The healthcare provider treats the patient, including a counseling session, if applicable. (Note: patient discharge data and/or hospital billing data are combined into the EHR, if applicable.) The EHR system sends the report to a public health agency information system, depending on the reporting criteria. The public health agency information system receives the report and sends electronic acknowledgement of receipt to the EHR system. <<Date>> 15 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative 11.1.3 Newborn / Child Health Newborn / Child Health reporting can be described through two user stories – each uses different data elements and has different public health reporting criteria. It is important to note that these consolidated user stories and supporting Appendix A provide high-level descriptions of public health newborn and child health reporting processes. There are public health reporting user stories that present more complexities in specific reporting requirements. These types of requirements may be captured in the analysis of functional requirements, data elements and value sets for specific reporting implementations. Newborn A child is delivered. The Newborn’s Electronic Health Record is established in the Birthing Facility EHR. The establishment of the Newborn record in the EHR serves as a trigger event for well child care to automate notifications with standing orders to conduct required newborn assessments and procedures within 24-48 hours of birth (prior to discharge) such as hearing screening, metabolic testing, initial birth defect assessment, Hepatitis B vaccination and other procedures. Consent for procedure and Consent for information exchange is obtained from the caregiver. The required newborn assessment/test is conducted; and the Hepatitis B vaccine is administered by the birthing facility staff. Information about assessment/ test/vaccination is entered into the EHR. The birthing facility EHR pre-populates the Facility Worksheet with the information needed by the vital statistics jurisdiction for the birth certificate or report of fetal death. According to jurisdiction-specific laws, Public Health Reports on hearing screening test results, initial birth defect assessment, and Hepatitis B vaccination are generated in Birthing Facility EHR. The provider collects additional information needed for these reports and enters that information in the Reports. The provider reviews, electronically signs and submits the Reports via health information exchange (HIE) or directly to the Public Health Authority according to jurisdiction-specific laws. The Public Health Authority information systems (early hearing detection and intervention information system, birth defect registry, immunization registry) receive the Report and sends electronic acknowledgement of receipt to the EHR system via HIE or directly. The laboratory specimen for newborn metabolic testing is collected within 24-48 hours of birth (prior to discharge). Data related to specimen and patient demographic is pre-populated on the test order form from the Birthing Facility EHR. The provider reviews, certifies and submits the test order via health information exchange (HIE) or directly to the laboratory. Specimen is sent to the laboratory. Laboratory sends electronic acknowledgement of receipt of the test order to the Birthing Facility EHR via HIE or directly. Laboratory conducts the metabolic test following jurisdiction-specific rules for metabolic screening. Depending on jurisdictional workflows, test result reports from the Laboratory Information Management System (LIMS) or other entities are sent to the EHR system or the Public Health Authority information system (e.g., genetics information system). The Public Health Authority information system <<Date>> 16 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative receives the Report from either LIMS or the provider EHR system and then sends electronic acknowledgement of receipt; transmission of information is performed via HIE or directly.4 Child Health A child with a caregiver comes to a provider for a well-child visit. The provider EHR queries HIE for information on the child and uploads appropriate information into EHR. EHR calculates that the child is due for a procedure (e.g., immunization, hearing test and others) and generates the notification to the provider with the standing order. Consent for procedure and Consent for information exchange is obtained from the caregiver. The provider and/or staff performs the appropriate procedure (or refers to a specialist) and enters information into the EHR. According to jurisdiction-specific laws, Public Health Reports on the procedure are generated in the provider EHR. The provider collects additional information needed for these reports and enters that information in the Reports. The provider reviews, electronically signs and submits the Reports via health information exchange (HIE) or directly to the Public Health Authority according to jurisdiction-specific laws. The Public Health Authority information systems (early hearing detection and intervention information system, birth defect registry, immunization information system) receive the Report and sends electronic acknowledgement of receipt to the EHR system via HIE or directly. 11.1.4 Adverse Events A patient receives healthcare services (e.g. administered medication or vaccine, surgical or diagnostic procedure) and the appropriate information (e.g., vital signs, lab results, medical product information, etc.) is entered or uploaded into the EHR system. Note that EHR data entry or upload may or may not be an automated process. When an adverse event occurs and determined to meet appropriate reporting criteria, the EHR system renders or generates an adverse event report. When necessary, the healthcare provider or other staff validates or certifies the accuracy and completeness of the report. When necessary, the healthcare provider or other staff enters additional information into the report. Upon successful verification and/or certification, the EHR system generates the adverse event report and sends it to the public health agency system or when appropriate, to another intermediate system (e.g., HIE, registry or incident reporting system). If applicable, the intermediate system sends the report to the public health agency information system. The public health agency or intermediate system receives the report and sends an electronic acknowledgement of receipt to the EHR system. It is important to note that this consolidated user story and supporting Appendix A provide a high-level description of public health adverse event reporting process. There are public health reporting user stories (e.g. Healthcare Associated Infection reporting) that present more complexities in specific reporting scenarios, for example, mandatory versus voluntary reporting requirements, and reporting of numerators and denominators for the specific conditions. These requirements are further clarified and 4 Note: direct reporting for a laboratory (or LIMS) to public health is out of scope for this phase of the Public Health Reporting Initiative. It may be considered in future versions. <<Date>> 17 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative captured during the analysis and discussion of detailed functional requirements for the use case, taking into account existing reporting processes and implementations. 11.1.5 Infrastructure/Quality/Research The user stories in the Infrastructure, Quality, and Research domain may have elements that are applicable throughout other stories submitted to this initiative. These user stories may be used/re-used by other stories in functional requirements and data modeling discussions. Infrastructure, Quality, and Research user stories are generally focused on quality reporting, administrative data reporting, and infrastructure. 11.2 Activity Diagram The sections below describe the high-level public health reporting activity flow. The diagram depicts both the primary and alternate reporting scenarios, where the report can be sent either directly from an EHR system to a public health agency system, or can be sent through an HIE or other intermediary system (e.g., incident reporting system or patient safety organization). The primary reporting flow (i.e., base flow) – the submission of a report from an EHR system directly to a public health agency – is depicted in the activity flow below in white boxes and black arrows. The alternate reporting flow – the submission of a report through intermediary system such as an HIE or Incident Reporting System – is depicted in the activity flow below using grey boxes and grey arrows. Both flows are further described in the following sections. <<Date>> 18 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative Electronic Health Record System Intermediary System Public Health Agency System (1) Generates and Sends report (2) Receives report (1a) Receives report (1b) Sends report (4) Receives acknowledgement of receipt (3) Sends acknowledgement of receipt (3a) Receives acknowledgement of receipt (3b) Sends acknowledgement of receipt Figure 2: Activity Diagram 11.2.1 Base Flow The base flow (primary reporting flow) describes the submission of a report to a public health agency directly from a healthcare provider EHR system. This flow assumes that an event of public health interest has been identified and meets pre-specified reporting criteria. Note that additional system interactions and acknowledgements will be described in additional documents, including the functional requirements and implementation specification. Step # Actor <<Date>> Role Event/Description Inputs Outputs 19 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative Step # 1 2 3 4 Actor Role Event/Description EHR System Generate and Send Report EHR System generates public health report and sends to public health agency system (Note: healthcare provider may verify/certify report prior to send) Public Health Agency System Public Health Agency System EHR System Receive Report Public Health Agency System receives report Send Acknowledge ment Public Health Agency System sends acknowledgement of receipt of report EHR System receives acknowledgement of receipt Receive Acknowledge ment Inputs Public health reporting criteria; report generated/sent when patient/healthcare data meets reporting criteria and appropriate report validation and certification processes are complete. Receipt of public health report Receipt of public health report Acknowledgement of receipt of public health report Outputs Public health report, including at a minimum all required data elements that meet the specified report type, in standardized structured format Program-specific outputs (out of scope for this document) Acknowledgement of receipt of public health report END Table 3: Base Flow 11.2.2 Alternate Flow In the alternate flow, a healthcare provider sends the report through an intermediary system (e.g., HIE, Incident Reporting System, Patient Safety Organization) to a public health agency. Note that there are various considerations for the HIE or other intermediaries, including possible requirements for routenot-read; privacy/security controls, including appropriate encryption of data; and the potential for the intermediary to generate a report based on data received in various systems. The full elaboration of these requirements is out of scope for the use case, and can be elaborated in the development of Functional and Information Exchange Requirements. Step # Actor <<Date>> Role Event/Description Inputs Outputs 20 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative Step # 1 Actor Role Event/Description Inputs EHR System Generate and Send Report EHR System generates public health report and sends to Public Health Agency System (Note: healthcare provider may verify/certify report prior to send) 1a Intermediary System Receive Report HIE System receives report 1b Intermediary System Send Report HIE System sends report to Public Health Agency System Receipt of public health report 2 Public Health Agency System Receive Report Public Health Agency System receives report Receipt of public health report 3 Public Health Agency System Send Acknowle dgement Receipt of public health report 3a Intermediary System Receive Acknowle dgement 3b Intermediary System Send Acknowle dgement 4 EHR System Receive Acknowle dgement Public Health Agency System sends acknowledgement of receipt of report to HIE system HIE System receives acknowledgement of receipt from Public Health Agency System HIE System sends acknowledgement of receipt to EHR system Healthcare provider receives acknowledgement of receipt from HIE system Public health reporting criteria; report generated/sent when patient/healthcare data meets reporting criteria and appropriate report validation and certification processes are complete. Receipt of public health report Outputs Public health report, including at a minimum all required data elements that meet the specified report type, in standardized structured format Public health report in standardized structured format. Public health report in standardized structured format Program-specific outputs (out of scope for this document) Acknowledgement of receipt of public health report Acknowledgement of receipt of public health report Acknowledgement of receipt of public health report Acknowledgement of receipt of public health report Acknowledgement of receipt of public health report Acknowledgement of receipt of public health report END Table 4: Alternate Flow <<Date>> 21 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative 11.3 Functional Requirements The functional requirements for this use case, which includes the data elements, terminology and data exchange standards requirements will be provided in a separate Functional Requirements Document. 11.3.1 Sequence Diagram The sequence diagram below depicts the system interactions between the EHR system, Intermediary System or Network and the Public Health Agency. Both the primary and alternate reporting flows are represented. Healthcare providers may send reports directly to a public health agency system or through an intermediary system or network. Electronic Health Record System Intermediary System Public Health Agency System Send Initial Case/Event Notification Send Initial Case/Event Notification Send Initial Case/Event Notification Send Acknowledgement Send Acknowledgement Send Acknowledgement Figure 3: Sequence Diagram 12.0 Policy and Regulatory Issues The primary policy issue at hand is the intention to converge the public health reporting rules into a single standard. Some hope to have a solution that fits all needs, even as others recognize the inherent differences between local laws and policies that may have disparate requirements. For example, one jurisdiction may not be able to request date of birth and store age in their system instead, whereas another may in fact be required by law to collect date of birth. The Public health reporting criteria are based on specific jurisdictional or public health agency requirements and may vary from condition-tocondition or jurisdiction-to-jurisdiction. Reporting to public health agencies is most often governed by state statutes, regulations and policies that are different than what governs other types of health information exchange. While Health Insurance Portability and Accountability Act (HIPAA) regulations are the primary determinant of privacy protections for most health information exchange (or statutes in states that exceed HIPAA regulations), <<Date>> 22 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative reporting to public health agencies is generally exempt from HIPAA regulations, governed instead by a patchwork of state statutes, regulations and policies. However, as was learned in the multiyear Health Information Security and Privacy Collaborative, interpretation and implementation of even national regulations such as HIPAA can vary considerably within the same state. So, inconsistent regulations and policies around health information exchange, including public health reporting, appear to be a given in this country. This can certainly be seen as a reflection of the level of care and caution being exercised around privacy protections and health information exchange, which is entirely appropriate. Earning ongoing public trust in health information exchange, including public health reporting, is critical to achieving the HITECH and broader e-health goals in this country. However, the public health community is increasingly questioning whether the degree of interjurisdictional variation in privacy protections and especially reporting regulations are necessary. This use case provides an opportunity to explore areas of similarities and differences in reporting requirements that could contribute to greater harmonization over time. However, it is important to keep in mind that state statutes and regulations are only changed through often lengthy and complex public processes and occur on a state-by-state basis. Federal preemption of state privacy laws and regulations is highly unlikely (except for periodically establishing the floor as was done with HIPAA). Harmonizing other policies, such as establishing core data elements for particular public health domains, is much more under the control of the professional domains, and so amendable to cross-domain harmonization. <<Date>> 23 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative Appendices Appendix A: User Stories The Initiative received user stories from the community and worked with the community to consolidate the submissions around five general Public health domains – communicable disease; chronic disease; child health; adverse events; and infrastructure, quality, and research. Each domain-area consolidated user story is presented below, with the following elements: User story names – the names of the individual user stories that contributed Actors – the actors involved in the consolidated story Flow of events – the high level flow of events across the consolidated user story Information exchange artifacts – identifies the data/content that the report should contain (e.g., paper form content or dataset/class) Pre-conditions – the system(s) that creates/sends reports Post-conditions – the system(s) that receives reports Preferred timing – desired frequency of reporting (if applicable) Communicable Disease Consolidated User Story (Reporting from EHR system) User Story Names: Provider-Initiated Report from the EHR system (Communicable Diseases) Actors: Patient, Healthcare Provider (Hospital, Physician’s office), Laboratory, Public Health Agency Flow of Events: 1. 2. 3. 4. 5. Patient was admitted to a hospital, emergency room (ER), or came to a provider’s office Provider provided clinical examination and assessed medical history a. [trigger: all Emergency Department records sent] If provider assessment indicates that Patient has symptoms that should be reported through Syndromic Surveillance (SS) system, a SS repot was sent to public health agency. Electronic confirmation was sent from public health agency system to provider. b. [trigger: clinically significant symptoms of reportable communicable disease – sent before lab results are obtained] If patient’s symptoms require a specific communicable disease public health report without waiting for laboratory results, a preliminary report was sent to public health agency. Provider orders lab tests. Laboratory performs ordered tests on received specimens. Laboratory sends results to Provider and public health agency (if needed) Provider re-examines clinical findings and lab results; he sends a communicable disease preliminary report to a public health agency (some reports require clinical and <<Date>> Information Exchange Artifacts Provider information Ordering facility Patient information Patient employment Clinical information Laboratory test order/result Additional epidemiologic data 24 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative 6. 7. lab component) Electronic message validated by public health agency information system. Electronic confirmation sent from public health agency to provider. Sending System(s): EHR System, Health Information Exchange (HIE) Receiving System(s): Public Health Agency Information Systems Preferred Timing: It is important to note that the above description provides a basic description of communicable disease reporting processes. There are public health reporting user stories (e.g. Healthcare Associated Infection reporting to CDC’s National Healthcare Safety Network) that present more complexities in specific reporting requirements, including the reporting of numerator and denominators for the specific conditions. These types of requirements may be captured in the analysis of functional requirements, data elements and value sets for specific reporting implementations. Chronic Disease Consolidated User Story #1 User Story Names: cancer, occupational health, future flow for National Center for Health Statistics (NCHS), genetic counseling Actors: Patient, Healthcare Provider/Physician, Laboratory, Public Health Agency Flow of Events: 1. 2. 3. 4. 5. 6. 7. Patient comes to Physician at specific healthcare facility with symptoms of a disease or for a check up Physician provides clinical examination and assesses medical history. Physician orders lab (clinical or pathology) and any diagnostic tests. Physician discontinues, changes, and/or orders new medications and/or services and/or consultations/referrals Any other diagnostic tests are performed and Laboratory performs ordered tests on received specimens. Laboratory send results to Physician [and Public Health Agency for reportable conditions] Physician re-examines clinical findings/diagnostic results and lab results and diagnoses reportable condition, treats patient, including discontinues, changes and/or orders new medications and/or services and/or consultations/referrals and/or new lab tests based on previous results <<Date>> Information Exchange Artifacts Provider Info Demographic patient info Diagnosis Payer information Encounter information Medical history Family history Procedures Results of testing (lab and otherwise) Risk factors Exposure information Occupational information Employer information Medications 25 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative 8. 9. 10. 11. 12. 13. Physician completes counseling session, if applicable IT personnel combines EHR patient discharge data with Hospital billing data, if applicable Physician/EHR system sends report to a Public Health Agency for reportable conditions Electronic report validated by Public Health Agency information system EHR system sends a CCD/CCR electronic ‘snapshot’ of the episode of care to Health Information Exchange agency Electronic confirmation/acknowledgement was sent from Public Health Agency to Provider Sending System(s): EHR System Receiving System(s): Public Health Agency Information Systems Preferred Timing: Varies currently – prefer real time <<Date>> 26 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative Chronic Disease Consolidated User Story #2 User Story Names: Quality, NCHS current flow, Cardiovascular Disease (CVD) Actors: Patient, Healthcare Provider/Physician/healthcare facility, billing staff, PH authority Flow of Events: 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Patient admitted to specific healthcare facility Billing creates Public Health report based on status Physician provides clinical examination and assesses medical history. Physician orders lab (clinical or pathology) and any diagnostic tests. Nursing or ancillary staff takes samples and sends them to Laboratory. Physician discontinues, changes, and/or orders new medications and/or services and/or consultations/referrals Any other diagnostic tests are performed and Laboratory performs ordered tests on received specimens. Laboratory send results to Physician [and Public Health Agency for reportable conditions] Physician re-examines clinical findings/diagnostic results and lab results and diagnoses reportable condition, treats patient, including discontinues, changes, and/or orders new medications, and/or services, and/or consultations/referrals, and/or new lab tests based on previous results Patient is discharged from specific healthcare facility Billing system or clearing house sends report/discharge claim records to a Public Health Agency Electronic report validated by Public Health Agency /information system Electronic confirmation/acknowledgement was sent from Public Health Agency to Provider Information Exchange Artifacts Provider Info Demographic patient info Diagnosis Payer information Case details (clinical symptoms etc.) Procedures Results of testing (lab and otherwise) Risk factors Exposure information Occupational information Employer information Medications Sending System(s): Billing system within the EHR System Receiving System(s): Public Health Agency Information Systems Preferred Timing: For CVD: Admit – 5 days after admit and 24 hours after billing code assigned For NCHS: Discharge – preferred quarterly (accepted monthly or 24 hours) For Quality: patient encounter is completed - quarterly <<Date>> 27 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative Child Health Consolidated User Story – Birthing Facility User Story Names: Vital Records, Hearing, Immunization, Birth Defects, Metabolic Screening Actors: Newborn, Caregiver, Provider, Hospital staff, Public Health Program Staff Flow of Events: 1. Child is delivered. 2. Provider conducts initial physical exam and assessment for birth defects. If live birth, follow steps 3-9. If fetal death, follow steps 7-9. 3. Newborn is due for <immunization, hearing test, metabolic test, other newborn tests, birth registration, etc.> Provider obtains consent for procedure and information exchange from caregiver. 4. Provider orders an <immunization, hearing test, metabolic test, additional birth defect testing, etc.> 5. Hospital staff administers <immunization> and conducts <hearing test> and collects <blood specimen> and conducts <birth defect testing> 6. Hospital staff enter data on the <immunization, hearing test, birth defects, lab order> into the EHR. EHR generates public health report 7. EHR system pre-populates information to the Birth/Fetal Death Facility Worksheet 8. Hospital staff and provider review/electronically signs the Birth/Fetal Death Facility Worksheet and public health report 9. Public health report is electronically sent on <immunization, hearing test, metabolic test order, birth defect, birth registration/fetal death registration, etc.> to the appropriate public health information systems as jurisdictionally defined directly or via HIE 10. Public Health Authority information system (IS) <Immunization IS, Early Hearing Detection & Intervention (EHDI) IS, Metabolic IS, Birth Defect IS, Vital Records IS> receives notification of report availability 11. Public health authority staff reviews the report and create public health IS record on a child in <Immunization IS, EHDI IS, Genetic IS, Birth Defect IS, Vital Records IS> 12. Public health IS sends Acknowledgement of Receipt of the Report to EHR system directly or via HIE. Information Exchange Artifacts 1&2 Demographics, Antepartum Record, Prenatal record, Labor & Delivery Record, Postpartum record, Newborn EHR 3. Consent for procedure as jurisdictionally defined (not for birth registration) and Consent for information exchange 4. Test Order or Standing Order 5. Immun. Record, Test Results, Birth Defect Record 6. Immun. Record, Hearing Test Results, Birth Defect Record, Birth Record, Lab Order 7&8. Birth/Fetal Death Facility Worksheet 9. Public health report <immunization, hearing test, metabolic test order, birth defect, birth registration/fetal death registration, etc.> 10. Notification of Report Availability 11. Updated public health record 12. Acknowledgement of receipt Sending Systems: EHR System, Health Information Exchange (HIE), other Intermediary System Receiving Systems: Public Health Information Systems <Immunization IS, EHDI IS, Birth Defect IS, Vital Records IS, Genetic Testing IS, etc.> Preferred Timing: Daily updates <<Date>> 28 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative Child Health Consolidated User Story – Outpatient Setting User Story Names: Child Health <Immunization, EHDI> Actors: Child, Pediatrician, Provider, Specialist, Public Health program staff Flow of Events: 1. Child with caregiver comes to pediatrician for a well-child care visit (general check-up) and he/she is due for <immunization, hearing test, etc.> Provider obtains consent for procedure and information exchange from caregiver. 2. Physician orders <immunization> or refers to an Audiologist <hearing test> or a Specialist <other tests> 3. Provider administers an immunization; Audiologist conducts hearing test 4. Provider/Audiologist enter data on the <immunization, hearing test> into the EHR 5. EHR system generates public health report 6. Provider review/electronically signs the public health report 7. Public health report is electronically sent on <immunization, hearing test> to the appropriate public health information systems as jurisdictionally defined directly or via HIE 8. Public Health Authority information system (IS) <Immunization IS, Early Hearing Detection & Intervention (EHDI) IS > receives notification of report availability 9. Public health authority staff reviews the report and updates the public health IS record on a child in <Immunization IS, EHDI IS> 10. Public health IS sends Acknowledgement of Receipt of the Report to EHR system directly or via HIE. Sending Systems: EHR System, Health Information Exchange (HIE) Receiving Systems: Public Health Information System <Immunization IS, EHDI IS> Preferred Timing: Daily updates <<Date>> Information Exchange Artifacts 1. Demographics, Consent for procedure as jurisdictionally defined and Consent for information exchange 2. Test Order, Referral 3. Immunization Record. Test Results 4. Test Results 5,6 & 7 Public health report 8. Notification of Report Availability 9. Updated public health record 10. Acknowledgement of receipt 29 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative Adverse Events Consolidated User Story User Story Names: Actors: Healthcare Provider Reporting; Agency for Healthcare Research and Quality (AHRQ) Common Formats; American Immunization Registry Association (AIRA); Food and Drug Administration (FDA) Adverse Event Reporting; CDC’s National Healthcare Safety Network (NHSN) Information Exchange Artifacts Patient, Healthcare Provider (HCP), Immunization Registry, Public Health / Patient Safety Organization Flow of Events: 1. 2. 3. 4. 5. 6. 7. Surveillance parameters are programmed into an EHR system based on specific jurisdictional or Public Health Agency requirements (e.g., Liver function test, or serious adverse event) A patient receives healthcare services and information is uploaded to the HCP EHR (e.g., vital signs, lab results, etc.) via manual data entry, HCP PDA-device or other EHR data interface When the surveillance criteria is met, an adverse event report form is automatically rendered for HCP review Report form is auto populated with appropriate patient and event information based upon jurisdictional or Public Health Agency requirements HCP validates completeness of report and make adjustments as necessary (e.g., add reporter’s comments) HCP local system (EHR system or Incident Reporting System) sends report to Public Health Agency Public Health Agency sends acknowledgement to HCP local system that report was received Patient Demographics Relevant Medical History and Lab: pre-existing conditions, diseases, tests, procedures Adverse Event Information: date, time, adverse event description and patient outcome Product Information: suspect and concomitant medications, medical devices, other therapies, dates of use, indication, dose, strength, name, identifiers, etc. (Reference specific FDA reporting form, AHRQ Common Format Template, NHSN Implementation Guide and Immunization information system implementation guide) Reporter Information: name, address, telephone/email, and facility contact information Note: Data categories are unique to the specific program and datasets/data elements are available for reference. Sending System(s): RSS System, Laboratory information system, EHR System, Incident Reporting System Receiving System(s): Public Health Agency Information Systems or Patient Safety Organization’s Information System Preferred Timing: Varies depending on jurisdictional or Public Health Agency requirements. <<Date>> 30 Use Case Development and Functional Requirements for Interoperability Public Health Reporting Intiative Appendix B: Acronyms Acronyms used in the document are identified in the table below. Term Agency for Healthcare Research and Quality American Immunization Registry Association American Recovery and Reinvestment Act of 2009 Centers for Medicare and Medicaid Services Early Hearing Detection and Intervention Electronic Health Record Electronic Medical Record Emergency Room Food and Drug Administration Health Information Exchange Health information technology Health Information Technology for Economic and Clinical Health Act of 2009 Health Insurance Portability and Accountability Act Healthcare Provider Information System Laboratory Information System Laboratory Results Interface Workgroup Meaningful Use Office of the National Coordinator for Health Information Technology Personal Health Record Public Health Laboratory Reporting Workgroup Public Health Reporting Initiative Standards & Interoperability Framework Acronym AHRQ AIRA ARRA CMS EHDI EHR EMR ER FDA HIE HIT HITECH Act HIPAA HCP IS LIS LRI Workgroup MU ONC PHR LRI Public Health Workgroup PHRI S&I Framework Appendix C: Glossary of Terms A glossary of terms has been developed for the Public Health Reporting Initiative. These terms and their definitions are available as a word document through the S&I Framework wiki. A more extensive excel spreadsheet detailing these terms, their definitions, and reference sources is also available. Visit http://wiki.siframework.org/PHRI+-+Definitions+Sub-Working+Group to access these resources. <<Date>> 31