Quality, Research & Public Health (QRPH)

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1 Quality, Research & Public Health (QRPH) QRPH Committee Members & Planning Co-Chairs: Michelle Williamson, Centers for Disease Control and Prevention National Center for Health Statistics & Didi Davis, President/Serendipity Health, LLC

2 The IHE Development Domains 17 Years of Steady Evolution Dentistry since 2010 Endoscopy since 2010 Pharmacy since 2009 Pathology since 2006 Eye Care since 2006 Quality Research & Public Health since 2007 Radiology since 1998 (Healthcare) IT Infrastructure since 2003 Cardiology since 2004 Laboratory since 2004 Radiation Oncology since 2004 Patient Care Coordination since 2004 Patient Care Devices since 2005

3 IHE Leveraged Worldwide Initiative Location Profiles Leveraged Alberta Health Services Canada PIX, PDQ, XCA, XDS.b, XDS-I Care Connectivity Consortium United States XCA, XCPD ehealth Ontario Canada PIX, PDQ, XDS.b, XDS-I EHR/HIE Interoperability Workgroup United States HPD, XDS.b epsos Europe XCA, XUA Healtheway ehealth Exchange United States XCA, XCPD Meaningful Use United States XDM, XDR, PRPH-CA New York ehealth Collaborative United States PIX, PDQ, XDS.b, XDS-MS ONC S&I Framework United States XDM, XDR, XDS.b, MHD, RFD, PRPH-CA, HPD, SDC and many more...

4 Agenda Time QRPH Profile Presenters 10:00-10:05 Introduction Michelle Williamson 10:05-10:15 Structured Data Capture (SDC) Vijay Shah 10:15-10:20 SDC Q&A Nichole Drye Mayo Public Health (PH Profiles) 10:20-10:30 Family Planning Johanna Goderre Jones 10:30-10:45 Vital Events Reporting Michelle Williamson Lori Fourquet 10:45-10:55 Healthy Weight Brittani Harmon Lori Fourquet 10:55-11:00 Cancer Reporting Wendy Blumenthal 11:00-11:15 Early Hearing Detection and Intervention John Eichwald Lisa Nelson 11:15-11:35 PH Profile Q&A Nichole Drye Mayo 11:35-11:50 Research Profiles and White Papers Landen Bain Alana St. Clair 11:50-11:55 Research Profiles and White Papers Q&A Nichole Drye Mayo 11:55-12:00 Timeline and Next Steps Michelle Williamson

5 Housekeeping Items Need to keep to the allotted time as much as possible to ensure all profiles will be presented Enter questions in the chat window to be addressed during the Q&A periods If we have more questions than time, the questions will be forwarded to the profile editors for follow up

6 Structured Data Capture (SDC) Farrah Darbouze, Public Health Analyst, Office of Standards & Technology, ONC/HHS Vijay Shah, Assistant Director, JBS International, Inc. Learning Objectives: Describe the mechanism that enables the collection of structured data from EHRs so it can be stored for merger with comparable data for various purposes e.g. electronic Case Report Form, adverse event reporting, collecting information for determination of coverage, etc. Describe the mechanism that enables the collection of structured data from EHRs so it can be stored for merger with comparable data for various purposes e.g. electronic Case Report Form, adverse event reporting, collecting information for determination of coverage, etc. Define what an SDC compliant Form is and how it can be used to collect information in a more uniform and systematic manner. Describe how data collected in an SDC Form can be submitted to the end system in a light-weight manner keeping the form context information. Discover how using the SDC Profile makes sharing information across various domains more efficient and more effective.

7 Structured Data Capture Conceptual Workflow 1 Sends request for form/template 2 Sends requested form/template Form/ Template Repository CDE Library Form Library Metadata Source SDC Scope EHR System 3 Converts, populates & displays form Specified Form/Template Actor Key Displayed Form Forms Filler Forms Manager External Repository 4 Fills, stores/transmits structured data x John Doe x xx x x Structured Captured Data x 5 External Data Extract, Transform, & Load Data by form/ template

8 SDC Profile - Workflow

9 SDC Profile Workflow showing Auto-population & Pre-population

10 SDC Profile Salient Features Extends IHE RFD profile by defining the details for <RetrieveFormRequest> and <SubmitFormRequest> elements SDC Form Definition introduces a standardized set of attributes describing the semantics and syntax of a form design, to allow consistent rendering in various Health IT systems Provides a Schema that can be used to validate SDC Forms easily SDC Packages defines content of the self-serving packages that allows system to utilize form definition and accompanying mapping information, administrative information, and supplemental data to render the form without requiring any additional knowledge on how Form Manager/Form Processor may have created the form Provides guidance on other common modes of exchanging forms using HTML forms, URLs, etc.

11 SDC Profile Salient Features (Contd.) SDC Submission Data defines a uniform and standardized manner in which form data can be sent to Form Receiver/Form Archiver The Form Filler only need to send the relevant data, without having to submit the actual form, thus making the submission very light-weight Provides a Schema that can be used to validate SDC submitted data easily Form Filler can exchange data and interoperate with any SDC compliant Form Receiver/Form Archiver, even if they don t have any prior knowledge of the form itself Promotes interoperability across various domains through use of standardized forms and common data elements

12 Questions on the Structured Data Capture profile?

13 Family Planning (FP) Johanna Goderre Department of Health and Human Services Office of Population Affairs Learning Objective: Attendees will learn about the family planning profile that will help providers captured structured data critical for a range of reproductive and sexual health clinical performance measures and how their electronic health record systems can interoperate with quality reporting data systems.

14 Title X: Diverse and wide network The 10 HHS Federal Regions 8.6 million encounters annually 4.8 million clients Service delivery sites in Sub recipients 50+ States, territories, DC monitored by 93 Grantees monitored by 20 Regional Office Family Planning staff Supported by 10 Regional Health Administrators 5 National Training Centers 1 HQ * 2012 FPAR service data 2013 staffing estimates

15 Family Planning Annual Report (FPAR) FPAR 2.0 Repository Site A Regional FPAR system Grantee Data System Site J Site B Site C Site D Site E Site F State HIE Site G Site H Site I

16 Providers seeking support of FP content ~4,000 Title X service sites Family Planning specialists National Family Planning and Reproductive Health Association Members operate or fund a network of nearly 5,000 health centers and service sites More than 8,000 publicly funded family planning centers National network of unified providers at 700 health centers Primary care and other health centers Quality Family Planning guidelines & performance measures aimed at broad clinical audience

17 Emphasis on Quality Framework Structured data elements designed to serve a range of performance measures Quality Family Planning Recommendations National Quality Forum & Meaningful Use: Chlamydia Screening Measures in development for NQF Family Planning Annual Report Center for Medicare & Medicaid Services, Children s Health Insurance Program Maternal and Infant Health developmental measures HHS common core indicators for HIV prevention, treatment, and care services Gavin, et al. Providing Quality Family Planning Services: Recommendations of CDC and US Office of Population Affairs. MMWR Apr PMID:

18 Robust review of the FP profile during public comment 656 comments from over 80 organizations

19 Family Planning Profile at 2015 Connectathon

20 IHE profiles: RFD & FP Retrieve Form for Data Capture (RFD) provides a method for gathering data within a user s current application to meet the requirements of an external system. RFD supports the retrieval of forms from a form source, display and completion of a form, and return of instance data from the display application to the source application. In addition, RFD provides a mechanism to amend data that was previously captured. IT Infrastructure Technical Framework, Volume 1 The Family Planning (FP) Profile describes the content and format to be used within the pre-population data part of the Retrieve Form Request transaction from the RFD Integration Profile. It is expected that the Form Filler and Form Manager will implement the RFD transaction as specified in the RFD, and this profile does not include any additional constraints or extensions on the RFD transactions.

21 Summary Market Broadly applicable to all health professionals delivering family planning & related preventive health services Community setting (health departments, independent clinics, health centers) Questions? Subscribe to our blog

22 Vital Events Reporting Michelle Williamson, Senior Health Informatics Scientist, CDC/National Center for Health Statistics Lori Fourquet, ehealthsigns Learning Objective: Attendees will learn about the Birth and Fetal Death Reporting-Extended (BFDR-E) and Vital Records Death Reporting (VRDR) that support prepopulation of data from electronic health record systems to forms and enable interoperability with states electronic vital registration systems for birth, death and fetal death reporting to meet Federal, state and local government reporting requirements. The primary driver for implementation is to improve the timeliness, quality and accuracy of vital statistics data that are widely used to monitor and improve the nation s health.

23 QRPH: Profiles Enable Vital Events Reporting for Birth Certificate, Death Certificate and Fetal Death Vital Events reporting for births, deaths and fetal deaths include: Wide range of demographic, medical, and geographic data derived from birth certificates, death certificates and fetal death report For example, in the US, over six million vital records events are reported annually covering the 57 registration areas: 50 states, 2 cities, and 5 U.S. territories Vital statistics data are widely used to monitor and improve the nation s health For example, the data may be used to track and explain trends: Cesarean delivery Preterm and low birth weight births Causes of infant death and disparities

24 Electronic Health Record (EHR) and Vital Record (VR) Systems Information Exchange Capturing birth, fetal death and death data in EHR systems Improving the timeliness, accuracy, and completeness of vital records data Electronic exchange using HL7 and IHE based standards

25 QRPH: Profiles Enable Vital Events Reporting for Birth Certificate, Death Certificate and Fetal Death Birth and Fetal Death Reporting-Extended (BFDR-E) Supports pre-population of data from EHRs to birth certificate and fetal death reporting forms to meet Federal, state and local reporting requirements Enables interoperability between EHRs and Electronic Birth Registration Systems and Electronic Fetal Death Registration Systems Vital Records Death Reporting (VRDR) Supports pre-population of data (using a Medical Summary) from EHRs to death reporting forms to meet Federal, state and local reporting requirements Enables interoperability between EHRs and Electronic Death Registration Systems BFDR-E and VRDR Utilize a Form Filler and Form Manager to implement the ITI Retrieve Form for Data Capture (RFD) Profile Defines a mechanism to transform form submission data and transmit it as a standard HL7 v2 message or CDA

26 QRPH: Birth and Fetal Death Reporting Extended (BFDR-E) Basic Process Flow for BFDR-E

27 QRPH: Vital Records Death Reporting (VRDR) Basic Process Flow for VRDR

28 Healthy Weight (HW) Brittani Harmon, CDC Lori Fourquet, e-healthsign Learning Objective: Attendees will learn about the Healthy Weight profile that supports capture and communication of information supporting care management and population health monitoring of healthy weight. Flexibility in the capture and communication of structured data allows for multiple implementation approaches to maximize the ability to communicate healthy weight information. This includes support for communication of Occupational Health information and healthy weight risk factors.

29 Informing programs, policy, systems, environments, resource allocation, priorities, patient care quality improvements MEDICAL PROVIDERS Capturing quality HW data in EHR systems, improving care Electronic Health Record (EHR) Healthy Weight (HW) Information Exchange PUBLIC HEALTH Establishing a HW surveillance system HWS (CDA) Electronic exchange using HL7 and IHE-based standards HWS (CDA), HWFeed (HL7 V2.5.1) Impact

30 Profiles & Technical Frameworks QRPH: Profile Healthy Weight (HW) Height/Weight measures, Counseling, Care Plan and Coordination, and Clinical Surveillance Assists with the overweight and obesity identification, intervention, care management and clinical surveillance Identifies standards and data requirements for healthy weight monitoring and intervention Supports healthy weight goals, resources, and care plan for healthy weight improvements available to all authorized providers of care Uses several different mechanisms for capturing and communicating that information Enables public health and population health surveillance to assure access to appropriate resources for healthy weight management Enables communication of detailed Occupational Health information

31 Profiles & Technical Frameworks QRPH: Profile Healthy Weight (HW) Basic Process Flow for Healthy Weight (HW)

32 Physician Reporting to a Public Health Repository Cancer Registry (PRPH-Ca) Wendy Blumenthal Centers for Disease Control and Prevention Learning Objective: Attendees will learn about the IHE Profile Physician Reporting to a Public Health Repository Cancer Registry (PRPH-Ca) that supports implementation of standardized transmission of data about a patient s cancer case from an ambulatory healthcare provider EHR to the public health central cancer registry. The primary purpose for implementation is to increase the security, completeness, timeliness and accuracy of cancer surveillance data for improved public health.

33 Profiles & Technical Frameworks QRPH: PRPH-Ca Profile Status Trial Implementation Physician Reporting to a Public Health Repository Cancer Registry Defines the CDA R2-based content for physicians to report a diagnosis and/or treatment of a cancer patient to the public health cancer registry Provides standards for implementation of electronic reporting to improve completeness, timeliness and accuracy of cancer surveillance data critical to cancer control activities aimed at reducing the morbidity and mortality of cancer Defines Content Creator Healthcare Provider Defines Content Consumer Public Health Cancer Registry Fulfills state legal obligations to report cancers to state cancer registries Provides a single, consistent method that allows efficient and accurate exchange of information while reducing the burden on EMR systemspecific or registry-specific implementations

34 Cancer Reporting from Physician EHRs to Central Cancer Registries

35 Profiles & Technical Frameworks QRPH: PRPH-Ca Profile Status Trial Implementation Leveraging PRPH-Ca profile Cancer reporting from eligible professionals (EP) to public health central cancer registries is a Stage 2 Meaningful Use (MU) menu objective Using the IHE profile, CDC developed the Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer Registries, August 2012 This implementation guide is identified by the Office of the National Coordinator for Health Information Technology (ONC) as the standard for EPs to meet the cancer reporting menu objective At least 14 EHR vendors are currently certified to meet the standards identified in the IG Profile can also be used for data exchange between providers, even though the primary use case is for reporting to public health central cancer registries

36 Profiles & Technical Frameworks Physician Reporting to a Public Health Repository Cancer Registry (PRPH-Ca) Actor and Transaction diagram

37 Early Hearing Detection and Intervention (EHDI) John Eichwald, Branch Chief Child Development and Disability (CDD) Branch Division of Human Development and Disability (DHDD) National Center on Birth Defects and Developmental Disabilities (NCBDDD) Centers for Disease Control and Prevention (CDC) Lisa Nelson, Principal Consultant Lantana Consulting Group Learning Objectives: Learn about a new Hearing Plan of Care profile that will help providers capture hearing screening results and information about a newborn and create a plan of care that provides clinical decision support to clinicians performing follow-up care. See how information captured by hearing screening devices and electronic medical record systems can be used to produce a standard Hearing Plan of Care. Discover why using new Hearing Plan of Care standards make sharing information with Public Health and care providers more efficient and more effective.

38 The Early Hearing Detection and Intervention Family of Profiles Discover why using the EHDI family of profiles makes sharing information with Public Health and care providers more efficient and more effective. Newborn Admission Notification Information (NANI) Capture, share and receive birth notifications Quality Measure Execution for Early Hearing (QME-EH) Generate and share patient level Quality Data Reports used to compute the MU quality measure Early Hearing Detection and Intervention - Workflow Document (EHDI-WD) Create, update and share a document that tracks, across multiple organizations, the progress of the hearing screening process and care plan generation Early Hearing Detection and Intervention (EHDI) Leverage EHR data to create a plan of care that provides clinical decision support for clinicians performing follow-up care Learn about the next generation Hearing Plan of Care (evolution of the Early Hearing Care Plan) See how results from a hearing screening devices can be captured automatically.

39 Newborn Admission Notification Information (NANI) Status - Trial Implementation Hospital EHR Content Public Health Early Hearing Detection and Intervention (EHDI) Program

40 Newborn Admission Notification Information (NANI) What does NANI provide? Timely newborn demographic information to public health Quality Measure denominator for hospital newborn admissions Helps to: Ensure care for all babies Evaluate program quality Decrease duplicate data entry

41 Quality Measure Execution for Early Hearing (QME-EH) Status - Trial Implementation Hospital EHR Content Patient Level Quality Data Report (QRDA-1) Public Health Early Hearing Detection and Intervention (EHDI) Program Aggregate Measure Data Report (QRDA-3)

42 Quality Measure Execution for Early Hearing (QME-EH) What does QME-EH provide? Specific Implementation guidance on how to create the HL7 Quality Report Document Architecture (QRDA) standard Digital Quality Reports to support the MU2 e-measure for EHDI Patient Level, QRDA Category 1 Aggregate Measure, QRDA Category 3

43 Hearing Plan of Care (HPoC) Status - Trial Implementation (Evolution of EHCP) Hospital EHR Content Hearing Plan of Care (HPoC) Public Health Early Hearing Detection and Intervention (EHDI) Program Hearing Screening Results Human and Machine readable Next steps for hearing care Screening Outcomes Risk Indicators Problems Procedures Primary Care or Specialist

44 Hearing Plan of Care (HPoC) What does HPoC provide? Communication of results from a hearing screening devices, and screening outcome Re-use of EHR data to create a plan of care that provides clinical decision support for clinicians performing follow-up care Human readable as well as computer readable information Hearing plan of care that captures the longitudinal plan for hearing care Designed to be part of a holistic Care Plan

45 Birthing Facility EHDI-Workflow Document (EHDI-WD) Hearing Screening Device Status - Trial Implementation Medical Home State EHDI Program Specialist Federal Agency Standards-based workflow tracking across organizations running different systems

46 EHDI-Workflow Document (EHDI-WD)

47 The Early Hearing Detection and Intervention Family of Profiles What do the EHDI standards provide? A more efficient and more effective way to share information with public health and care providers Reduced data entry, error reduction Reuse of EHR data, greater consistency Better communication and follow-up A longitudinal hearing plan of care Foundation for standards-based Care Plan creation and reconciliation Workflow tracking across organizations

48 Questions on the suite of Public Health profiles?

49 Research Profiles and White Papers Landen Bain, Clinical Data Interchange Standards Consortium (CDISC) Alana St. Clair, CDISC Learning Objective: Attendees will learn about a set of six IHE profiles that were codeveloped with CDISC, a Standards Development Organization in the medical research space which has worked with QRPH for a number of years. These profiles -- CRD, DSC, RPE, CRPC, DEX, RM comprise a body of work which CDISC calls Healthcare Link, the intent of which is to create all the capabilities needed for EHR-enabled research.

50 Profiles & Technical Frameworks Research Profiles Status Trial Implementation Clinical Research Document (CRD) Defines pre-population data for the clinical research use case of an IT Infrastructure (ITI) Retrieve Form for Data Capture (RFD) transaction Enables Electronic Medical Records (EMRs) to provide useful data research systems such as Electronic Data Capture (EDC) and Clinical Trial Management Systems (CTMS) Use of CRD, in conjunction with RFD, greatly simplifies the data capture step of clinical research participation at healthcare sites Drug Safety Content (DSC) Defines the content to be used by a drug safety reporting use case in conjunction with RFD Impacts the EMR and the drug safety reporting system and, ultimately, the MedWatch system of the Food and Drug Administration (FDA) DSC enables a healthcare provider to report a drug related adverse event from within an EMR session. This capability has been shown to increase the frequency with which physicians report drug related problems

51 Profiles & Technical Frameworks Clinical Research Document Process Flow

52 Profiles & Technical Frameworks QRPH: Retrieve Process for Execution (RPE) Status Trial Implementation RPE enables a healthcare provider to access a process definition, such as a research protocol, and to execute automated activities, without leaving an EMR session RPE impacts the EMR and systems hosted by quality, research and public health agencies which need to direct healthcare activities The benefits of RPE include greatly simplified workflow at healthcare sites that enact quality, research or public health activities Trial implementation status, with one year of testing performed

53 Profiles & Technical Frameworks Retrieve Process for Execution (RPE) actor and transaction diagram

54 Profiles & Technical Frameworks QRPH: Clinical Research Process Content (CRPC) Profile Status Trial Implementation Research protocols guide the conduct of trials. Many of the interventions and clinical activities pertaining to a study are performed within healthcare organizations and often involve integrated use of the clinical electronic health record system Protocols are complex and in order to appropriately handle the scheduling, ordering, and billing related to those protocols, the EHR must be able to communicate certain information with the systems that manage the study The existing IHE profile Retrieve Process for Execution (RPE) acts as a general framework providing messaging interactions, that could be used to convey the necessary information. The proposed research content profiles utilize RPE as a framework and solve the issues of exchanging detailed content specific to the research domain

55 Profiles & Technical Frameworks Clinical Research Process Content (CRPC) Use Case Time consuming instantiation of the same complex research protocol definition in multiple systems Study Orders Clinic and Ancillary Scheduling Integrated EMR Functionality Clinical Orders and Services Study Staff and Research Study Management System Study Staff and EMR Analyst(s) Health System Billing

56 Data Element Exchange (DEX) Status Trial Implementation EHRs contains data elements that can be used to populate research case report forms DEX leverages the power of an ISO/IEC Metadata Registry standard to apply mappings earlier in the process, at the point of form design DEX will create a customized map of the elements in a particular case report form to the corresponding elements in the EHR export. The metadata registry maintains the exact interactions between the research and healthcare data elements, and will provide an exact map by which data can be extracted from the pre-population data set

57 Data Element Exchange (DEX) DEX Actor Transaction Diagram DEX maps secondary use domain data to healthcare data elements RetrieveDataElementList [QRPH -43] Metadata Consumer RetrieveMetadata [QRPH -44] Metadata Source

58 Research Matching (RM) Status Trial Implementation RM specifies methods of matching patients and investigators with appropriate clinical research studies RM specifies a method for publishing research process definitions to interested EHR systems

59 Research Matching (RM) RM Actor Transaction Diagram Research Information Consumer Retrieve Research Study List [QRPH-40] Retrieve Process Definition [QRPH 22] Initiate Process [QRPH 25] Research Information Subscribe [QRPH-41] Research Information Source Research Information Notify [QRPH-42] RM matches patients and investigators to appropriate clinical research studies

60 2013 QRPH White Papers EHR-enabled Research White Paper Proposed and accepted for development in cycle. This white paper will integrate all research-related profiles into a consolidated profile that can be used to automate all aspects of clinical research that are related to the EHR. Consolidated Profile White Paper Discussion of the EHR-enable Research White Paper led to a more general approach: Consolidated Profile White Paper.

61 Questions on the research profiles or white papers?

62 IHE International Membership is Free How to Participate in QRPH? Apply for IHE International Organizational Membership Visit: Approved monthly by IHE International Board Review IHE's 600+ Organizational Members Participate in IHE Domains & Committees IHE Organizational Members only 13 Clinical and Operational Domains Each Domain has one planning and one technical committee or one joint committee Non-members participate in comment periods and implement IHE Technical Frameworks

63 IHE Profiles Drafted & Revised Test at IHE Connectathons Published For Public Comment Trial Implementation Posted months Publish in IHE s Produc Registry IHE Technical Framework Developed months 6-13 Demonstrate at a Profile Selection by Committees IHE Call for Proposals Opens months 1-5 IHE Improves, Safety, Quality and Efficiency in Clinical Settings Install Interoperable products in Clinical Settings worldwide

64 IHE QRPH Profile Cycle Stages Participation Status Open Date Close Date Learn More Planning Committee Call for Proposal Planning and Technical Profile Selection IHE Profiles drafted in IHE Technical Committee New QRPH Profile Work Public Comment QRPH Trial Implementation Published IHE World Summit - Building Bridges to Better Health IHE USA Connectathon Registration IHE USA Connectathon & Conference (1/28) IHE Europe Connectathon Open Aug Sept Profile_Proposal_Process Member Only Sept Nov Quality,_Research_and_Public_Heal th_planning_committee Member Only Jan May Quality,_Research_and_Public_Heal th_technical_committee Open June 2015 July Public_Comment_Process Open N/A Aug meworks/#qrph Open September 11, 2014 September 13, / Open Aug. 26, 2014 Oct Open Jan. 26, 2015 Jan. 30, Open April 20, 2015 April 24, ectathon

65 Important Links and Information Apply for IHE International s Free Membership: Visit: General Questions/Information qrph@ihe.net Google Group Website Wiki g_committee

66 Important Links and Information IHE Technical Frameworks: IHE Profiles developed by QRPH: ublic_health 2014 IHE Webinar Series: for the full list of domain webinars All webinar recordings and slide decks will be posted Integration Statements/Product Registry:

67 Final questions?

68 Thank you for attending the QRPH Educational Webinar!

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