ADVERSE EVENTS:
| Testifying Date | Testifier Name (*= EHR WG member/alternate) |
Points Made By Testifier | Comments |
| 02-Feb-07 | Rachel E. Behrman, MD MPH Director, Office of Critical Path Programs OC, FDA | • Classifies AE as adverse experience and adverse reaction • Covers foods, devices, and biological products (drugs, blood, blood products) • Adverse experience defined by level of acuity - if life threatening or unexpected they hear about quickly; not serious or expected then hear periodically. important for breakpoint is pre-market or post-market(different kinds of data), post market reporting - no denominator data, voluntary but med errors come in this way too but are different from drug specific adverse reactions/events • Vaccines - VAERS - required to report - more robust interest in reporting – Manufacturers must report serious serious events, Healthcare professionals must report contraindications to subsequent doses • Med device reporting is similar to drugs and biologics but more focused on user facility, reporting is required from manufacturer and user facility, voluntary from public thru MedWatch 3500 • primarily paper based system still in 2007 -paper is extremely limited - sit on largest repository of paper information but trying to go electronic • Modifying FDA website to create single protal for AE submission, Partnering with NIH to create rational questionnaire - ICSR - release 2 draft - balloted again at HL7 enable interoperability to get information and analyze it, will save $ as expensive to process paper reports, - have gateway for bulk reporting but no easy way for MD reporting in MedWatch - creates ICRS message • Interagency collaboration to standardize terminology used in HIT initiatives. - standardized collections UNII codes (many codes of Dilantin), or structured product labeling (SPL) on DailyMed - gets pushed daily to NLM (gets info out to public), VA: NDF-RT for pharmacological class • limitations on current system - too much paper and is expensive, passive surveillance, no demominator data • interest in active robust surveillance system connected electronically, but there is a need to address privacy and technology concerns • Path forward - standardized electronic format so we can automate our processes, expand data available, active surveillance of unbiased and complete health records, novel techniques such as data mining look promising. Effectively analyze information in a timely manner, provide current info for optimal safe, effective outcome. • Work with broader healthcare community to make sure we are collaborating but reaching full potential of info use options available |
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| Amy Patterson, MD, Office of Biotechnology Activities, Director, Clinical Research Policy Analysis and Coordination Program | • NIH operates in pre market/clinical research setting • Importance of AE in clinical research setting is for safety and well being of subject, but can also call for changes to doses, informed consent, etc. and adds to the generalized knowledge of that drug, • Issues – Divergent federal reporting requirements (Threshold, Scope, Timeframe) – Divergence creates confusion, non-compliance, increased costs – Poor quality of information (No standards, Incomplete reports) – Deluge of AERs that cannot be interpreted in multi-site trials – Negative effect on protection of human subjects • Federal Adverse Event Task Force Charge : Propose specific means for promoting harmonized and streamlined federal requirements for reporting, analyzing, and communicating adverse events in clinical research Member Agencies: NIH (chair), VA, DoD, FDA, OHRP, CDC, AHRQ Objectives: • Agencies will speak the same language (Reduce variability in terms and definitions, Alignment of federal AE reporting policies) • Develop best practices blueprint for reporting, analysis, and application of safety information • One core AE report that PIs can sent to multiple agencies (Basal Adverse Event Report (BAER)) • Basal Adverse Event Report (BAER) Scope • Fundamental set of medical information adopted by all agencies • Span pre- and post market • Used by PI and practitioner • Incorporation of HHS standards for data transmission and vocabularies Aims • Offer utility for reporting at local and federal level • Offer standards for full spectrum of clinical research Key Features • Utilizes existing data standards for AE reporting • Encompasses all forms of clinical research • Draws upon a single streamlined data set to report • Optimizes analysis and application of safety data Coordination with other initiatives • CDISC, HL7 (BRIDG), AHRQ, caAERS/caBIG Moving Forward Propose candidate terms and definitions for harmonization of federal reporting policies • Further engage stakeholders • Research community consultation • Formal clearance by HHS |
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| Blake Caldwell, MD, Strategy and Innovation Officer (Acting), Coordinating Center for Infectious Disease | • Takes seriously that the purpose of reporting is for response and action • Approach – combine facility-level clinical performance with national-level PH Surveillance and Response • Good surveillance program requires science basis • Standards – opportunity is to increase the use of existing data in hospital information systems by having common standards • Two systems to be reviewed: VAERS, NHSN • Work in collaboration with other agencies • NHSN – 3 components – Patient Safety, Personnel Safety, R&D. Healthcare associated infections, over 30 years, antimicrobial resistance tracking, 470 hospitals enrolled, looking for ways to enhanced and expansion, collected voluntary by infection control personnel, • States with public reporting of health care associated infections - California, Colorado, Connecticut, Florida, Illinois, Maryland, Missouri, New Hampshire, New York, Pennsylvania, South Carolina, Tennessee, Vermont, Virginia • Because of mandatory reporting NHSN expects over 1000 hospitals in 07, entered manually in hospitals in the web • Collaborations – Surgical Care Improvement – CMS; Patient Safety Monitoring Systems – CMS, FDA, AHRQ; Prevention of MRSA – VA; ADE – FDA; Tissue, transplant, blood safety – FDA, HRSA; IT Standards – CMS, FDA, AHRQ • Opportunity to use hospital data if we had standards, esurv pathway being piloted in 2 hosp, • CMS harmonizing SKIP and NHSN so facilities with both can directly link measures in both systems, • VAERS and VSD passive reporting to detect early warning signals and generate hypotheses in changes in AE, o Has limitations – underreporting, can’t assess causality, can’t approx. relative risk of AE, Reporter bias o Strengths - critical part of ability to assure vaccine safety because of its national scope and centralized data collection, working with FDA and piloted with EPIC to query a physician of possible adverse events and populate VAERS report • VSD system to test hypothesis - 8 HMOs using various data sources, data remains at the HMO but is queried by CDC • Lessons learned – each state is unique; achieving balance between transparency and protection of private info is a challenge; Data Standards are critical; Scientific basis important; need good surveillance systems to understand problems; direct resources and evaluate interventions; collaboration needed to succeed; surveillance is for intervention and response. |
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| Dixie Henry, AAG, Legal Counsel, Vermont Department of Health | • VT – Patient Safety Program (PSP) • Early stages of implementing a patient safety program • State legislation in 2006 requires mandatory reporting of intentional unsafe acts • Around June 30, 2007 - Effective in 2 stages o Mandatory reporting of “Never Events” o Mandatory hospital policies and procedures for other adverse events and near misses • Focus to foster a culture of safety in all hospitals in VT, • Focus on improving the system by identifying what went wrong in the system and then correcting it. • Reported to PSP – “Never Events” an Intentional Unsafe Acts (based on VA system) • Hospital internal reports – AEs, Near Misses, Causal analyses and corrective action plans • Hospital role is to detect AEs, State role is ensure that hospital is detecting and reporting the AEs. • PSP may allow electronic filing of “Never” and Intentional Unsafe Acts to be reported • Hospitals may use electronic systems to mine and detect AEs • Barriers – confidentiality due to small sample size in Vt • Within 2 years anticipate including some AE data in hospital community reports |
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| John R. Clarke, M.D, Clinical Director for the Pennsylvania Patient Safety Reporting System | • ECRI – non-profit health services research agency, an AHRQ evidence-based practice center. o Mission is to improve the safety, quality and cost-effectiveness of healthcare. o Focus - healthcare technology, healthcare risk and quality management, improve patient safety and envir. mgmt in hospital • PA reports serious event (AE), incidents (near misses) and infrastructure failures in all acute care facilities • PA Patient Safety Authority - independent agency established under state law to reduce harm from medical errors by identifying problems and implementing solutions that promote patient safety. Receives dedicated funding stream from annual assessment of facilities. • Acute Care facilities – “Adverse Events “ and “near Miss” reporting is required • Written patient notification, must be disclosure of the AE to the patient • Patient or providers are not identified in the AE report • Type of AE reported - “Serious Events”- events that result in patient harm, Incident = Near Miss, Infrastructure Failure • Outside entity – collect, evaluate, analyze; develop recommendations for improvement; educate facilities of changes they can make. Law requires that agency contract with outside organization. • Uses single web-based electronic reporting system. Reports entered by Patient Safety Offoce per Mcare Act 13 defn. and facilities patient safety plan. Can be interfaced with facility’s incident reports or risk mgmt systems. Generates reports for mandated reporting such as to the FDA. • Taxonomy – Medication Error, AE Reaction, Equip/Supplies/Devices, Fall, Error related to treatment, Complication from Treatment, Transfusion, Skin Integrity, Other/Misc • Realities – numerators likely incomplete (all reporting is voluntary), Few denominators, little epidemiology. Ability to detect signal above noise is qualitative. Types more important than numbers. Narratives are critical. • Much of the info is in narrative form – will need to use natural language processing or Bayesian classification to classify and prioritize reports, link to lessons learned. • All info not in EHRs – Team/Organization info. for example. • Link diagnosis, comorbidities and process/procedure info from EHR to process error, corrective action that’s not in EHR, how do you capture this team and org related info? • What is the error in the process? What are the contributing factors from the patient, from the system? What is root cause? Likely solutionsfor improvement? Outcomes of applying solution? |
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| Roland Gamache, Ph.D., MBA, Director, State Health Data Center, Indiana State Department of Health | • IOM report – for inpatient hospital care for preventable ADEs the annual cost is $3.5 billion. • Best approach to improve is by a review of healthcare system at all levels • Healthcare is decade or more behind other industries in attending to basic safety • In 2005 Proclamation from governor that required a medical error reporting system • Implementation began Jan 06, hospitals must report to IN DOH, web based system for reporting 27 conditions, patient and clinician identity not included, information given back to administrators at hospital to help improve prevention strategies • Not to be used for punishment • HIE may not be able to detect true error – but can pick up on signals and possible conditions in community – ex – Syphilis in hospital servicing a community – once identified was able to reduce in 3 mo. • Improvements oftent o process – ex – one hospital mark leg to be amputated with X, another hospital mark leg to be kept with X, same doctor works at both. • Look at clinical messaging data to help identify medical errors. |
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| Ed Helton, PhD., CDISC Board of Directors Chair-Elect, HL7 RCRIM Co-Chair, Chief Scientist Regulatory and Clinical Affairs SAS Institute Landen Bain, CDISC Liaison to Healthcare, Program Manager HIMSS New Directions Life Sciences Project and Demonstratio |
• The CDISC road map is designed to harmonize these standards to the BRIDG (Biomedical Research Integrated Domain Group) model – shows data models are being implemented and interact and will provide an opportunity to collect, analyze and submit data • Highest priority is semantic interoperability (CDISC, FDA, HL7, NCI) • Data flow - models in there but EHR at the top and HL7 for the ability to start moving that data - working closely with FDA • BRIDG terminology links all standards but doesn't show link back to HL7 • Will move data in seamless way in HL7 V3 messages or Operational Data Model (ODM) XML Schema • Vendor neutral • 3 Standards currently being harmonized within the BRIDG to Support Safety Surveillance – Adverse Event Reporting o CDISC Study Data Tabulation Model (SDTM) – AE during clinical trials o ICH E2B = Individual Case Safety Report (ICSR) – post marketing AE on approved products. o Federal AE Task Force Basal Adverse Event Report (BAER) – for reporting to Institutional Review Boards and other Safety Surveillance • CDISC/IHE/HIMSS – work together on Retrieve Form for Data Capture (RFD). • Allows EHR to host guest forms from external agencies such as clinical research and drug safety orgs using standards from CDISC, HL7, WWWC and EMEA • Retrieve Form for Data Capture (RFD) - develop integration profile to enable EHR to become single point of data capture, not only for patient care but also all secondary uses - breakdowns the work into different actors and enables conversation between EHR and external agencies o RFD enables automatic re-use of data already in the EHR, and allows for external parties to collect additional data during an EHR session. |
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| Ron Valdiserri, MD, MPH, Chief Consultant, Public Health Strategic Health Care Group | • VA involved in – Medical Care, Graduate medical education, Research, Emergency Preparedness • Largest integrated healthcare system in US • Use Vista / CPRS (Computerized Patient Record System) serves over 5 million veterans. • HAISS Program (Hospital Acquired and Syndromic Surveillance) - VA received $ in 06 to develop a nationwide system to monitor healthcare associated infections - needs assessment conducted across system in 04 identified want for ability to do data mining - want to spend less time reviewing charts and more time acting on information from data • In Feb 07, VA will make award to work on 4 features – 1. allow to collect data electronically, working closely with NHSN - currently 16 VHA hospitals, will want to grow to cover all 300 hospitals 2. Syndromic surveillance for preparedness - ability to detect illnesses and syndromes, 3. Detect organism of EPI significance - antimicrobial resistance, clustering, etc. 4. Antibiotic use and decision support, monitor trends in antimicrobial resistance • Surveillance is information for public health action |
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| Nancy Foster, Vice President, Quality and Patient Safety | • Many demands on hospitals today • Many data collections that are similar but slightly different • We have homework to do before common reporting is possible - what do we need, how do we need it and how do we move forward? • Need to have all stakeholders to have this discussion • Need definitions • Also figure out how to get information that is needed but will never be part of the health records • No bright line between quality and population health issues • Clear identification of common data elements and definitions to be used for all purposes • Common mission --- What are we trying to accomplish? • Who are the users of the information? • What do they need to know? • What data elements are needed? • How can they be derived from or standardized with data collected for other purposes? • Many objectives - Device safety, Medication safety (clinical), Medication safety (manufacturer), Track clinical research events, Quality improvement, Medical errors, Infection tracking • Who are the users? Provider organizations/ clinicians, Consumers, Manufacturers, Accrediting and oversight organizations, Regulators of providers, clinicians, manufacturers • Can data be collected in a standardized way? Data elements vs narratives/ |
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| Marc Overhage, MD, PhD, FACP, FACMI, Director Regenstreif Institute, Inc. | • Access to data must be negotiated and then managed • Adverse drug events in the ambulatory setting - Indiana network for patient care - way we find events doesn't work well today - auto screening for adverse events using data from labs, Rx, symptoms, diagnosis, notes, etc. - • Need to detect errors to prevent them. This takes resources and funding. o One study – only 3 of 54 ADEs identified by study were reported (6%) o 2 of 26 serious ADEs had an incident report • Use clinical triggers to screen for AEs – example Naloxone use; Serum Digoxin > 2.0 ng/ml; receiving nephrotoxin and creatinine has risen • Pragmatic approach – Develop critieria; Implement criteria wih clinical query languages e.g. CARE at Regenstreif; Identify triggers for 4 mo; Review ADEs identified (pharmacist, clinican reiver – 2 levels, severity Venyulet’s descriptors o Example - Cough on ACE inhibitor; adjust criteria based on sensitivity/specificity. • Signals only indicate that an ADE may have occurred and still needs verification o Trigger categories – generic, surrogate, combination • Process – Batch query -> potential ADEs -> ADE -> ADE Database • 75% ADEs represented by 1/3 of the signals • Preliminary outcomes show significant reduction in ADEs – but cannot be cited yet!!! • Outpatient ADE Detection – Goals – Determine frequency and types, compare search methods, determine severity of ADEs. o 4 strategies used – ICD-9s, Allergy, Computer event monitoring, Data mining. o ADE rate 5.5 per 100 patients coming for care (identified 25,056 – ADE actual 864) |
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| Michael Ibara, Pharm.D., Head of Pharmacovigilance Information Management | • Pharmacovigilance and the EHR • Improve Public Safety is the key objective • Technology is the enabler • Currently exploting how HER and digital healthcare impact pharmacovigilance – still exploratory. 4 areas o RHIOS o Aggregated EHRs o CDISC RFD project o NHIN • All share a common set of issues and problems, operating environment is global, understand current environment o Regional health organizations contains many of stakeholders in healthcare, definition of safety varies greatly depending on stakeholder perspective. Have done executive on loan to help them understand pharmaceutical perspective as they face their own challenges o Aggregated EHR data, looking at how this data could be useful to pharmacovigulance, what value does this data have for safety? How do you define what data is needed? What is missing that may have an impact? o CDISC RFD (Retrieve Form for Data) – profile that allows a clinical data form to be surfaced from within and EHR transparently to user. Pharmacovigulance use case – EHR recognizes and pre-populates patient info for physicians to approve and send to MAH and regulators. o NHIN write use case for reporting of safety events that shares common goals with biosurveillance. ‘Slipstream’ work with Accenture Consortium. Include pharmaceutical perspective in NHIN. Safety concerns are global – care is local. • Opportunities exist at the interface between clinical practice and clinical research/regulatory reporting. Great impact is possible, standards are key, theory should give way to modeling the practical problems of collecting data from EHRs. • Great potential for Biosurveillance and Pharmacovigilance to address common issues • Direction – Apply true informatics approach, deliberate approach o Better understand domain – standards, experimentation, concepts and Roles, terminology and definitions o Factors to thinking about pharmacovigilance – adoption of standards for exchange of info, maturing technology, progress on EHRs and PHRs, public interest. • Wealth of information can create a poverty of attention!!! • Medical judgment is required in safety – goal is to provide decision support – not replace judgment. • Data are created – not just waiting to be gathered, collected or recorded. • Improving patient safety is global – most effective HIT applications should be designed for global use |
OUTBREAK:
| Testifying Date | Testifier Name (*= EHR WG member/alternate) |
Points Made By Testifier |
| 29-Mar-07 | Paula Soper, MPH, Senior Analyst for Public Health Informatics, NACCHO | § Domain areas: Environmental; Foodborne; Communicable; Natural Disaster; Chem or Rad. Locals organized differently and not all LHDs are responsible for all of these. § Discussed the role of local health departments (LHDs). The following are things they focus in on: o Detect o Identify o Investigate o Manage o Contain § Needs differ by event type. Mumps outbreak multi-state, difficult to get vaccine data. Couldn’t determine if it was vaccine failure or failure to get kids kids vaccinated. § Import to have demographics data (food outbreak-FDA) § There are no challenges in getting data. Legally they have the right but there is a perception issue regarding HIPPA with providers. (Doctors not 100% aware of PHs legal authority and right to access data) § Almost everything today is from chart extraction. § Need further investment in local PH infrastructure. Most electronic systems are MS Access or EPI-Info – not standards-based § HIT data exchange will elevate errors and help decrease redundancy, enhance communications capabilities. § But never eliminate paper and pencil data gathering i.e. asking patients for their info/interviewing/filling out forms § Only 9% of LHD have implemented federal health IT standards, 29% use EHRs –why the discrepancy?? |
| Dr Marci Layton, Assistant Commissioner, New York City Department of Health and Dr Annie Fine, Medical Director, New York City Department of Health | Information Needs in Outbreak Management: A Local Perspective West Nile Outbreak: Huge media event therefore there was huge demand for data on a daily basis Anthrax 2001: § West Nile Outbreak: New disease, regional, cross-jurisdictions. Tracking lab data was a challenge. Challenge to link epi-data, unique ID concept not employed, Huge media event therefore there was huge demand for data on a daily basis § Anthrax 2001: Relatively small outbreak More than 3000 white powder events although most were false. Very challenging to keep track of all this. Involved non-traditional partners like postal service. No automated system available that could manage all the data – samples form worksites, nasal swabs, white powder samples from many sources. Relationship and contact tracing were complex and difficult to support. § SARS: New unexpected disease, Communicable with a high fatality rate, isolation and quarantine was needed, contact tracing requirement complex. In Toronto, lack of robust info systems was impediment to outbreak control. § Steps – Detection and verification; active case finding, triage and investigation; Lab testing; contact tracing and mgmt; Environmental investigation; Epi analysis; Intervention, communications, control measures § Complex outbreaks o Pressure for daily summary reports, o Most require being on site therefore paper pencil method of gathering data o Complex analysis-need of maps, time and people location, o Need to manage work-interviews, tracking down missing data, case-follow-up o Dynamic data needs o Need to track patient outcomes o Support workflow management § Characteristics of an Ideal Outbreak Management System o Easy to navigate o Suitable for simple outbreaks but scalable for complex ones o System needs to be able to interact with paper pencil system b/c that is what is currently being used o Scalable from routine outbreaks to complex ones o Data entry screens easily formatted o Ability to generate unique ids o Support questionnaires definition, printing and versioning o Support standard vocabularies o Must be secure, support remote access, employ redundancy, support user-defined roles and access o Support data analysis or exporting to analysis tools § Currently using: o Word o Excel not complex enough o CDC Outbreak Management System o Web based survey tools i.e. MrInterview, SurveyMonkey § Some of the options that could be used in the future: o CDC Outbreak Management System – if development resumes o Access w/SQL o Customized system o Commercial system § Conclusions o Clinical data insufficient for outbreak management o Need federal support for improved outbreak management tools such as OMS o State and loca HDs must have strong roles in evaluating tools o Strengthen IT infrastructure at state and local levels |
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| Janet Hamilton, MPH, Surveillance Section Administrator, Florida Department of Health | § Application centered approach to demonstrate data needs. § Merlin – web-based surveillance and reporting system used by all 67 Florida county departments § Florida has used the ICS structure since Hurricanes of 2004. § Merlin Outbreak Module is a tool for documenting and analyzing outbreaks and unusual disease occurrences. Used at state level to look across jurisdictions. Helps counties to pull stats about outbreaks quickly § The state wants to provide good hands on training to local departments. § Disease reporting via Merlin: Medical facilities/labs send info to county health dept then sent to Florida State Health Department (Merlin) then to CDC. § Merlin is easy to navigate, enter in info easily, multiple simultaneous users with different roles, gives ability to manage and report data in different ways (information the media really wants). Allows more time for actual detection and investigation. § Merlin was evaluated against PHIN Early Event Detection standards – these proved very helpful in determining enhancements to the application. |
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| Dr. Marion Kainer, Director, Hospital Infections and Antimicrobial Resistance Program | § Complexity of capturing exposure data during contact investigations for communicable diseases. § Communicable diseases – SARS, H5N1 influenza, Measles, TB; some are vaccine preventable, others are not. All require contact tracing. § Contact TB Investigation example described o Had to track complex follow-up on all cases and their contacts o One case alone had over 200 contacts o Needed to track relationships and exposures o Relationships may be between many entity types: people, animals, objects, orgs, events, travel events, conveyances and locations § There was a need to capture all data information and Excel spreadsheet would not be sufficient. § CDC’s Outbreak Management System was used to manage the TB outbreak. It is a powerful tool for managing outbreak investigations and tracking exposures and contacts o Flexible and configurable o Has core data and ability to extend system to capture outbreak specific data o Supports contact tracing between multiple entity types o Includes daily reports to drive investigation § Conclusions o OMS powerful tool for managing contact investigations o Improves Epi response in conjunction with SAS, MS Access, social networking software and GIS o Sustainable tool for managing multiple or large contact investigations § CSTE Assessment conducted a survey in Feb 2007 on need for an Outbreak Management Tool. o States and locals reported it was very important to have a system such as CDC’s OMS o Most jurisdictions not prepared for data management of large complex outbreak o Many were planning to use CDC’s OMS 1.2 o Want OMS to exchange messages with lab and surveillance systems o Want it deployed as web-based and client-server § CSTE Recommendations o Reinstate federal support for CDC’s OMS 1.2 o Reconvene working group o Prioritize high value enhancements such as messaging § Gaps/Next Steps for AHIC o Advocate for additional federal investment in tools for outbreak data management such as CDC’s OMS o Data-needs for management of exposures in healthcare settings – capture and easily access info on patient/staff movements |
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| Tim Morris, Director of the Division of Informatics Shared Services, Centers for Disease Control and Prevention | § Public Health response needed for: Bioterrorism, Chemical, Radiation, Mass Casualty, Natural Disaster, Disease Outbreaks § Response partners include: CDC, FDA, USDA, FEMA, Local and State PH, Homeland Security, DHHS, law enforcement, clinical care, commercial vendors and contractors § Information types include: Cases, contacts, exposure cohorts; lab orders and results; interventions,; environmental data; spatial data; health alerts; recommendations § Interoperability – 2 types o Symantic – terminology, format, content o Physical – transport, security, directory services, identifiers § Speaker went through differences in data needs for Monkeypox, SARS, and Katrina o Monkeypox – multi-state zoonotic transmission, tracking animal manifests, multiple venues for animal-human exposure, had to deal with sources with international points of origin o SARs – emerging infectious disease with international implications, evolving case definition, no confirmatory lab testing, challenges linking epi and lab data, had to manage isolation and quarantine, contact tracing was cross-jurisdictional. o Katrina – infectious disease detection, prevention and outbreak control in shelters and affected communities, environmental and food safety issues, rebuilding infrastructure, distributed data collection and analysis § Current challenges – multiple entities involved, cross-jurisdictional data sharing, complexity of information, lack of integration, infrastructure needs to be strengthened, need resources and training § Work to do – flexible and secure NHIN, consistent implementation of standards, common terminology usage and definitions, shared infrastructure for authentication and routing, systems available to support response |
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| 29-Mar-07 | Dr Norman Crouch, Assistant Commissioner, Health Protection Bureau, Minnesota Department of Health | § Public Health labs support multiple functions – outbreak detection and investigation, monitoring of trends, assuring quality, informing intervention, and supporting policy. § PH labs focus on populations, clinical labs focus on the individual. The two are interdependent and work together it identify public health threats. § Multiple lab networks exists o Lab Response Network o National Lab System o National Molecular Subtyping Network § Pyramid of labs support the structure with Sentinel on the bottom, then state PH labs, then CDC § Networks supported Anthrax incident and will support Pan Flu preparedness § Labs include – Clinical care, Local PH, Veterinary, Agriculture § Exchange partners are : Sentinel labs, CDC, Agency Epi Programs, Public Safety Officials, other State PH labs § Data needs: Sample/specimen accessioning; reporting analytical results to submitters and network; integrating lab data/epi case data; tracking sentinel lab capacity and capability § Barriers: IT changes rapidly; lack of PH lab standards; high systems development costs; limited input from state PH labs § Challenge of large commercial labs: Reporting standards need to be developed; reporting must be across states and they have specific reporting requirements; there’s no acceptable central place to send reports so they can be disseminated properly or made available for retrieval. |
| Dr Steve Hinrichs, Director, Center for D21; Director, Nebraska Public Health Laboratory | § Lab testing supports Early Warning and Surveillance o Suspected – request to test patient with symptoms o Incidental – tests reveal unusual result or select agent is detected § Planning for preparation and response to PH events has been done § Collaborative activities: LIMS user groups; Open Source LIMS development; harmonization of vocab standards § Short-term: secure web reporting and XML spread sheet transmittal (not technically optimal for long-term solution) § Long-term: automated multi-directional electronic transmission of clinically significant lab results for event response; electronic exchange of test results and test orders § Lab results can have national implications § During a surge, test load may need to be distributed across labs § PHLIP – Public Health Interoperability Project – community solution concept; solutions to submit unsolicited de-identified surveillance results; simultaneous reporting to state and CDC; Harmonize influenza data elements; prototype message structure for 6 PHL’s § PHLIP Outcomes: standard message structure applicable to all notifiable diseases; accommodate high level and granular description of lab tests and orders; collaborative resource portal for sharing outcomes. § Challenges: Data variability; cross border data exchange; technology – LIMS implementations; de-duplication of non-linked data; approach for disease monitoring; sustainable support; integration of large commercial labs; bi-directional data exchange among partners including federal partners § Recommendations: o Consider full breadth of lab functions and capabilities - animal, water, environmental testing o Evaluate how to achieve uniform reporting o Recommend process for sustained support of IT at state and local levels o Support national OID solution for lab service providers and medical service providers o Recommend implementing uniform minimum data elements within state law for reportable conditions o Support research on predictive trend analysis and statistical sampling for monitoring health of population |
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| Dr Mike Miller, Associate Director for Science, Centers for Disease Control and Prevention | § CCID lab capacity – 1000 labs, additional 43 within NCEH, surge capacity is robust § 80-85 CDC-Atl labs are registered as select agent § Lab Response activities: outbreak surveillance and response; reference identification capacity; PH research; pathogen discovery; vaccine discovery and AE tracking; organism repositories; preparedness and response; lab support § Partners: State PH agencies, World health agencies; other federal and state agencies; private sector; academia; medical community… § Examples of work have dealt with novel etiologic agents that are now fully characterized – Legionella, Hanta virus, SARs… § CDC role in PH and emergency response o National and international events o Assist in investigations when invited o Apply pathogen discovery tools o Temporal data analysis with redirection o International reference labs and repositories o Extensive specimen inventories and data banks § Surveillance tools for Foodborne Outbreaks: o FoodNet (Foodborne Diseases Active Surveillance Network) § Conducts population-based, active surveillance for laboratory-confirmed infections caused by 9 pathogens commonly transmitted through food § Campylobacter spp., Listeria monocytogenes, Salmonella spp., Shigella spp., STEC O157, Vibrio spp., Yersinia enterocolitica, Cryptosporidium spp., Cyclospora spp. o NARMS (National Antimicrobial Resistance Monitoring System) -Conducts integrated surveillance to monitor the development of antimicrobial drug resistance among enteric pathogens from humans (CDC), foods (FDA), and animals (USDA) o PulseNet USA -Standardized molecular typing of foodborne disease-causing bacteria by pulsed-field gel electrophoresis (PFGE) o OutbreakNet -Network of state and federal public health officials who investigate foodborne disease outbreaks; Epidemiologists, microbiologists, regulatory officials in 50 states; Long-standing collaboration formalized o NEDSS (National Electronic Diseases Surveillance System) - Effort to standardize and streamline surveillance for individual cases of nationally reportable diseases – Struggling, not yet successful o From eFORS to Outbreak Reporting System (ORS) -Will incorporate foodborne, waterborne and other enteric outbreak reporting (including norovirus) into one system – enhance user interface § Challenges: o FDA approval of PH assays within a timely manner – especially to support emergency response o Recruitment and retention of lab scientists– speaks to education challenges o Developing expertise in the next generation of PH leaders o Electronic communications needs o Integrating critical PH info and tracking in a secure, efficient and accessible format |
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| Emory Meeks, Enterprise Laboratory Systems Coordinator, Centers for Disease Control and Prevention | § Lab support of PH during response – Must be able to support bi-directional exchange of test orders and results; standards are imperative to support this § Anthrax – 125,000 samples = > 1,000,000 lab tests were needed – huge burden on labs. Much of the consolidation was manual. § Lab Response Network (LRN) – coordinated network of PH and other labs for which CDC provides standard assays and protocols for testing biological and chemical terrorism agents. § Strengthen preparedness by enabling 2-way std electronic data exchange: lab-lab, lab –partners § LRN Strategies – interim solution with CDC’s LRN Results Messenger; Long-term – integration and standardized solution with Lab’s own LIMS § LRN Results Messenger – Covers 94% of LRN; lab – CDC reporting; LRN Proficiency testing support; Rapid auto update capabilities; Routing to CDC’s BioSense and DHS’s Biological Warning and Incident Char. (BWIC) § LIMS integration parallel efforts – Collaborating with 9 labs; labs given integration requirements and constrained version of PHIN Lab Generic message guide, with mapping for LRN assays. § LRN Future Plans – handle exchange for LRN-Chemical; better integration with other PHIN applications and services; promote interoperability with other agencies via ICLN; allow setup of recipients § PHLIP – State, APHL, CDC collaborative project: focus on lab data exchange of NND results and orders; vocabulary harmonization; HL7 data exchange § Integrated Consortium of Laboratory Networks (ICLN): organized by Homland Security to promote harmonization and coordination across multiple lab networks affiliated with federal agencies § Data Exchange Needs: Refine and implement lab standards; harmonize requirements across agencies for reporting; labs need funding for informatics § Agency to Agency issues – Interagency data exchange needs to be accomplished; labs may have to report to multiple agencies differently; prioritization and funding are required to make this happen. |
RESPONSE MANAGEMENT:
| Testifying Date | Testifier Name (*= EHR WG member/alternate) |
Points Made By Testifier |
| Jun-07 | Joe Gibson, Director of Epidemiology, Health and Hospital Corporation of Marion County, IN Department of Health | o Outlined Response to Disease Incidents, Control measures, Information flows, local public health informatics projects, and vision of the future of public health informatics and RM. o Intensity of control depends on the magnitude of health risk, likelihood of control success, and resources available. Investigation typically takes more resources than control. o IN has 60 sets of intervention specs, corresponding to 60 disease categories o Local health officers have permission to do whatever they need to as long as it is reasonable and necessary. They have a significant amount of power. o The department tries to get as much personal information as possible in order to be able to track disease. (i.e. address, place of employment). o The department ensures that treatment is given and that it is completed. A specific example of this was with the TB cases but they have also done this with rabies cases. o Communication is done by telephone, fax, face -to -face, as well as advisory boards for mass populations. State uses HAN o City- County use WebEOC, PR coord. Phone, moving toward Natl. Incident Mgmt Sys. o Participate in the Robert Wood Johnson-funded “Common Ground” project - define common processes which include incident management, case management, communication, mass shelter facilities. communication, mass shelter facilities. o Clinical Volunteers registry – list of clinicians willing to help in state of emergency. o 2-county unified, real-time EMS data System -Population Health Data System o Challenged when tying in WIC and immunization registry due to data quality and dedupl. issues.. o Some concerns: prevention of data transfer due to security, privacy; not enough local input in systems, locals too busy fulfilling preparedness. reqs to satisfy intent., ill-fitting stds and systems cause locals to create work-arounds o Positive expectations: Encouragement of multiple systems in funding; drill down and rule out ability; modular systems with hooks for integration; improved case reporting and investigation tools incl. query and response, bi-dir exchange with clinical to populate case info.. o Automation on the control side could help ensure that treatments are being received and completed. |
| Jun-07 | Torney Smith, Spokane, WA Regional Health District | o Data flow originally occurs in hospital and then distributed through RAMSI(system). o The use of telephone and fax as the predominate use of communication with some electronic data exchange o Hospital system legal staff are concerned about public health access due to the Health Insurance Portability and Accountability Act ???? Prevented active surveillance using hospital system data. o Venders and clinicians need to work on standards of coding issues. o Future of public health could be more damaging than beneficial due to the following: 1) Various systems that are large and difficult to uncode. 2) Integration is yet to be achievable and this is crucial. o Some challenges include: 1) No financial benefit creates more work 2) Under funded for the past 10-12 years. Tools that are being developed need to have flexibility and have the ability to exchange data with one another. Spokane Regional Health has been under funded for so long that a tradeoff exists between funding technology advancement and simply providing ongoing services o The Spokane Regional Health System serves 10 counties in eastern Washington State. o Spokane’s hospital-based computerized system links more than 30 hospitals in those counties, Idaho, and Montana. o During a highly contagious outbreak of national importance, the system would notify hospital system clinicians using Ramses, the Inland Northwest Health Services’ e-mail system, and, predominately, phone and fax. o Predicted continued reliance on phone and fax also due to electronic data issues, such as completeness, timeliness, and coding errors. o To improve integrated RM, vendors and clinicians need to work on standards and coding issues. Unique patient identifiers across systems would be very useful. o Registries are often developed as needed but are not readily shareable. o The regional system has caches of limited countermeasure materials funded by the Metropolitan Medical Response System (MMRS) and the Health Resources and Services Administration (HRSA). o Countermeasure distribution systems are available for tracking and follow-up but are not well-integrated – a key issue across the various systems. o The regional system is involved in the Common Ground project. o Developing the business case for public health access to clinical data is important, as hospitals seem to be moving forward with electronic systems that do not account for public health needs. o There is a need for flexibility in IT tools that would help localities capture data for public health in a consistent manner. |
| Jun-07 | Tim Wiedrich, North Dakota Department of Health | o North Dakota is completing a registry of integrated data from various medical licensure boards primarily funded by emergency preparedness and response grants, as well as U.S. Department of Health and Human Services (HHS) hospital grants. o Data from licensure boards is converted to standardized format and imported into HAN. o Data dumps will have the capacity to mobilize 3,000 public health and hospital personnel through a simple callback protocol and potentially 17,000 medical professionals for staging in emergencies. System is activated during large scale emergencies. o Determine who should be alerted/solicited base on location, expertise, licensure o Statewide inventory control system – identify inventory levels, track transport status, report distribution. o Web-based hospital capacity system - hospitals can go online and input bed capacity. o In large emergencies telephones do not work. Dependency on telephone system is not adequate. o Instituted a statewide video conferencing capability through its Network system for information and objectives sharing, feedback, and discussion for routine matters and large-scale emergencies. o A statewide management information system for emergencies uses off-the-shelf software, WebEOC, that is integrated with the Network system. o Specialized software and command infrastructure modeled on the Strategic National Stockpile (SNS) can allocate, help move, and help track needed countermeasures nearly in real-time statewide. o System is untried and integration with other relevant State and Federal systems is lacking. Materiels’ bar codes are important to the system, but most of these bar codes do not include lot numbers. |
| Jun-07 | Aggie Leitheiser, Minnesota Department of Health | o Minnesota has 87 counties that are organized into 53 public health communities. o Currently they use the following for response management: Social distancing; codeReady- a personal and family preparedness campaign; isolation and quarantine; antiviral and antibiotics; vaccines, exchange of pertinent info o codeReady – all-hazard multi-disciplinary program to get ready on your own. o Isolation and Quarantine – identify and track ill people and contacts. Exchange info with PH, providers, public safety and emergency managers; other responders. o Personal protective equip – managing stockpiles, setting priorities, tracking billing, ventilators – currently doesn’t include chronic care and psychotropic meds. o Antivirals and antibiotics – inventory management, tracking from stockpile to provider to patient; monitor adverse events; goal of 48 hr response time o Vaccines are more difficult to track because people have to be treated individually. Adverse Events; immunizations registries modified to track countermeasures; booster doses and recalls. o Some challenges include: 1) standardization of bar codes across federal, state, private materials. 2) The needs of the public and their partners will be very difficult: o Hepatitis A outbreak occurred this past summer: There was a large volume of information that occurred from this ‘small’ event and there was a need to coordinate with the department’s partners. Some response management measures included a hotline that was requested, immunizations for the public that were conducted on state fair grounds, and media involvement. Shows gaps between the information exchange public health needs and its information capacity. o Some challenges include: 1) Systems driven by various funding streams – don’t interoperate 2) Limited input from state and local departments. 3) Rapidly changing technology, high cost in developing new systems and funding. o Recommendations include coordination, integration, and interoperability across partners and systems; clear and consistent guidance, standards, and shared expected outcomes, including between Federal and State partners; systems useful for daily work as well as for disasters; technical support and ongoing funding; and uniform minimum data elements for essential functions and interoperability standards for exchange with public and private partners. |
| Jun-07 | Tom Savel, National Center for Public Health Informatics, CDC | o There is a need for pharmaceuticals to be ready to be able to provide quantity of meds. o Managing and allocation of medications is necesary. o Capabilities are needed for single and mass events. o The need to know what counter measures are available and who has already received meds/care is necessary. o It is necessary for detailed personal tracking and aggregation of data. o Lessons Learned came from Small Pox and Influenza vaccination shortage in 2004/2005. Integration with other preparedness systems are necessary (IT infrastructure). o CDC is currently using SDO-Endorsed Standards. Where standards don’t exist the CDC is trying to create standards. o Information should be easily exchanged. o The need to leverage partnerships in public and private is a current challenge. o Information systems are critical to managing response and tracking countermeasures. o The two primary needs are for pharmaceutical and medical materials inventory data and information about who receives countermeasures. o Knowing quantities and locations of needed materials in the commercial market is critical. o Monitoring materials’ efficacy and identifying AEs are important but require challenging information exchanges. o Capabilities should include aggregate counts and detailed person-level tracking for any size event; integration with inventory, surveillance, and AE reporting systems; and post-event prophylaxis tracking. o In an outbreak, data requirements would include manufacturer, supplier, and distributor IDs and names; lot numbers and expiration dates; quantity and units of measure; shipping location information; organizational and staff information; patient demographics; administration information; and isolation and quarantine data. o One way that CDC and State and local public health are addressing critical, outstanding issues is through the Countermeasure and Response Administration (CRA) program. o CDC has identified some needed data exchange standards and is developing others with Standard Development Organizations. o For inventory tracking involving the commercial sector, CDC has recommended use of standard pharmaceutical electronic data interchange to facilitate industry participation. o CRA administration tracking interfaces with immunization registries. o Long-term plans may include augmenting immunization registries and developing interfaces with emergency responder and AE systems registries. o AHIC could help address the needs to incorporate countermeasure management functionality into electronic health record (EHR) systems, for pharmaceutical industry support of inventory tracking, and for funding to States for automating administration tracking and interoperability with registries as well as, potentially, with healthcare organizations. |
| Jun-07 | Gary Urquhart, National Center for Immunization and Respiratory Diseases, CDC | Immunization Information Systems (IIS): o Hurricane Katrina IIS was able to provide immunizations to many of the displaced children. Most children lost all immunization information but through IIS system they were able to recover records. This saved millions (4.6 million) in re-immunization. o After Hurricane Katrina, the Louisiana Immunization Network for Kids Statewide (LINKS) remained operational via a backup server and using HL7 messaging with another IIS, records were retrieved for 60,000 displaced children, o Use of mature IISs and the CRA to address vaccine efficacy and safety is expected to receive further consideration. Greg Burel, Acting Director, Division of Strategic National Stockpile, Coordinating Center for Terrorism Preparedness and Emergency Response, CDC, gave a slide presentation entitled “Overview of Strategic National Stockpile Information Systems”. o Natl Vaccine Advisory Committee (NVAC) recommends data to be name, birthdate, birth state/country, mother’s name, vaccine type, manuf.; vaccine date, vaccine lot number. Subset of this for Pan Flu o HL7 standard is a program requirement. Standards are used to improve interoperability. o AHIC recommendations: 1. Use IIS experience to leverage EHR development and implementation and in preparedness planning for public health emergencies. 2. Facilitate devl of natl administrative or legal approaches for routine inter-state immuniz. Data exchange. 3. Continue devl of EMR standards to enhance interoperability with IIS. 4. Ensure that priorities are established for immunization programs to address use of IIS for emergency preparedness activities. 5. Increase provider participation in an IIS – work with Natl Vaccine Program Office 6. Consider provider performance incentives based on completeness of immune. Data in IIS 7. Incorporate IIS reporting standards into EMRs for certification |
| Jun-07 | Greg Burel, Coordinating Center for Terrorism Preparedness and Emergency Response, CDC | o The mission is to deliver critical medical assets to the site of a national emergency. o Stockpile Resource Planning – Oracle system, COTS product, supports inventory and financial planning and tracking. Not accessible to states. o RSS Inventory Tracking System – free to project areas, helps states to manage SNS materiel, web-based, used by 34 project areas, in Phase II of rollout. 1) receipt, store, stage (RSS) site status 2) Point of Dispensing Site Status (POD) 3) Treatment Center Status Information Gaps in the Stockpile: o Info doesn’t come back from treatment center to POD sites. o Telephone system doesn’t work well in an emergency. o There is a need for obtaining as much information as possible. |
MCH:
| Testifying Date | Testifier Name (*= EHR WG member/alternate) |
Points Made By Testifier |
| Mar-08 | John Lumpkin | • Structure of MCH programs may vary from State to State, but the content is similar. Federal and State programs for women and children are clinically oriented but also non-clinically oriented, such as food and nutrition programs. • MCH covers: Pre-conception, Prenatal, Perinatal, Birth, Early childhood, Childhood, Adolescence • Many States have enhanced Medicaid eligibility for pregnant women, the U.S. Department of Agriculture’s Women, Infants, and Children (WIC) food program, and Healthy Start. • Infant and child programs include Early and Periodic Screening, Diagnosis, and Treatment (EPSDT) and well child care under Medicaid, WIC, immunization, early intervention, well water testing, metabolic screening and cases management, and blood lead testing. • IDPH Cornerstone – WIC, Family Case Management, program, Immunization, Pediatric Primary Care, Medicaid integration o Features - Common enrollment, Automated care planning w/Decision support, Scheduling and referral, Wide Area Network architecture • Birth related systems - Birth Certificate, SS# enumeration at birth program, Adverse Pregnancy Outcome System (Registry), WIC, Family Case Management, Medicaid enrollment, Metabolic Screening Program, Newborn generated well water testing program • MCH program integration is directly related to good outcomes. In IL, integration of clinical and other determinants such as WIC has demonstrably lowered infant mortality for women who participate. • System designed to meet needs of frontline workers also meets needs of program administration • Integration with EHRs and non-medical service delivery is essential |
| Cheryl Austein Casnoff, Associate Administrator, Office of Health Information Technology, HRSA | • HRSA’s safety net community (FY ’08 budget of about $7-billion )- focus on Health Centers where clients are mostly children, nearly 1 in every 15 Americans across the country—mostly minorities, many lacking insurance • Their Office of HIT’s - provides HIT information to HRSA grantees, bureaus, offices, and other stakeholders to promote improved quality and patient outcomes and reductions in health disparities through effective HI technologies adoption. • Provide planning and implementation grants for HIT innovations and provide technical assistance (TA) to HRSA grantees and staff. • Helping vendors understand the unique aspects of working with Health Centers. • With AHRQ - OHIT has also established an HIT Community portal for HRSA grantees. Serves as a virtual community for health centers, networks and PCAs to collaborate around the adoption of technologies promoting patient safety and higher quality of care. • Barriers to HIT adoption: o Huge undertaking that should not be underestimated. Anxiety is understandable. o Scarce funding, staffing, other resources. Competing priorities: patients and daily operations vs. HIT? o Challenging to select software, hardware, appropriate HIT tools, partners, vendors, etc. o Sorting through the flood of information on HIT. o Achieving real change – clinical practice, operations, staff responsibilities and duties. • Lessons learned: o Determine your goals and move forward deliberately. o Identify organization’s needs and determine how HIT adoption will address this need. Don’t adopt HIT for HIT’s sake. o Identify roles and responsibilities, expectations, goals, and resources such as technical assistance. o Leadership is crucial. Who is responsible for making sure that HIT transformation occurs? |
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| Jean D. Moody-Williams, RN, MPP, Director, Division of Quality, Evaluation and Health Outcomes Family and Children's Health Programs Group Center for Medicaid and State Operations Centers for Medicare and Medicaid Services | • Medicaid programs > 42 million low-income children, adults, disabled and elderly, Medicaid > 29 million children, SCHIP – nearly 7 million children • Federal and State Medicaid spending for medical services is estimated to exceed $347 billion in Fiscal Year (FY) 2009, $2 trillion over the next five years, and $5 trillion over the next 10 years • Total Medicaid spending on children will exceed $400 billion over the next five years and $1 trillion over ten years, which is approximately 20 percent of total spending over these time periods • Medicaid and SCHIP thus represent a major payor of health care in America and must be involved in the transformation of health information systems to improve quality and safety, create efficiencies and reduce disparities • The pillars of the Medicaid/SCHIP framework are: – Evidenced-Based Care and Quality Measurement – Supporting Value Based Payment methodologies – Health Information Technology – Partnerships – Information Dissemination and Technical Assistance – Health Care Disparities • The Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) service is Medicaid's comprehensive and preventive child health program for individuals under the age of 21 – consists of: (1) assuring the availability and accessibility of required health care resources; and (2) helping Medicaid recipients and their parents or guardians effectively use these resources • MITA - Seeks to re-orient Medicaid information systems towards a more beneficiary-centered approach - establishes a foundation that can support the integration of clinical and administrative data, support of program analysis and decision making and enhanced capacity for Medicaid to communicate with other programs and payers |
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| Clarence Smiley, MPH, MT(ASCP), Greg Shorr, MD, Amy Groom, MPH, Indian Health Service, Office of Information Technology | • Resource and Patient Management System (RPMS) - ~40 year old system, deployed at ~350 sites throughout the IHS, serving ~2,000,000 Native Americans. • A National Data Warehouse receives routine data exports using standard HL7 messaging. • “Womb to Tomb” patient record system supporting clinical care, population care, practice management, quality management, research, and Congressional reporting. • Primary objectives: • See the whole patient by summarizing and integrating information • See the whole patient population and community (or sub-population) to support population-based health care. • Traditional EHR Content: problem list, lab results, prescriptions, allergies, reminders, measurements Multiple tools exist to “roll up” data from local sites on a regional or national basis • Multiple examples of bidirectional sharing of data with Immunization Exchange and Reference Lab Interface • Obstetric Care Module to monitor First OB Visit, Follow up OB Visit, L&D / Consultant Visit, Post Partum • Well Child Module has dynamically determined guidelines, dynamically customized for each specific well child visit • Immunization Data Exchange Initiative to develop an electronic bi-directional immunization data exchange between RPMS and state Immunization Information Systems (IIS) • Initial exports from 6 IHS facilities to a state IIS (patients 0 – 18 years of age) – Sent 1,128,380 shots for 87,737 people – Of those, 920,602 shots, 37,932 people were NEW to the state IIS • What IHS got back – 490,449 NEW shots for their patients • Currently operational* in ~ 40 sites • Highlights of Dr. Shorr’s conclusion included: (1) that IHS now has the ability to build registries “on the fly,” such as through the ICARE module, and (2) that IHS is in the process of integrating prenatal records with the well child module. • Some sites are currently doing one way exchange only (to the state registry) |
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| Apr-08 | Christopher A. Kus, MD, MPH, Pediatric Director, Division of Family Health, NYS Department of Health | • Early childhood development • Women’s preventive health • Adolescent preventive health • Emotional behavioral health • Children with special health care needs • Health Equity Key issue - Long-term Follow-up (LTFU)- Assuring that ongoing, high-quality medical management are provided within the context of a medical home, assuring transition of young adults to appropriate adult medical care, assessing patient progress, collecting and analyzing state LTFU data, quality improvement • States are most actively engaged in the first component of LTFU – assuring high quality medical management and care coordination • The level of clinical tracking varies greatly for each disorder category • States have experimented with innovative approaches to LTFU, particularly when dedicated federal funding has been available Challenges - low priority accorded to LTFU compared to other newborn screening activities and an associated scarcity of resources. Next Steps - Secure funding, develop standards, povide resources and technical assistance to states as they develop LTFU activities |
| Marilyn Kacica, M.D.,M.P.H., Medical Director, Division of Family Health, New York State Department of Health | MCH Data Systems • Statewide Perinatal Data System Electronic Birth Certificate with QI variables • Neonatal Intensive Care Unit Module • Lead Registry • Family Planning Program Clinic Visit Record • Early Intervention • Newborn Blood Spot Screening • Newborn Hearing Screening (future) • Congenital Malformation Registry Integrated Child Health Information Systems – prototype ICHIS, Statewide secure network, simultaneous development of a number of child health information systems, • Looking to the future to link with expanding Electronic Health Records (EHR) systems / standards Benefits - Can we identify main health outcomes and possible link to potential risk factors? Are health outcomes of children improving? Can we assess quality and access to care and create a community level child health report card? Barriers o Separate legal authorization, funding, confidentiality rules o Insular program function and community o Isolated data, data definitions, vocabularies, access roles o Communication – Communication – Communication o Lack of standardization for data elements o Sustained resources including personnel o Focusing data collection on program activities o Different access rules for different data o Varying consent and confidentiality provisions o Other statutory and regulatory restrictions • Implications of planning for integrated CHI systems - integrated environment within DOH that fosters the creation of application and infrastructure standards following federal and state guidelines, formalized project management approach , good communication. Need to ensure Bi-directional informational flow, leverage existing infrastructure, use a phased approach, use middleware for mapping/translation to have flexibility • Scalable and extensible to other key NYS projects of interest: Regional Health Information Exchange (aka RHIOs), Electronic Health Record (EHR) |
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| Michael Flynt | NYSIIS - the New York State Immunization Information System - A confidential, web-based data system, collect and consolidate vaccination information from health care providers located in New York State, outside of New York City. (New York City has their own registry - mandatory since 1997). o Voluntary participation by providers since 1994 in regional registries – Healthy Shot and IRIS. Consent to participate was required. o Legislatively mandated provider participation as of January 1, 2008 for immunizations given to children less than 19 years of age (including immunization history). No opt-out provision. o Lifespan system (with consent, once aged 19 years or older). • EDS awarded contract in 2006 to modify Wisconsin Immunization Registry (WIR) for NYS needs. Read/write access for health care providers and their designees and Read only access for other authorized users (i.e. schools) • Features: Deduplication algorithm, Recommendation “scheduler”, Patient level immunization history report, AAP Health Appraisal form, Reminder and recall notifications, Vaccine inventory, VFC reports, Assessment, benchmark and ad hoc reports (AFIX). • Data export files accepted from vendors/providers using electronic billing or EMR systems. Standard HL-7 or flat file specifications. • Vital records birth certificate information, including immunizations administered at birth, “seed” the NYSIIS database. (Pre-loading all births in NYS outside of NYC since 1994). Weekly updates planned along with NYC exchange • As of March 31, 2008: 664,852 patients, 7,906,651 immunizations, 749 active organizations • Potential Data Linkages to: Lead Screening, Newborn Hearing Screening, Newborn Bloodspot Screening, BMI/Obesity, Public Health Emergency Preparedness, SNS inventory management, Countermeasure and response administration, Health Plans, Medicaid, Medicare, WIC, Indian Health Services, Congenital Malformations • National Picture - Immunization information systems are operational in 46 states. • Healthy People 2010 goal (objective 14.26) is 95% of children from birth through age five with two or more shots in a fully functioning immunization information system. • Opportunities – clarify benefit to effort, reduce backlog, increase stds adoption, v Expand legal authority to exchange information with other programs/jurisdictions (FERPA, cross border, etc.). v Develop universal parameters for matching/ deduplicating records during integration with various data systems. |
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| Michele A. Lloyd-Puryear, M.D., Ph.D., Chief, Genetic Services Branch, Division of Services for Children with Special Health Needs, Maternal and Child Health Bureau | • Newborn Screening and Health Systems Infrastructure Program – approx. 4 million infants are born yearly in the US & are screened to detect conditions that threaten their life & long-term health. • Screening, Diagnosis, Follow-up, Management and Eval - may prevent a child’s death, serious illness, or disability. 1) Traditional biochemical screening for inherited conditions (metabolic, endocrine, hematological, etc.)Screening for congenital hearing loss • Develop a unified record on every child to capture accurate information in a timely manner, support decision-making at the point of service, support program needs • Integrating information systems – access complete & accurate information and improve health • Activities and Products: – Title V supported Special Projects of Regional & National Significance (SPRANS) (1999-2006) • Maternal and Child Health Bureau • Planning Grants to 22 States FY 99, 00, 01 • Implementation Grants to 16 States in FY 02 and 03 – Cooperative Agreement with Public Health Informatics Institute – Regional Newborn Screening and Genetic Services Collaboratives—long term follow-up and tracking projects in 3 regions (2004-2011) – NNSGRC national data system on State and Territorial NBS activities • Connections - Funded by the HRSA/MCHB Genetic Services Branch June ’02-May’10 – 18 state and local public health – “Groups of people who share a concern, a set of problems or a passion about a topic and who deepen their knowledge and expertise in this area by interacting on an ongoing basis.” • Lessons Learned – Data are for sharing – assets to share among programs – Communication is critical – with all stakeholders – Change is hard – change management strategies to mitigate this challenge increase the likelihood of success – Public health and clinical needs must drive technology – project goals, objectives & functionality must be identified prior to searching for technology solutions – Stay the course – adoption of new technology is slow, perseverance & patience should pay off |
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| Amy Metroka, MSW, Director, Citywide Immunization Registry, and Angel Aponte, Computer Specialist, CIR, Bureau of Immunization, NYC Department of Health and Mental Hygiene | • Immunization information systems - are confidential, computerized information systems that record, store, and provide access to children’s immunization records • Benefits • Consolidates immunization records across providers • Provides access to immunization histories and recommendations - reduces missed opportunities • Identifies children in need of immunizations and facilitates reminder/recall to parents • Monitors vaccine uptake and coverage - targets resources to areas of greatest need • Helps control outbreaks - identifies people at risk • Increases staff productivity - saves money • Helps schools ensure compliance • Contribute to HIENs - leveraging existing data sharing, existing population-based data, technical expertise: de-duplication, database management, Web applications, data exchange including HL7, existing relationships with many relevant stakeholders, and governance exerience • NYC IIS - Operational since 1997; accessible via Internet (Online Registry) in 2002, 3.3 million records with over 33 million immunizations • Mandatory reporting of all immunizations administered to individuals < 19 years • Vital records loaded weekly (file includes birth certificates, corrections, infant deaths) • Cater Child Index - In 1999, decision made to integrate CIR and Lead Quest (LQ), the blood lead test registry • Completed Master Child Index (MCI) in 2004 – Contains all patients in CIR and LQ – Enables display of immunizations and lead test results in Online Registry – Able to display other child health information (e.g., newborn screening results) • Data reported - Vital records: ~128,000 births • Immunizing providers: – Batch file transfer: 3.1 million (51%) immunizations – Online Registry: 1.5 million (25%) immunizations – Paper: 1.4 million (24%) immunizations • New Jersey (NJ) IIS: ~ 4,000 immunizations • Laboratories: ~ 500,000 lead tests • 2007 Data Shared • 420,000 (25%) immunization records sent out via batch file transfer • 375,000 (23%) lead records sent out via batch file transfer • 27,000 (2%) immunization and lead records made available via phone/fax/mail • 840,000 (50%) immunization and lead records viewed through the Online Registry • Online Registry live on Internet in June 2002, for external use by providers, health plans, schools. Providers report immunizations (and lead results by June 2008) in real-time, Providers, health plans, schools access immunization and lead screening histories - offers providers clinical decision support, auto-filled medical forms (day care, schools, camp) • Dramatic increase in use in the last 2 years • Improves lead coverage - – % of children with > 1 blood lead level test before 3rd birthday increased from 84% in 2003 to 89% in 2006 • Immunization coverage improvement: – % of children 19 - 35 months of age completing the 4:3:1:3:3:1 vaccine series increased from 72% in 2006 to 80% in 2007 (National Immunization Survey) – % of children 10 - 12 months of age completing the 3:2:2:2:3 vaccine series increased from 33% in 2006 to 53% in 2007 (CIR) – % of children with a NJ address completing the 4:3:1:3:3:1 vaccine series increased from 25% to 32% (CIR) • 2008 Bi-directional Data Exchange - Build HL7 Web services to exchange data between CIR and: – Provider Electronic Health Records (EHRs) • Real-time reporting (eliminate duplicate data entry) • Provide CIR’s consolidated immunization history and decision support back to EHRs – Other IISs, e.g., New York State, NJ – Regional Health Information Organizations • HL7 Web Services- CIR Implementation- finish May ’08, test with EHR vendors (May - June 2008) • Change EHR to use Web services and display integrated immunization history and decision support and deploy integrated EHR • Challenges • Difficult, until recently, to identify partners ready to use HL7 • Partners accustomed to batch file data exchange – Real-time required for decision support • Partners need to integrate, store, and display their information and CIR’s in their own application in a user-friendly way • Design Challenges • HL7 standard is complex, difficult to learn to read/write messages, testing requires use of new tools • Technical design very time-consuming, requirements gathering and technical design is complicated (many ways to solve some problems) • IIS functions not 100% covered by HL7 messages – Different HL7 versions • 2.3.1 (NYC), 2.4 (NYS), 2.5 (Some EHRs) • Commercial parser helps – Variations from standard HL7 messages • VFC eligibility by shot • Use of custom HL7 message components called ‘z’ segments – Use of different code sets (CVX, CPT) • Lessons Learned – Budget a lot of time: it’s worth the investment • Complex process, logistics of getting 2 or more parties to agree on design – Helpful to have a standard for everyone to code to (HL7) – Development of a thorough HL7 Web services integration guide (available) has been very useful to partners • Conclusion IIS infrastructure can be successfully leveraged: • As a platform for integration of child health information systems within public health (MCI) • As a portal to child health records for health care providers, health plans, schools (Online Registry) • For real-time, bi-directional sharing of child health information with provider EHRs, HIENs (Web services) |
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| Chris Wells, PhDc, MS, Director, Public Health Informatics Unit Colorado Department of Public Health & Environment Health, Colorado Department of Health | • CSHCN – Children with Special Health Care Needs • CSHCN Data Integration System (IDS) has two components: • CHIRP – Clinical Health Information Records of Patients • NEST – Needs, Evaluation, Screening and Tracking History • EHDI (Early Hearing Detection and Intervention) grant (October 2000) • Original 5 year cooperative agreement with CDC • 3 additional EHDI RFPs (2006-2008) • CHIRP and NEST applications fully integrated November 2006 • CHIRP - Program/Agency specific, customized to track program/agency caseload, includes standard/Customized reports • CHIRP Applications: Newborn Hearing Screening, Health Care Program for Children with Special Needs (HCP), State HCP staff, Traumatic Brain Injury (TBI), Newborn Metabolic Screening, Hemoglobinopathy Screening, Sickle Cell Screening, Inherited Metabolic Disease (IMD) Screening, IMD staff at The Children’s Hospital (TCH) • NEST • Centralized database • Assigns unique identifier to each individual • Allows CHIRP applications to communicate • Shares data based on business rules • Built using Microsoft BizTalk Server • NEST incorporates data from: CDPHE Vital Records Electronic Birth Certificate (EBC). Used by the NBH follow-up coordinator to identify newborn hearing cases, as well as those newborns who missed the screening • NEST incorporates data from: State Laboratory and Research Department Newborn Metabolic Screening Results • NEST incorporates data from: Colorado Responds to Children with Special Needs (CRCSN)—CO birth defects registry • Advantages • Eliminates illegibility and reduces error • Facilitates data collection and analysis for quality improvement • Reduces redundancy by eliminating double entry • Automates and improves communications • Automatic generation of letters • Barriers • Lack of standardization for data elements • Sustained resources including personnel • Different access rules for different data • Varying consent and confidentiality provisions • Other statutory and regulatory restrictions • Resistance to change • Communication barriers between interested parties |
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| Marcus Cheatham, PhD, Assistant Deputy Health Officer, Ingham County Health Department | • Core principles: • Integrated systems should focus on populations most in need. • Integrated systems should connect systems of care that serve those most in need. • Integrated systems should connect clients with the entire universe of resources available to them in one stop. • Conflicted Terrain: On the one hand, MCH systems continue to try to integrate by “tunneling” into one another in discrete development projects. An example is the effort to integrate newborn screening and birth certificates which is not standards-based. On the other, the State is attempting to launch RHIO based HIE. Some MCH systems are becoming standards-based so they can integrate with HIEs • Michigan Care Improvement Registry: Started as simple childhood immunization registry. Becoming HL7 compliant. Expects to interoperate with EMRs and clinical messaging systems through RHIOs in the future. • Identified as platform for integration with lead test, asthma registry, sickle cell, newborn screening. Serious work underway. However current plans are mostly for flags, not integrated data. • Michigan WIC Data: is looking to integration. Focus of the work was on the ability to use EBT cards in order to improve the efficiency of WIC workflow (which is important) rather than data integration. • Michigan Vital Records: Birth certificates the single most important source of MCH data. Manually linked with CSHC, birth defects, newborn screening, for analysis. Used for research not care. • Little impact on public health practice: With exception of nurse with privileges, MIHP Nurses report never using electronic systems to obtain referrals or data on clients. • Efforts at MCH integration should identify RHIO based HIE as a promising means of obtaining and integrating data. • PHRs, EMRs and clinical messaging systems can feed MCH systems. • RHIOs and HIEs can be queried to fill missing data in MCH systems. • MCH integration should drive HIE into public health and FQHC settings in order to ensure that the most at risk fully participate. |
REFERENCE RESOURCES:
| Meeting Date | Distribution / Reference Resources Distributed & Discussed |
| Feb-06 | Adoption Tool Kits: A summary/ listing of tool kit and HIT adoption assistance from AAFP, ACP, eHI. |
| Mar-06 | CDC/ NCHS NAMCA survey “Computerized Clinical Support Systems in Medical Settings: United States,2001–03” Catharine W.Burt,Ed.D.,andEstherHing,M.P.H.,DivisionofHealthCareStatistics |
| Mar-06 | PITAC June 2004 http://www.nitrd.gov/pitac |
| Mar-06 | Healthcare Financial Management Association Feb 2006 “Overcoming Barriers to Electronic Health Record Adoption” Results of Survey and Roundtable Discussions Conducted by the Healthcare Financial Management Association visit www.hfma.org/EHR |
| Top Barriers: 59% Lack of sufficient funding; 43% Lack of available staff resources 28% Lack of financial return | |
| -HFMA’s survey showed the following expectations for government related to funding and creating financial incentives for EHR adoption: | |
| Provide grant funding (45 percent extreme; 35 percent high) | |
| Provide payment incentives (38 percent extreme; 32 percent high) | |
| Simplify Medicare payment system (37 percent extreme; 26 percent high) | |
| Accelerate investment in regional networks (26 percent extreme; 37 percent high) | |
| Mar-06 | Audet, AM (et al) “INFORMATION TECHNOLOGIES: WHEN WILL THEY MAKE IT INTO PHYSICIANS’ BLACK BAGS?” Medscape General Medicine Dec. 7, 2004 Full text is available at: http://www.medscape.com/viewarticle/493210 |
| Mar-06 | The January 19, 2005, Health Affairs Article (Walker, J., et. al.) “The Value of Health Care Information Exchange and Interoperability”, refers to this as Level 3 Interoperability: Machine-organizable data—transmission of structured messages containing non-standardized data. Level 3 interface development costs based on expert opinion- $50,000 per interface for labs and $20,000 per interface in group practice offices |
| Oct-06 | Baron, R J. et al "Electronic Health Records: Just around the Corner? Or over the Cliff? Annals of Internal Medicine. Philidelphia: Aug 2, 2005. Vol. 143 Iss. 3; pg. 222, 5 pgs. |
| Oct-06 | Middleton, B. et.al. "Accelerating U.S. EHR Adoption: How to Get There From Here. Recommendation Base on the 2004 ACMI Retreat. Journal American Medical Informatics Association 2005; 12:13-19. |
| Oct-06 | Poon, E.G. "Overcoming Barriers to Adopting And Implementing Computerized Physician Order Entry Systems in U.S. Hospitals" July/August 2004 Health Affairs. |
| Oct-06 | Miller, RH & Sim, I. "Physicians' Use of Electronic Medical Records: Barriers And Solutions" Health Affairs, March/April 2004 pg 116-126 |
| Oct-06 | Middleton, B. "Achieving U.S. Health Information Technology Adoption: The Need For a Third Hand" Health Affairs Volume 24 Number 5 Sept/Oct 2005 |
| Oct-06 | Johnson, D et. al. "Patient Safety in the Physician's Office: Assessing the Value of Ambulatory CPOE. CHCF: CITL 2004 |
| Oct-06 | "Assessing the Economics of EMR Adoption and Successful Implementation in Physician Small practice Settings" Executive Summary Sept 30, 2006 |