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H1N1 Disease Surveillance: The Information Architecture for County Public Health Services MED INF 405 – Team Project Paper Team Members Melody Dungee Beena Joy David Medina Calvin Palmer H1N1 Disease Surveillance MED INF 405 – Team Paper CONTENTS Overview............................................................................................................................... 1 Problem ....................................................................................................................................................................................... 1 Project Objective ...................................................................................................................................................................... 2 Stakeholders ......................................................................................................................... 2 Description of Stakeholders ................................................................................................................................................ 2 Stakeholder Interests............................................................................................................................................................. 2 Business Case ........................................................................................................................ 3 Workflow .............................................................................................................................. 4 Actors............................................................................................................................................................................................ 4 People..................................................................................................................................................................................................4 System .................................................................................................................................................................................................4 Current State - Paper-based reporting ........................................................................................................................... 5 Problems ............................................................................................................................................................................................5 Future State – NEDSS-based biosurveillance system ............................................................................................... 6 Benefits...............................................................................................................................................................................................8 Workflow Scenarios ............................................................................................................................................................... 8 Laboratory alert: H1N1 test order ........................................................................................................................................8 Laboratory alert: H1N1 test results (preliminary/final) ...........................................................................................8 Web-based H1N1 Biosurveillance Document entry ................................................................................................... 11 CIS Generated Biosurveillance document ....................................................................................................................... 13 System Requirements .......................................................................................................... 15 Standards ............................................................................................................................ 16 Use of standards and specifications by systems actor ........................................................................................... 16 Description of standards and specifications .............................................................................................................. 18 Usage example of standard (HITSP/C37).................................................................................................................... 20 Example of a HITSP/C37 Message from LIMS to CPHS ............................................................................................ 20 HITSP/C37 Lab Report Document Component Specification ................................................................................ 20 HITSP/C37 Data Structure .................................................................................................................................................... 20 Information Architecture ..................................................................................................... 22 Data Sets ............................................................................................................................. 23 Data Element Constraints .................................................................................................................................................. 23 Definition of individual data elements ......................................................................................................................... 23 Demographics .............................................................................................................................................................................. 23 Clinical Data (Signs, Symptoms) ......................................................................................................................................... 23 Medical History ........................................................................................................................................................................... 24 Diagnostic Findings ................................................................................................................................................................... 24 Treatment ...................................................................................................................................................................................... 25 Epidemiology................................................................................................................................................................................ 25 Data set sources ..................................................................................................................................................................... 25 Data flow diagram ................................................................................................................................................................. 30 H1N1 Disease Surveillance MED INF 405 – Team Paper Overview County Public Health Services (CPHS) is the local agency responsible for public health activities in Sickly Falls, TX. CPHS conducts a number of public health related activities such as health monitoring, community health education, health policy development, operation of essential community health services, investigation of potential community health problems as well as other public health services as directed by law. One of the most important public health responsibilities facing CPHS is that of local disease surveillance. In the context of public health, the intent of surveillance can be summed up in the following phrase: “Information for Action.” This is further defined as “…ongoing systemic collection, collation, analysis and interpretation of data and the dissemination of information to those who need to know in order that action may be taken.”i Effective surveillance will depend upon a robust disease surveillance and response system that will promote better coordination and integration of the surveillance functions across the various stakeholders in the local community. According to the World Health Organization, pandemic influenza A (H1N1) is now the predominant flu strain circulating in most areas across the globe. The U.S. is expected to conform to this trend, as the number of new cases seems to be expanding in the northern hemisphere. In addition, the consequences of a potential pandemic may prove to be staggering to the health the U. S. population. For example, according to the President’s Council of Advisors on Science and Technology, in 2009 H1N1 may infect almost one half of the U.S. population, requiring 1.8M hospitalizations and result in 30,000 to 90,000 deaths.ii As a consequence, H1N1 surveillance has become a priority of Sickly Falls, TX and County Public Health Services. Problem According to the Associated Press, U.S. health officials have decide not to mount a nation effort to count cases of swine flu, instead “The Centers for Disease Control and Prevention is relying on a patchwork system of gathering death and hospitalization numbers. Some states are reporting lab-confirmed cases. Others report illnesses that could be the new swine flu, seasonal flu or some other respiratory disease.”iii As a result, in order to determine the potential spread of H1N1 infection in the local community, CPHS will need to develop a method to monitor for a potential disease outbreak. Currently, there is no mechanism for detecting and monitoring the spread of H1N1 disease in the local community. CPHS has decided to address this issue by capitalizing on the fact that most local healthcare providers and service organizations (e.g., laboratories, etc.) utilize or have access to some sort of electronic medical record, reporting system or even access to the Internet. To support H1N1 disease surveillance, CPHS will need to design an information architecture that will enable the integration, and analysis, of local records and data sources. 1 H1N1 Disease Surveillance MED INF 405 – Team Paper Project Objective The overriding objective of this project is to develop an information architecture that will integrate the data sources of healthcare providers, service providers and other stakeholders in Sickly Falls, TX. This information will be integrated into a central data source at CPHS, which can provide early warning of an outbreak, through alerts, and can be analyzed to provide insights into disease vectors, high-risk populations and other information, which may be of value to CPHS in developing public health policy. Stakeholders Description of Stakeholders State and Local Public Health Departments – are entities developed with the sole purpose of protecting the health of state and local communities Community Members – are key players in the well being of all defined stakeholders Businesses – are the mainstay of any community. Any disruption in services would directly affect the local community Charities (homeless shelters, etc.), faith-based organizations, educational institutions, day care, hospitality – are entities dedicated to assisting community members their financial base is largely contributed to by community, business, and government agencies. Any disruption with those 3 providers would cause negative financial consequences as well workforce. Local Hospitals/Clinics and physicians - provide services needed to care for an affected H1N1 population Local healthcare provider organizations – would be indirectly affected; may need to handle overflow from hospital, clinics, or physicians Labs and pharmacies – would be needed to diagnose H1N1 and to provide needed medication treatment Long-term and ancillary care – this population is one of the targeted high-risk groups for fatalities if infected with H1N1 Local Government Organizations – would be utilized to help obtain bureaucratic assistance if needed Fire and Police Departments, Red Cross, Local Agencies - might be called upon to assist in an outbreak Stakeholder Interests 2 State and Local Public Health Departments – In the event of an H1N1 outbreak, the local and state public health departments would be the main organization utilized to obtain vaccinations and to retrieve needed treatment information. Community Members - may be called upon to help to fill positions of affected stakeholders in an effort to keep the community operating as normal. Business - an unreported H1N1 outbreak would cause financial losses to not only local businesses but also the financial well being of the local community H1N1 Disease Surveillance MED INF 405 – Team Paper Charities (homeless shelters, etc.), faith-based organizations, educational institutions, day care, hospitality - these facilities have limited resources and any disruption in “normal” workflow could be catastrophic to these organizations Local Hospitals/Clinics and physicians – would treat affected patients and as such would be one of the main stakeholders in an H1N1 outbreak. Local healthcare provider organizations – may be called upon to handle “overflow” of patients if the hospital has no more room. Labs and Pharmacies – would provided services to diagnose and treat patients, respectively Long-term care and ancillary care – are high-risk groups that need to be notified as soon as an outbreak is detected in an effort to keep this group safe Local Government Organizations – would be the path needed to obtain emergency services at a state or federal level Fire and Police Departments, Red Cross, Local Agencies – would be used to keep community members “under control” and to assist as needed Business Case The business case for developing the information architecture for an H1N1 surveillance program is fairly straightforward and, if successful, will address the following problems: Monitor and reduce the spread of H1N1 disease in the local community Determine the required data sources and the integration issues that must be addressed by the information architecture Enable analysis of H1N1 surveillance data o Determine risk factors (ID high risk groups) for prediction and control o Enable development of prevention strategies This project can be justified from two perspectives: financial and the regulatory responsibilities of a public health organization. From a financial perspective the issues include the following: Reduce cost of medical care (i.e., estimated 1.8M hospital admissions, etc.) Effect on U.S. business o Absenteeism - 84% of business concerned H1N1 outbreak will adversely affect their business o 67% of respondents replied that they would note operational problems if 50% of workforce off for more than 2 weeksiv As a public health agency CPHS has a number of regulatory mandated responsibilities that will require the completion of this project in order to be completed. These responsibilities include the following: 3 Guide the development of decisions regarding the local public health response Guide the formulation of local public health policies Evaluate effectiveness of local public health programs for H1N1 H1N1 Disease Surveillance MED INF 405 – Team Paper HIPAA issues should not be a major factor in the development of this information architecture as CPHS is considered a public health authority as defined by HIPAA, 45 CFR 164.501, where a public health authority is defined as “an agency or authority of…, a State,…, or a political subdivision of a State…, that is responsible for public health matters as part of its official mandate.” 45 CFR 164.512(b) allows covered entities to disclose protected health information to public health authorities. From a business case point of view the goals and objectives of this project are as follows: Identification and integration of all data sources needed for effective H1N1 surveillance Be able to identify potential H1N1 cases in near real-time Improve timeliness and accuracy of communications regarding H1N1 virus in the local community Communicate potential H1N1 cases to community epidemiologists within 24 hours of confirmed H1N1 cases Provide sufficient information for local authorities to develop local mitigation strategies Avoidance of projected H1N1 infection rates Based on President’s Council of Advisors on Science and Technology Report Workflow H1N1 surveillance activities: Cases may be reported from a variety of sources from within the health care setting, such as clinical laboratories and private physicians. This data is then collected, managed, transmitted, analyzed, accessed and disseminated. Actors People Clinician – Any healthcare provider who has direct patient interaction in the delivery of care including physicians, nurses and clinical supervisors. They are involved in the evaluation of patients and the entry of source data and clinical information into the system. Public Health Officials – These actors are the staff of County Public Health Services (CPHS) who are responsible for interacting with the biosurveillance system for indications of H1N1 infection. System 4 Laboratory Information System (LIMS) - A laboratory information system that supports the testing, analysis and data management for a clinical or pathology laboratory. These laboratories can either be independent clinical laboratories, physician office laboratories or hospital-based laboratories. Clinical Information Systems – Any information system (EMR, EHR or PHR), which supports the clinical care information management needs either of hospitals, inpatient H1N1 Disease Surveillance MED INF 405 – Team Paper organizations, ambulatory care (e.g., community physician offices), outpatient or emergency care organizations. County Public Health System – This is the regional public health authority tasked with tracking H1N1 disease in Sickly Falls, TX. CPHS Biosurveillance System – This is the central data store and application used by CPHS for entry, management and querying of the demographic and diseases data. Based on the NEDSS system software, it provides a mechanism for web-based data entry, electronic interchange of laboratory data, storage and maintenance of data, query and reporting capabilities. Current State - Paper-based reporting Current paper-based data collection system The current biosurveillance system is a voluntary, paper-based process where a clinician or laboratory that has a suspected or confirmed H1N1 diagnosis completes a paper biosurveillance form and submits it to the CPHS either by fax or by mail. Not only is this process cumbersome and time consuming, resulting in lag-times for the reporting of potential H1N1 cases, but, it also severely limits the speed at which any practical use can be made of the data. The current state of biosurveillance is rife with problems. Problems The current biosurveillance system is burdened by many problems that will not allow the system to be useful for H1N1 disease surveillance, where rapid recognition of H1N1 infection coupled with near-real time analysis is the key to an effective response that may avoid an H1N1 disease outbreak. 5 Data Collection – Data collection places a large burden on medical care staffs that have responsibility for disease reporting. It is often left up to health care providers to determine if a case meets public health surveillance case definitions and to figure out how to fill out the wide variety of forms produced by CDC and health departments. The other element that impedes data collection is that staff must spend significant time tracking down patient records in response to requests for more information from the health department. v H1N1 Disease Surveillance MED INF 405 – Team Paper Data management issues – The issues around data management can also impede effective reporting. Some of the more significant data management problems include: o Multiple case reports - Given the number of potential information sources for a single patient, patients may be entered into the system more than once or have discrepant data reported in different systems. o Data entry at the health departments – CDC has created multiple data entry systems for local and State health department data. As a result an individual person must be entered into multiple, disparate systems. Unfortunately, each of the CDC systems works differently, so that using more than one of them is onerous and time consuming.v Data Transmission - There are many different methods for reporting data to CPHS, the state health department or the CDC. Examples include mailing of diskettes, or transmitting data via dial-up modems or wide area network (WAN) or using the Internet for reporting. All of these methods are currently in place just for reporting to CDC. Security - In terms of electronic encryption methods, different levels of security are being applied. For example, in a recent inventory, over 73 different surveillance systems developed at CDC sent or received surveillance data electronically. Only 19, however, reported encrypting the data for transmission.v Future State – NEDSS-based biosurveillance system In order to meet the requirements for local surveillance of H1N1 influenza cases, and facilitate the handling and analysis of data, CPHS will develop a local biosurveillance system modeled on the National Electronic Disease Surveillance System (NEDSS) Base System. This system will have a number of features intended to address and fix the previously identified problems in the current biosurveillance system. 6 Data Collection – The new system should improve data collection practices by establishing standards to enable uniform data collection practices in the local area. These include a minimum set of demographic data that should be collected as part of the routine surveillance, as well as standardizing data collection forms in order to provide a consistent method of data coding. It will also provide a standard data architecture and electronic data interchange format that will allow computer systems to automatically generate electronic case reports, which will be transmitted to CPHS or forwarded on to the state health department. v Data Management - Duplication – The NEDSS system will provide data registry matching based on reliable record matching software components and tools, that can be used at the local and State health department levels to detect duplicate reports based on a person’s demographic data (e.g., name, address, date of birth, sex) and identify discrepant data. Data Management – Data entry at the health department - Information is entered and stored in a consistent and uniform way in the CPHS system, which means that it can be easily transferred between systems thereby reducing duplicate data. Using the NEDSS- H1N1 Disease Surveillance MED INF 405 – Team Paper based system, with the user interface of CDC-developed surveillance systems allows a person trained on any one system to be able to move to another without changing the way they interact with the software. Data Transmission - from Local to State Health Department to CDC – A NEDSS-based system will allow for the use of the CDC’s Health Alert Network (HAN), employing the Internet as a backbone, to communicate surveillance data, reports, training materials, policy documents, etc., between health departments and CDC. It will also allow for CPHS to connect with other local health departments or other organizations critical for preparedness and response, such as community first-responders, hospital and private laboratories, state health departments, CDC, and other federal agencies.vi Secure Data Network - HAN also provides a secure method for encrypting and transferring files from a health department to a CDC program application across the Internet. This provides the benefits of eliminating the multiple methods of receiving data and providing a consistent, transparent method for authenticating the data source and its integrity. Easing data analysis - Data collected in different surveillance and information systems such as laboratory based system or an immunization registry will afford better analysis since having standardized definitions for data elements will help ensure the correct interpretation of data elements. Data access and dissemination – The system will provide for data access, analysis and dissemination, primarily using data warehouses. This access will provide the following benefits: v o Responds to requests for information by State health departments, other Federal and State agencies, non-profit organizations, and news media in a timely fashion. o Strengthens local health departments and their links to critical community health organizations to form a coordinated public health response to H1N1. Data Access and Dissemination Through a NEDSS-based System 7 H1N1 Disease Surveillance MED INF 405 – Team Paper Benefits Implementing a NEDSS-based system will provide some key benefits, as it will enforce the use of standards. The use of standards will assure that surveillance data is easily shared, that users familiar with one system can easily use another, and that software can be easily shared across programs. Standards will serve as the framework that will provide integration for collection, management, transmission, analysis, and dissemination of data, thereby ensuring that all cases that are in the provider’s data systems are being reported correctly to local, state and federal agencies in a secure manner. Workflow Scenarios There are four workflow scenarios that will be considered in the development of the information architecture, which are laboratory orders, laboratory results, direct data entry into the CPHS system, and an EMR generated biosurveillance document. Although there may be other scenarios that could be considered, it is felt that these comprise the most common ones. A description of each scenario along with a process flow diagram should help clarify how these scenarios will work out. Laboratory alert: H1N1 test order A clinical information system (CIS), which can either be an EHR or EMR, generates a laboratory order for an H1N1 virus clinical lab test. This lab test order is then passed on to CPHS Public Health Officials, via the local laboratory LIMS, to alert them of a potential H1N1 case. Knowledge of H1N1 tests being ordered can be used as an early warning signal of potential H1N1 cases. 1) Patient presents with flu-like symptoms 2) Clinician documents history and physical in CIS (data is captured as discrete elements) and suspects H1N1 infection 3) Clinician orders H1N1 test: a. Utilizes CIS if applicable, or b. Utilizes laboratory supplied system 4) Lab order is automatically sent to the LIMS a. If via CIS, then via HL7 interface 5) Laboratory LIMS recognizes lab test code for H1N1 virus test 6) Laboratory LIMS sends alert message via Hl7 interface CPHS Biosurveillance system 7) CPHS Biosurveillance system receives notification of potential H1N1 case 8) CPHS receives alert confirmation of H1N1 case 9) CPHS contacts clinician for confirmation and details of patient encounter Laboratory alert: H1N1 test results (preliminary/final) A positive H1N1 test result would alert CPHS of a confirmed case of H1N1 flu. Information from a positive H1N1 test would automatically be transmitted to CPHS. 8 H1N1 Disease Surveillance MED INF 405 – Team Paper 1) Lab order is resulted and transmitted to CPHS via HL7 interface 2) Lab order is resulted and automatically updates the patient’s record in the CIS and alerts clinician of lab results (in red, if positive) 3) If positive test result, HITSP/C35, HITSP/C36, HITSP/C37 message sent to CPHS Biosurveillance system 4) CPHS receives H1N1 positive test result confirmation 5) CPHS contacts clinician for confirmation and details of patient encounter 6) Clinician is alerted either via email or telephonically and provides details to CPHS The following diagram illustrates both of these workflows: 9 H1N1 Disease Surveillance MED INF 405 – Team Paper H1N1 Biosurveillance – Laboratory Alert (Workflows 1 & 2) Clinical Information Clinician/Provider System (EMR/ HER) Laboratory Information Management System CPHS Biosurveillance System County Public Health System Test order processed and transmitted to CPHS Receives notification H1N1 test order Receive notification of potential H1N1 case CPHS receives positive result Receive H1N1 confirmation Patient presents with potential symptoms Clinician Suspects H1N1 Infection Yes No Clinician orders H1N1 test Yes EMR Entry Clinician / provider treats patient Clinician receives H1N1 test result H1N1 Test Processed H1N1 test result Positive result Yes No End Clinician / Provider provides details 10 Contacts clinician/ provider for confirmation and details H1N1 Disease Surveillance MED INF 405 – Team Paper Web-based H1N1 Biosurveillance Document entry The CPHS Biosurveillance system has a web-based entry NEDSS Base System is used to complete a biosurveillance document with the requisite demographic and H1N1 disease data through the NEDSS web-based portal. This situation would occur in cases where neither the laboratory LIMS or clinician’s CIS have the capability of automatically transmitting HITSP messages. The web-based system will transmit completed forms to a central data hub at CPHS alerting CPHS of a confirmed case of H1N1. 1) Patient presents with flu-like symptoms 2) Clinician documents history and physical in CIS (data is captured as discrete elements) and suspects H1N1 infection (yes) 3) Clinician orders H1N1 test: a. Utilizes CIS if applicable, or b. Utilizes laboratory supplied system 4) Lab order is automatically sent to the LIMS a. If via CIS, then via HL7 interface 5) Lab order is resulted and automatically updates the patient’s record in the CIS and alerts clinician of lab results in red, if positive. 6) Clinician gives patient diagnosis of H1N1 and enters it into the EHR (data is captured as discrete element) 7) Clinician treats patient and documents it into the CIS (data is captured as discrete element) 8) Clinician completes web-based NEDSS form and transmits electronically to CPHS 9) CPHS NEDSS Biosurveillance system receives electronic form of H1N1 case 10) CPHS is alerted of new H1N1 case. 11) Clinician is contacted by CPHS for validation of details The following diagram illustrates the workflow for a biosurveillance document entry. 11 H1N1 Disease Surveillance MED INF 405 – Team Paper H1N1 Biosurveillance – Web-based NEDSS Dcoument Entry Laboratory Information Management System Clinician/Provider CPHS Biosurveillance System County Public Health System Receive completed H1N1 form CPHS alerted of new H1N1 case Patient presents with potential symptoms Clinician Suspects H1N1 Infection Yes No Clinician orders H1N1 test Clinician / provider treats patient Clinician receives H1N1 test result Yes Test order processed and transmitted to H1N1 Test Processed H1N1 test result Positive result No Yes End Complete webbase NEDSS form 12 H1N1 Disease Surveillance MED INF 405 – Team Paper CIS Generated Biosurveillance document This scenario involves the automatic generation of a biosurveillance document for H1N1 disease from the Clinical Information System (EMR, EHR). This document will transmit completed forms to a central data hub at CPHS alerting CPHS of a confirmed case of H1N1. 1) Patient presents with flu-like symptoms 2) Clinician documents history and physical in CIS (data is captured as discrete elements) and suspects H1N1 infection (yes) 3) Clinician orders H1N1 test: a. Utilizes CIS if applicable, or b. Utilizes laboratory supplied system 4) Lab order is automatically sent to the LIMS a. If via CIS, then via HL7 interface 5) Lab order is resulted and automatically updates the patient’s record in the CIS and alerts clinician of lab results in red, if positive. 6) Clinician gives patient diagnosis of H1N1 and enters it into the CIS (data is captured as discrete element) 7) Clinician treats patient and documents it into the CIS (data is captured as discrete element) 8) Administrator runs a query report based on the discrete data elements documented by the clinician and lab results of one or all of the following: a. “Patients with a respiratory illness with a positive test result of H1N1” b. “Patient with a respiratory illness who expired with a negative test result of H1N1” c. “Patients without a respiratory illness with a positive test result of H1N1” 9) Report is exported from EHR and electronically sent to CPHS NEDSS Biosurveillance system as discrete data 10) CPHS is alerted of H1N1 case 11) CPHS contacts clinician for confirmation and details of patient encounter 12) Clinician is alerted either via email or telephonically and provides details to CPHS The following diagram illustrates the workflow of an EMR-generated biosurveillance document. 13 H1N1 Disease Surveillance MED INF 405 – Team Paper H1N1 Biosurveillance – CIS Alert (Workflow #4)) Clinical Information Clinician/Provider System (EMR/ EHR) Laboratory Information Management System CPHS Biosurveillance System County Public Health System CPHS receives EMR Alert Message Receive H1N1 message via alert or query Patient presents with potential symptoms Clinician Suspects H1N1 Infection Yes No Clinician orders H1N1 test Yes Treats patient and makes data entry EMR Entry Yes H1N1 Test Processed H1N1 test result Positive test result / H1N1 diagnosis Positive H1N1 diagnosis No Yes No Clinician Alerted EMR populates H1N1 message with available data End EMR sends H1N1 alert message Clinician / Provider provides details 14 Yes Contacts clinician/ provider for confirmation and details H1N1 Disease Surveillance MED INF 405 – Team Paper System Requirements The functional requirements, listed by system actor, are intended the functions required by each actor in order to develop an H1N1 biosurveillance system for CPHS. The goal is to transmit essential ambulatory care and emergency department visit, utilization, and lab result data from electronically enabled health care delivery and public health systems in standardized and anonymized format to authorized public health agencies within 24 hours. Laboratory Information Management System (LIMS) requirements: 1) The system uses HL7 2) The system electronically tracks patient’s laboratory orders 3) The system electronically receives laboratory orders 4) The system generates laboratory results 5) The system electronically transmits laboratory results to EHR and CPHS 6) The system electronically sends alerts when results generated to EHR and CPHS 7) The system must support HITSP/C35, HITSP/C36 and HITSP/C37 message formats 8) The system generates lab reports 9) The lab reports can be exported into any format 10) The lab reports can be transmitted electronically Clinical Information System (EHR/EMR) requirements: 1) CIS electronically places lab orders 2) CIS electronically receives lab results 3) CIS electronically receives lab alerts 4) CIS displays lab alerts to providers 5) CIS displays abnormal lab alerts in red to provider 6) CIS electronically tracks lab results by patient 7) CIS generates lab reports by patient to providers 8) CIS generates lab reports by patient/diagnosis/lab result to providers 9) CIS electronically receives instructions from CPHS to activate certain procedures that include laboratory testing. 10) CIS electronically receives health alerts regarding a detected public‘s health threat event. 11) CIS supports electronic reporting of individual patient data to CPHS, using HITSP/C39 message format. 12) CIS informs provider clinical decision-support by receiving the following information from the CHPS bio-surveillance system: Aggregated data on the health status of the community Notifications on a suspicious event Instructions to activate certain procedures related to the detection of the public‘s health threat event as determined by the public health response protocols CPHS Biosurveillance System requirements: 1) The bio-surveillance system electronically receives individual patient data from clinical settings (ambulatory settings and hospital emergency departments) EHRs. This includes data on symptoms, diagnosis, medication prescriptions, etc. 15 H1N1 Disease Surveillance MED INF 405 – Team Paper 2) The bio-surveillance system supports event detection algorithms 3) The bio-surveillance system analyzes individual patient data across providers to establish pattern of suspected public’s health threat event as needed. 4) The bio-surveillance system provides electronic access for providers to the daily community health status assessments 5) The bio-surveillance system electronically notifies providers regarding the suspected pattern as needed. 6) The bio-surveillance system electronically send instructions to providers to activate specific procedures to help determine the nature of the suspected pattern, e.g., order specific lab tests, ask certain questions during the exam. 7) The bio-surveillance system electronically receives additional data (daily) related to the activated specific procedures, e.g., laboratory data, data from questionnaires administered by providers, etc. 8) The bio-surveillance system electronically sends health alerts to providers regarding the detected event. 9) The bio-surveillance system electronically communicates with higher public health authorities (state, federal) regarding the suspicious pattern and detected event as determined by the public health response protocols. 10) The bio-surveillance system electronically sends health alerts to responders and to the authorities of neighboring jurisdictions regarding the detected event as determined by the public health response protocols. Standards The HITSP Biosurveillance Interoperability Specification, IS 02, focuses on a set of constrained standards for implementation of near real-time, public health event monitoring to support early detection, situational awareness and rapid response management across care delivery, public health and other authorized Government agencies. It prescribes the process or interaction that each primary stakeholder will invoke to capture, discover, anonymize and transmit relevant data.vii The CPHS bio-surveillance database will be propagated with H1N1 alerts from the following systems: Laboratory Information Management System (LIMS) Clinical Information System (CIS) - Hospital Electronic Health Record (EHR) Clinical Information System (CIS) - Electronic Medical Record (EMR) CPHS Bio-Surveillance System Web Portal – NEDSS- Use of standards and specifications by systems actor The CPHS bio-surveillance system will be the “central” system that will be responsible for collecting alerts from the outlying community providers and notifying the necessary community stakeholders. All of the system actors will send messages from their respective messaging systems utilizing a combination of the following standards and specifications (see the diagram below for clarification what standard each provider is using): 16 H1N1 Disease Surveillance MED INF 405 – Team Paper H1N1 Data Standards LIMS HL7, LOINC, UCUM, HITSP/C35, HITSP/C36, HITSP/C37 H , L7 D IC 9 H D, ME O N ,S CPHS biosurveillance database P /C ITS 39 HL 7, IC D9 , HTTP SN OM ED , HI TS P /C Hospital EHR Provider Web-based NEDSS entry portal 39 Provider EMR LIMS will communicate with the CPHS database using: o HL7 CDA R2 o IHE (LAB TF-3) o Logical Observation Identifiers Names and Codes (LOINC) o Unified Code for Units of Measure (UCUM) o HITSP/C35, HITSP/C36, HITSP/C37 Hospital EMR will communicate with the CPHS database using: o HL7 o ICD9 o SNOMED o HITSP/C39 Clinic/Provider EMR will communicate with the CPHS database using: o HL7 o ICD9 o SNOMED o HITSP/C39 Web-based Bio-Surveillance Portal will communicate with the CPHS database using: o HTTP o HTTPS The above standards are necessary to provider interoperability with the CPHS H1N1 biosurveillance alert system. They are used to realize direct information exchange, to provide the transport mechanism, to specify the content and address security concerns.viii 17 H1N1 Disease Surveillance MED INF 405 – Team Paper Description of standards and specificationsix HL7 CDA R2 – The HL7 Clinical Document Architecture is an Extensible Markup Language (XML)based document markup standard that specifies the structure and semantics of clinical documents for the purpose of exchange. CDA is one instantiation of HL7's Version 3.0 Reference Information Model (RIM) into a specific message format. Of particular focus for HITSP Interoperability Specifications are message formats for Laboratory Results and Continuity of Care (CCD) documents. Release 2 of the HL7 Clinical Document Architecture (CDA) is an extension to the original CDA document markup standard that specifies the structure and semantics of clinical documents for the purpose of exchange. CDA R2 includes a prose document in HTML, XML schemas, data dictionary, and sample CDA documents. CDA R2 further builds upon other HL7 standards beyond just the Version 3.0 Reference Information Model (RIM) and incorporates Version 3.0 Data Structures, Vocabulary, and the XML Implementation Technology Specifications for Data Types and Structures. For more information visit www.hl7.orgx HL7 Version 2.5.1 – Messaging Standard is an application protocol for electronic data exchange in healthcare. It and prior versions have widespread use in the U.S. and internationally. Both message formats and value sets / code tables (e.g., diagnosis type, gender, patient class, result status, specimen collection method, abnormal flags, observation result status codes interpretation, and timestamp format) are contained in the standard. IHE (LAB TF-3) - The IHE Laboratory Technical Framework introduces a content Integration Profile Sharing Laboratory Reports (LAB TF-3) that describes a clinical laboratory report as a human-readable electronic document. This document, which may also contain data in a machine-readable format, contains the complete set of final results produced by a clinical laboratory in fulfillment of one or more test orders for a patient. This document is focused on the sharing of sets of laboratory results in the form of a laboratory report structured document, and is not intended to address ordering or return of laboratory results to the ordering provider. For more information visit www.ihe.netxi SNOMED CT - consists of a technical design, core content architecture and Core content. SNOMED CT Core content includes the technical specification of SNOMED CT and fully integrated multi-specialty clinical content. The Core content also includes a concepts table, description table, relationships table, history table, ICD-9-CM mapping and Technical Reference Guide. ICD-9-CM The International Classification of Diseases, Ninth Revision, Clinical Modification (ICD9-CM) is based on the World Health Organization's Ninth Revision, International Classification of Diseases (ICD-9). ICD-9-CM is the official system of assigning codes to diagnoses and procedures associated with hospital utilization in the United States.xii LOINC - A database of universal identifiers for laboratory and other clinical observations. The laboratory portion of the LOINC database contains the usual categories of chemistry, hematology, serology, microbiology (including parasitology and virology) and toxicology; as well as categories for drugs and the cell counts typically reported on a complete blood count or a 18 H1N1 Disease Surveillance MED INF 405 – Team Paper cerebrospinal fluid cell count. Antibiotic susceptibilities are a separate category. The clinical portion of the LOINC database includes entries for vital signs, hemodynamics, intake/output, EKG, obstetric ultrasound, cardiac echo, urologic imaging, gastroendoscopic procedures, pulmonary ventilator management, selected survey instruments and other clinical observations. UCUM - A code system intended to include all units of measures being contemporarily used in international science, engineering, and business. The purpose is to facilitate unambiguous electronic communication of quantities together with their units. The focus is on electronic communication, as opposed to communication between humans. HITSP/C35 - The terminologies in this component apply equally to both the HITSP/C36 Lab Result Message and the HITSP/C37 Lab Report Document. The HITSP Technical Committee is constructing a mapping between these two representations to make the correspondence between data elements explicit. This mapping will be presented to the Health Level Seven (HL7) committees that publish the two representations with the expectation that HL7 will maintain the mapping.xiii HITSP/C36 is a lab result message that is dependent on HITSP/C35-Lab Result Terminology, HL7 version 2.5.1 and HITSP/C154 HITSP Data Dictionary. The purpose for HITSP/C35 is to supply the required vocabulary guidance information to be applied within the message exchange. HL7 version 2.5.1 defines the data structure requirement, and HITSP/C154 identified HITSP Data Elements (DE) that map to the HL7 DE constrained by this component.xiv HITSP/C37 is a lab report document that is dependent on the Integrating the Healthcare Enterprise (IHE) Laboratory Technical Framework Volume 3 (LAB TF-3) Document-based Transactions, Revision 2.0 – For Trial Implementation, August 16, 2007. The reason for this dependency is that it is a composite standard. HITSPC/C37 is also dependent on HITSP/C35 Lab Result Terminology as it supplies the required vocabulary guidance information to be applied within the exchange document.xv HITSP/C39 is patient encounter message for sending an encounter-based biosurveillance message. The trigger for sending encounter-based bio-surveillance data is the updating of patient-based data at the data source. In many instances the updating of data at the data source will generate a local HL7 transaction. Hypertext Transfer Protocol (HTTP) is an application-level protocol for distributed, collaborative, hypermedia information systems. The World Wide Web Consortium and the Internet Engineering Task Force (IETF), which defines HTTP/1.1 (the most commonly used version), have coordinated the standards development of HTTP.xvi Hypertext Transfer Protocol Secure (HTTPS) is a combination of the Hypertext Transfer Protocol with the SSL/TLS protocol to provide encryption and secure identification of the server. HTTPS connections are often used for payment transactions on the World Wide Web and for sensitive transactions in corporate information systems.xvii 19 H1N1 Disease Surveillance MED INF 405 – Team Paper Usage example of standard (HITSP/C37) Example of a HITSP/C37 Message from LIMS to CPHS xviii The functional flow scenario from our LIM system submission of laboratory bio-surveillance H1N1 test result to the CPHS bio-surveillance system is a necessary component of routine public health reporting processes which typically requires an established trusted communication channel prior to the actual transfer of bio-surveillance data being initiated. The pre-conditions assume a laboratory has processed an H1N1 sample and the test result is within the range and category of interest for bio-surveillance reporting as required by federal, state, or local health departments. The laboratory is also assumed to have a LIM system that can capture the information required to generate the report. The specific data elements (DE) managed by the laboratory LIM system are expected to be the source for information used in creating the bio-surveillance report. Detailed contents of the bio-surveillance report to support this use case are included in the HITSP/C37 Lab Report Document Component Specification. HITSP/C37 Lab Report Document Component Specificationxix HITSP/C37 component specification is to have laboratory and interpretation structured as Extensible Markup Language (XML) document for interchange to meet requirement for human and machine readability. The context also introduces properties of documents such as persistence, non-repudiation, and unique identification of documents. The component specification describes an electronic version of a laboratory report structured as an electronic document following the IHE LAB TF-3 and HL7 CDA R2 standards and specifications. Laboratory documents for exchange are described in this section. Pre-conditions to the process of exchanging a LIM system document are: The order and specimen must have been received by the laboratory, and the ordered test performed The electronic laboratory result has been deemed releasable by the sender The laboratory result conversion into CDA format has been accomplished The repository must be capable of preserving data required by the Clinical Laboratory Improvement Amendments (CLIA) that are subsequently sent in the CDA HITSP/C37 is dependent on IHE LAB TF-3 and HITSP/C35. HITSP/C35 supplies the required vocabulary guidance information to be applied within the exchange document. HITSP/C37 Data Structure A CDA document comprises a header and a body. IHE defines the header as: 20 H1N1 Disease Surveillance MED INF 405 – Team Paper Header identifies the patient, the clinical Laboratory that produced the report, the physician that ordered the tests, the encounter in which the act was performed, and other participants to this document (e.g. author, custodian, legal authenticator). The body comprises 2 levels. IHE defines the level 2 body as: The body is organized as a tree of up to 2 levels of sections, delivering humanreadable content of the report: Top-level sections represent laboratory specialties. A top level section may contain either a single text block carrying all the results produced for this specialty or a set of leaf sections. In addition, any leaf section SHALL contain a level 3 entry that contains the observations of that section in a machine-readable format. The Level 3 entry may be a multimedia entry or a machine processable entry. IHE defines them as follows: 21 Level 3 entries dedicated to multimedia rendering. A leaf section of the Laboratory Report MAY have optional entries to carry the multimedia objects mentioned in Level 2 narrative block, and provide their rendering. Multimedia rendering is based on the observation Media element in an entry dedicated to that purpose. And each leaf section of the Structured Body of a Laboratory Report MAY contain one entry containing the machine-readable result data rendered in the section. H1N1 Disease Surveillance MED INF 405 – Team Paper Information Architecture Clinician CPHS Official Clinician Terminal Clinician Terminal Web Browser HL7/XML | C35, C36, C37, C39 HTTPS Web-based NEDSS NEDSS Terminal Application Interface HTTPS CIS EAI HL7 LIMS EAI HL7 CIS LIMS Enterprise Application Integration (EAI) HL7 HTTP/ S C35 C36 C37 C154 CPHS BioSurveillance Database Database Tools Report Data Mine System Functions CPHS Biosurveillance System 22 Query H1N1 Disease Surveillance MED INF 405 – Team Paper Data Sets The data sets that will be used are based on the recommended data elements as found in the CDC’s Swine Influenza case report form dated April 30th, 2009. All specific codes and vocabularies will be in accordance with Center for Disease Control’s document titled: “Swine Flu (H1N1) Case Report Form – Standardized Vocabulary.”xx These data sets are listed below: 1) 2) 3) 4) 5) 6) Demographics Clinical Data (Signs, Symptoms) Medical History (Immunization, Disease) Diagnostic Findings (Lab Test, Lab Results) Treatment Epidemiology Data Element Constraints Data elements have limits placed on them and the values that may correspond within it. These limitations are called constraints. For example, a data element bearing the administrative “gender” could be limited to the concepts of “Male”, or “Female”. Furthermore, these restrictions can be concrete as well, such as a specific value set that must be used within the data element. For example, the administrative gender could be limited to the HL7 defined value set indentified using the 2.16.840.1.113883.1.11.1 OID (object identifier).xxi Listing the constraints related to all the data elements in the “Swine Flu (H1N1) Case Report Form” would be too far-reaching and hence, it is not part of this paper. Definition of individual data elements The individual data sets that make up the data elements are defined as follows: Demographics 1) 2) 3) 4) Date of Birth Race Ethnicity Sex Clinical Data (Signs, Symptoms) 1) 2) 3) 4) 5) 6) 23 Date of symptom onset Signs and Symptoms Was the patient hospitalized? Was the patient admitted to the intensive care unit? Did the patient require mechanical ventilation? Did the patient die as a result of this illness? H1N1 Disease Surveillance MED INF 405 – Team Paper Medical History 1) Did the case-patient receive influenza vaccine between September 2008 and March 2009? If yes: a. Number of doses b. Type of vaccine 2) Does the case-patient have any of the following? a. Asthma b. Other Chronic Lung disease c. Chronic heart or circulatory disease d. Metabolic disease (including diabetes mellitus) e. Kidney disease f. Cancer in the last 12 months g. Immunosuppressive condition (HIV infection, chronic corticosteroid therapy, or organ transplant recipient) h. Other chronic diseases i. Neurological disease Diagnostic Findings 1) 2) 3) 4) Leukopenia (yes or no) Lyphopenia (yes or no) Thrombocytopenia (yes or no) Did the patient have any of the following tests? a. Chest X-ray, If yes: i. Normal ii. Abnormal b. Chest CT scan, If yes: i. Normal ii. Abnormal 5) Influenza testing a. Test 1 i. Date collected ii. State Lab specimen ID 1. Specimen Type 2. Test Type 3. Results 4. Influenza Type/Subtype b. Test 2 i. Date collected ii. State Lab specimen ID 1. Specimen Type 2. Test Type 3. Results 4. Influenza Type/Subtype 24 H1N1 Disease Surveillance MED INF 405 – Team Paper b. Specimens sent to CDC i. Indicate when and what type of specimens (including sera) were sent to CDC and specimen ID 1. Date 2. Specimen type 3. State Lab Specimen ID Treatment 1) Did the patient receive antiviral medications? If yes: a. Drug (list provided) b. Date initiated c. Date discontinued d. Dosage (if known) Epidemiology 1) The following questions concern the 7 days prior to illness onset: (answer: yes, no or unknown) a. Did the patient travel to Mexico? b. Did the patient have close contact (within 2 meter (6 feet)) with a person (e.g. caring for, speaking with, or touching) who is suspected, probable or confirmed swine influenza case? c. Did the patient handle samples (animal or human) suspected of containing influenza virus in a laboratory or other setting? d. Has the patient had family members or close contacts with pneumonia or influenza-like illness? 2) Household Transmission a. How many people live in the household (include patient in this number)? b. For each person in the household, besides the patient, record age, check applicable symptoms if present anytime from 7 days before to 7 days after the patient’s onset date, and record initial symptom onset date. c. Have any of the patient’s household members been tested for influenza? If yes: i. Person# ii. Test date iii. Test result Data set sources The following table lists the data sets, their constituent data elements, the system actor that will house the data and the collection scenario for each data set. Data Set 25 Data Element Source System(s) Collection Scenario H1N1 Disease Surveillance MED INF 405 – Team Paper Demographics Date of Birth Race Ethnicity Primary: CIS (Hospital, Provider) I. Obtained by provider during patient encounter and registration, stored in CIS by clinician Secondary: LIMS (Laboratory) II. Obtained at hospital registration, stored in CIS Sex Data Set Clinical Data Data Element Date symptom onset III. May be accessed by laboratory LIMS through CIS interface Source System(s) Collection Scenario CIS (Hospital, Provider) I. Entered into CIS by clinician/provider as a result of the patient encounter, or hospitalization. Signs and Symptoms (SNOMED Concept Codes) Was the patient hospitalized? Was the patient admitted to the intensive care unit? Did the patient require mechanical ventilation? Did the patient die as a result of this illness? Data Set Medical History Data Element Received Flu vaccine between 9/2008 and 3/2009? (If so, # of doses?, 26 Source System(s) CIS (Hospital, Provider) Collection Scenario I. Obtained by clinician/provider from the medical history interview during the patient encounter, stored in CIS II. Obtained at hospital registration, H1N1 Disease Surveillance MED INF 405 – Team Paper vaccine type?) Existing Conditions? stored in CIS by hospital admin staff, data automatically ported to CIS Asthma Other Chronic Lung disease Chronic heart or circulatory disease Metabolic disease (including diabetes mellitus) Kidney disease Cancer in the last 12 months Immunosuppressiv e condition (HIV infection, chronic cortico-steroid therapy, organ transplant recipient) Other chronic diseases Neurological disease Data Set Diagnostic Findings Data Element Leukopenia (Y/N) Lyphopenia (Y/N) Thrombocytopenia (Y/N) Tests Taken? 27 Source Collection Scenario System(s) CIS (Hospital, I. Provided by provider or hospitalProvider) based clinician during patient encounter as a result of the diagnostic testing and treatment decisions made by the clinician, stored in CIS by clinician or staff H1N1 Disease Surveillance MED INF 405 – Team Paper Chest X-Ray (norm, abnormal) Chest CT scan (norm, abnormal) Influenza testing? Date collected/ specimen ID Specimen type Test type Results Type/Subtype (specimens sent to CDC, when, what type, ID) Date Specimen State Lab ID Data Set Treatment I. Test orders are entered and stored in the LIMS system when ordered by clinician. Test orders are also stored in CIS if ordered through Secondary: CIS (Hospital, II. Test results are entered and stored Provider) into LIMS system III. Test results are transmitted to clinician when finalized and stored in the CIS Data Element Source Collection Scenario System(s) Antiviral CIS (Hospital, I. Provided by provider or hospital-based Medication? Provider) clinician during patient encounter as a result of the diagnostic testing and Drug – from list treatment decisions made by the provided clinician, stored in CIS by clinician or Date initiated staff Date discontinued Dosage Data Set Data Element Epidemiology Questions re: 7 days prior to onset (Y, N, U): Mexico travel? Close contact? Handle samples? Family/close contacts w/ flulike illness? 28 Primary: LIMS (Laboratory) Source Collection Scenario System(s) CIS (Hospital, I. Obtained by clinician/provider from Provider) medical history interview during the patient encounter, stored in CIS H1N1 Disease Surveillance MED INF 405 – Team Paper Household transmission Number of inhabitants? Inhabitants w/ flu symptoms? Inhabitants tested for flu (number tested, date tested, test result)? 29 H1N1 Disease Surveillance MED INF 405 – Team Paper Data flow diagram H1N1 Confirmation Call Updated H1N1 Case Information email H1N1 Notification and Clinician Request for Details H1N1Lab Test Order NEDSS Via Lab’s Data entry Web Interface H1N1 Lab Test Order Clinical Data Entry H1N1 Diagnosis Web-based NEDSS Data H1N1 Diagnosis HITSP/C39 Internet Access H1N1 Lab Test Order H1N1 Lab Test Result Clinical Information System (EHR/EMR) H1N1 Lab Test Order H1N1 Lab Test Result LIMS EAI Engine CIS EAI Engine Web-based NEDSS Entry Form for CPHS Biosurveillance System Updated H1N1 Case Information H1N1 Confirmation Call Web-based NEDSS data CPHS EAI Engine H1N1 Test Order Alert HITSP Alert Messages H1N1 Lab Test Result CPHS Biosurveillance System Positive H1N1 Test Alert NEDSS Web Alert Updated H1N1 Case Data CPHS Public Health Officials H1N1 Lab Test Order H1N1 Test Order Alert HITSP/C35 Laboratory Information System (LIMS) Positive H1N1 Test Alert HITSP/C36, HITSP/C37 email H1N1 Notification and Request for Details CPHS Biosurveillance System Data Flows H1N1 Disease Surveillance MED INF 405 – Team Paper Endnotes i http://www.who.int/countries/eth/areas/surveillance/en/index.html President’s Council of Advisors on Science and Technology. U.S. Preparations for 2009-H1N1 Influenza. August 7, 2009. Available at: http://www.whitehouse.gov/assets/documents/PCAST_H1N1_Report .pdf iii Accessed October 23, 2009 from: http://www.medicalnewstoday.com/printerfriendlynews.pphp?newsid=167025 iv http://www.hsph.harvard.edu/news/press-releases/2009-releases/businesses-problems-maintianing-operationssignificant-h1n1-flu-outbreak.html v http://www.cdc.gov/nedss/Archive/Supporing_Public_Health_Surv.pdf vi http://www.bt.cdc.gov/DocumentsApp/HAN/han.asp vii http://www.hitsp.org/ConstructSet_Details.aspx?&PrefixAlpha=1&PrefixNumeric=02 viii HITSP/C35 Specification.<http://wiki.hitsp.org/docs/IS12/IS12-1.html> ix HITSP/C35 Specification.<http://wiki.hitsp.org/docs/IS12/IS12-1.html> x http://wiki.hitsp.org/docs/C37/C37-3.html xi http://wiki.hitsp.org/docs/C37/C37-3.html xii http://www.cdc.gov/nchs/icd/icd9cm.htm xiii HITSP/C35 Specification.<http://wiki.hitsp.org/docs/IS12/IS12-1.html> xiv HITSP/C36 Specification. <http://wiki.hitsp.org/docs/IS107/IS107-1.html> xv HITSP/C37 Specification. <http://wiki.hitsp.org/docs/IS77/IS77-1.html> xvi http://en.wikipedia.org/wiki/Hypertext_Transfer_Protocol xvii http://en.wikipedia.org/wiki/HTTP_Secure xviii HITSP Biosurveillance Interoperability Specification Version 3.2. <http://wiki.hitsp.org/docs/IS02/IS02-1.html> xix http://wiki.hitsp.org/docs/C37/C37-3.html xx Swine Flu (H1N1) Case Report Form – Standardized Vocabulary , <http://www.cdc.gov/phin/activities/standards/documents/Swine%20Flu_H1N1%20Case%20Report%20%20Std_Vocabulary%20(2).pdf> xxi http://wiki.hitsp.org/docs/TN903/TN903-5.html ii