Nikolay Lipskiy, MD, DrPH, MBA 1, Anna Orlova, PhD 2 and Roniqua Watkins, BS 1 1OSELS/PHITPO/DIPPC, CDC, Atlanta, GA, 2OD, Public Health Data Standards Consortium (PHDSC), Baltimore, MD Public Health Laboratory (PH-Lab) Electronic Public Health Laboratory (PH-Lab) Electronic Data Exchange : Business Processes and Interoperability Solutions Data Exchange : Business Processes and Interoperability Solutions Public Health Laboratory (PH-Lab) Electronic Data Exchange : Business Processes and Interoperability Solutions

ACKNOWLEDGMENTS  CDC Office of Surveillance, Epidemiology and Laboratory Services  ONC Standards and Interoperability (S&I) Framework, Laboratory Reporting Interface (LRI) Public Health Laboratory reporting Sub-group  PHIN Vocabulary and Messaging Community of Practice (VM CoP) and PHIN Technical Assistance Team  Public Health Data Standards Consortium (PHDSC)  Association of Public Health Laboratories (APHL)  American Health Information Management Association (AHIMA)  Scientific technology Corporation  Atlas Public Health  IBM Research

Background  The electronic submission of reportable lab results to public health is one of the Electronic Health Record (EHR) Meaningful Use (MU) objectives  Harmonization of health IT (HIT) standards for Public Health Laboratory (PH-Lab) results reporting between clinical care and population health aims to improve emergency response and case reporting  CDC’s Office of Surveillance, Epidemiology and Laboratory Services (OSELS) and PHIN facilitate harmonization of the PH-Lab Reporting across public health  The Public Health Laboratory Report Sub-group of the ONC S&I LRI activity and PHDSC engage partners on assessing existing gaps in the PH-Lab standardization and aligning MU objectives with broader public health needs

Presentation Outline  Preliminary results of the CDC OSELS/PHDSC/APHL/AHIMA project for operationalizing HIT standards PH-Lab data exchanges  White Paper/Roadmap for PH-Lab Interoperability  Building PH-Lab Interoperability  HL7 Public Health Reporting Requirements Standard  IHE Integration Profile: Public Health Reporting- PH-Lab  HL7 Public Health Functional Profile - PH-Lab  PH-Lab and National Health IT Standardization Initiatives

Presentation Outline  Preliminary results of the CDC OSELS/PHDSC/APHL/AHIMA project for operationalizing HIT standards PH-Lab data exchanges  White Paper/Roadmap for PH-Lab Interoperability  Building PH-Lab Interoperability  HL7 Public Health Reporting Requirements Standard  IHE Integration Profile: Public Health Reporting- PH-Lab  HL7 Public Health Functional Profile - PH-Lab  PH-Lab and National Health IT Standardization Initiatives

White Paper on PH-Lab Interoperability  Efforts to Date:  PH-Lab Collaborative Business Requirements Project (APHL and Public Health Informatics Institute (PHII))  APHL PH-Lab Interoperability Project (PHLIP)  CDC PH-Lab Interoperability Solutions and Solution Architecture (PHLISSA)  CDC Meaningful Use Electronic Laboratory Reporting Initiative  Reportable Conditions Mapping Tables (RMCT) Initiative  HL PH-Lab Reporting Implementation Guide  ONC S&I Electronic Laboratory Interchange Implementation Guide  IHE Laboratory Reporting Integration Profiles for Document-based (CDA) Laboratory Reports  Laboratory Interoperability Collaborative (Surescripts, College of American Pathologists (CAP))  Ontoreason OPHPR/Lab Ontology Model Project

White Paper on PH-Lab Interoperability  Assessment of Content Data Sources (Examples)

White Paper on PH-Lab Interoperability  Assessment of Process Flows for Lab Preparedness

White Paper on PH-Lab Interoperability  Harmonization of Data Standards – RCMT – Mapping reportable Conditions to LOINC and SNOMED Standards

White Paper on PH-Lab Interoperability  Actors: A Public Health Laboratory can have up to 10 different recipients of similar or identical information such as 1. Other public health laboratories 2. Commercial laboratories 3. Primary care providers 4. Hospital infectious control practitioners 5. Health program directors 6. State public health departments 7. State chief medical/health officer 8. City or county chief medical/health officers 9. State epidemiologists, and 10. Federal agencies Source: APHL PHLIP Project

White Paper on PH-Lab Interoperability  Review of Use Cases: Source: APHL PHLIP Project

White Paper on PH-Lab Interoperability  Interoperability is required for two PH Lab business processes  Receive Test Order  Send Test Result  Selected PH-Lab Data Exchange Scenarios:  Antrax  Tularemia  Hepatitus B (hep B)  Tuberculosis (TB)  Influenza

White Paper on PH-Lab Interoperability  Methodology to Operationalize PH-Lab Standards:

PHDSC PH-Lab Project by HIT Standardization Phases, Products and Entities HIT Standardization Phases Needs & Priorities Development & Maintenance Selection & Harmonization Testing/Trial Implementation CertificationDeployment Goals What should be accomplished ? What are the standards? What standards to use? Show what can be accomplished Certify standards- based products Deploy standards- based products HIT Standards and Interoperability Framework Development Entities HIT Policy Committee HIT Standards Committee S&I Harmonization Framework Initiatives SDOs (e.g., HL7, SNOMED (IHTSDO), LOINC, ASC X12, NUBC, ISO TC215) IHE (Formerly HITSP, to be superseded pending ONC decisions) IHE Certification Entities (CCHIT, Drummond Group, Inc) PHIN IHE & PHDSC Deployment Workshops Standards Documents Use Cases, CDC ELR Projects PHII-APHL PHLIP PHLISSA, RCMT, PHIN Preparedness Report, etc. Standards HL7 2.x Implementa- tion Guides Interoperability Specifications Technical Frameworks Integration Profiles Test Reports Functional Profiles Certification Criteria Deployment Reports

PHIN Adaption of the ONC Standards and Interoperability Framework

HIT Standardization and PHDSC Projects HIT Standardiza- tion Phases Needs & Priorities Development & Maintenance Selection & Harmonization Testing /Trial Implemen- tation Certification Deploy- ment Goals What should be accomplished? What are the standards? What standards to use? Show what can be accomplished Certify standards- based products Deploy standards -based products Public Health Domains Undergoing HIT Standardiza- tion Biosurveillance Immunization ELR Public Health Reporting Newborn Screening Vital Records Biosurveillance Immunization ELR Public Health Reporting Newborn Screening Vital Records Biosurveillance Immunization ELR Public Health Reporting Newborn Screening Vital Records PH-Lab Public Health Reporting Hearing Vital Records PH-Lab Public Health Reporting Hearing Vital Records PH-Lab Hearing ONC Standards and Interopera- bility Framework Admin Data PHDSC ProjectsHITSP ProjectsAHIC/MU

HIT Standardization and PHDSC Projects HIT Standardiza- tion Phases Needs & Priorities Development & Maintenance Selection & Harmonization Testing /Trial Implemen- tation Certification Deploy- ment Goals What should be accomplished? What are the standards? What standards to use? Show what can be accomplished Certify standards- based products Deploy standards -based products Public Health Domains Undergoing HIT Standardiza- tion Biosurveillance Immunization ELR Public Health Reporting Newborn Screening Vital Records Biosurveillance Immunization ELR/PH-Lab Public Health Reporting Newborn Screening Vital Records Biosurveillance Immunization ELR/PH-Lab Public Health Reporting Newborn Screening Vital Records PH-Lab Public Health Reporting Hearing Vital Records PH-Lab Public Health Reporting Hearing Vital Records PH-Lab Hearing ONC Standards and Interopera- bility Framework Admin Data PHDSC ProjectsHITSP ProjectsAHIC/MU

Presentation Outline  Preliminary results of the CDC OSELS/PHDSC/APHL/AHIMA project for operationalizing HIT standards PH-Lab data exchanges  White Paper/Roadmap for PH-Lab Interoperability  Building PH-Lab Interoperability  HL7 Public Health Reporting Requirements Standard  IHE Integration Profile: Public Health Reporting- PH-Lab  HL7 Public Health Functional Profile - PH-Lab  PH-Lab and National Health IT Standardization Initiatives

Building PH-Lab Interoperability Standards Development  HL7 Public Health Reporting Requirements Standard (structured templates for representing jurisdiction-specific requirements) Standards Harmonization and Testing  IHE Integration Profile: Public Health Reporting- PH-Lab  Testing IHE Laboratory Profiles for Test Result Reports using CDA documents for selected conditions Certification of Standards-based HIT Products  HL7 Public Health Functional Profile - PH-Lab (functional requirements and conformance criteria for PH-Lab data exchange with clinical EHR)

Building PH-Lab Interoperability Standards Development  HL7 Public Health Reporting Requirements Standard (structured templates for representing jurisdiction-specific reporting requirements) Approved in May 2011 as an extension to the HL7 Healthcare Quality Measure Framework (HQMF) Standard -- joint work of the HL7 Structured Documents Workgroup and the HL7 Public Health & Emergency Response Workgroup Will be balloted at HL7 in Nov-Dec 2011

Building PH-Lab Interoperability Standards Harmonization and Testing  IHE Integration Profile: Public Health Reporting- PH-Lab  Describes PH-Lab data exchanges in the context of public health business processes for case/outbreak identification, investigation, and management.  Defines Clinical Data Architecture (CDA) documents for selected 5 conditions (antrax, tularemia, hep-B, TB, influenza) using RCMT  Defines interoperability standards for data exchanges Published for Public Comments in June 2011 by the IHE Quality, Research and Pubic Health Committee Currently under the Committee Review

Building PH-Lab Interoperability Standards Harmonization and Testing (Continued)  Testing IHE Laboratory Profiles for Test Result Reports using using Clinical Data Architecture (CDA) documents for selected conditions  We will specify PH-Lab Report content for testing IHE-Lab Integration Profiles in CDA documents for selected 5 conditions (antrax, tularemia, hep-B TB, influenza)  Testing will be conducted at the IHE Connectathon, January 2012

Building PH-Lab Interoperability Certification of Standards-based HIT Products  HL7 Public Health Functional Profile – PH-Lab will define functional requirements and conformance criteria of the HL7 EHR Functional Model for generating laboratory orders and receiving results reports The Profile will be developed by the PHDSC EHR-Public Health Task Force during August-November 2011 Will be Balloted at HL7 in Nov-Dec 2011 and finalized by May 2012  Certification Criteria for PH-Lab data exchanges will be defined  We will work towards establishing the PH-Lab Certification Process with PHIN and the national certification entities

PHDSC PH-Lab Project by HIT Standardization Phases, Products and Entities HIT Standardization Phases Needs & Priorities Development & Maintenance Selection & Harmonization Testing/Trial Implementation CertificationDeployment Goals What should be accomplished ? What are the standards? What standards to use? Show what can be accomplished Certify standards- based products Deploy standards- based products HIT Standards and Interoperability Framework Development Entities HIT Policy Committee HIT Standards Committee S&I Harmonization Framework Initiatives SDOs (e.g., HL7, SNOMED (IHTSDO), LOINC, ASC X12, NUBC, ISO TC215) IHE (Formerly HITSP, to be superseded pending ONC decisions) IHE Certification Entities (CCHIT, Drummond Group, Inc) PHIN IHE & PHDSC Deployment Workshops Standards Documents Use Cases, CDC ELR Projects PHII-APHL PHLIP PHLISSA, RCMT, PHIN Preparedness Report, etc. Standards HL7 2.x Implementa- tion Guides Interoperability Specifications Technical Frameworks Integration Profiles Test Reports Functional Profiles Certification Criteria Deployment Reports On-going Activities ( 2008-now) Developed methodology for public health participation in HIT standards development & harmonization. New Activities ( ) Develop methodology for public health participation in HIT product testing and certification Future Activities Develop methodology for evaluation of standard-based HIT products (standards-based HIT products deployment) CDC-PHDSC-APHL-AHIMA PH-Lab Project White Paper on PH-Lab Interoperability Year 1Year 2Year 3 Harmonize Needs & StandardsTestCertify & Deploy

Presentation Outline  Preliminary results of the CDC OSELS/PHDSC/APHL/AHIMA project for operationalizing HIT standards PH-Lab data exchanges  White Paper/Roadmap for PH-Lab Interoperability  Building PH-Lab Interoperability  HL7 Public Health Reporting Requirements Standard  IHE Integration Profile: Public Health Reporting- PH-Lab  HL7 Public Health Functional Profile - PH-Lab  PH-Lab and National Health IT Standardization Initiatives

PH-Lab and National Health IT Standardization Initiatives  ONC S&I Public Health Reporting Initiative  ONC S&I Laboratory Reporting Interchange (LRI) Initiative and Public Health Laboratory Report Subgroup  ONC S&I Transition of Care Initiative  ONC S&I Population Query Initiative  Federal Health Architecture Initiative

Building PH-Lab Interoperability Join us at the PHI Conference Interoperability Showcase for demonstrations of interoperability solutions for PH-Lab data exchanges

For more information please contact Centers for Disease Control and Prevention 1600 Clifton Road NE, Atlanta, GA Telephone, CDC-INFO ( )/TTY: Web: