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Making really good sausage Evolving standards in public health case reporting.

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Presentation on theme: "Making really good sausage Evolving standards in public health case reporting."— Presentation transcript:

1 Making really good sausage Evolving standards in public health case reporting

2 Session plan Harmonizing Content of Public Health Surveillance Systems: Lessons Learned from the ONC Standards and Interoperability (S&I) Public Health Reporting Initiative (PHRI) Progress Toward a Reportable Conditions Knowledge Management System (RCKMS) Electronic Reporting of Communicable Diseases: Demonstrating the Utility of a Constrained Public Health Case Report in HL7 Clinical Document Architecture (CDA) 6/11/2013 Progress towards RCKMS CSTE 2013 Annual Meeting 2 WITHDRAWN

3 Progress Toward a Reportable Conditions Knowledge Management System (RCKMS) Rita Altamore - Washington State Department of Health Laura Conn - Centers for Disease Control and Prevention Catherine Staes - University of Utah Shu McGarvey – Northrup Grumman / CDC CSTE 2013 Annual Meeting

4 Where we were this time last year CSTE-CDC ELR Taskforce Standards Workgroup – RCMT a start – Need more Funded RCKMS project had just started – May 2012 be careful what you wish for… 4 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

5 RCKMS Objectives (1) Serve as a current, authoritative source of information about what is reportable to each U.S. jurisdiction, for use by public health reporters (e.g., clinicians, laboratories, hospitals). Support the Meaningful Use population health objective of Reportable Laboratory Results by supporting reporting by Eligible Hospitals (EPs). Decrease the time and effort invested by public health reporters as they strive to comply with ever-changing reporting requirements. Improve timeliness and completeness of public health reporting. Serve as a resource for automated case detection and case reporting systems. 5 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

6 RCKMS Objectives (2) Tie together the interoperability standards needed to enable electronic reporting (e.g., terminology, messaging, document, services, transport). Support major national initiatives such as the revised International Health Regulations, Homeland Security Presidential Directive 21, the Pandemic and All-Hazards Preparedness Act, and the Health Information Technology for Economic and Clinical Health (HITECH) Act, enacted as part of the American Recovery and Reinvestment (ARRA) Act of Make explicit the variation in reporting requirements that now exists, enabling review by stakeholders with the goal of reducing variation determined to be unnecessary. 6 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

7 What’s happened since then Implementation of first phase of RCKMS – Initially funded through 1/2013 – Additional funding extends work through 6/2013 Steering committee, working groups Stakeholder representation – PH organizations (CDC, CSTE, NACCHO, APHL) – Epidemiologists, laboratorians, informaticists – Vendors, healthcare provider organizations 7 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

8 RCKMS Steering Committee Co-leads – Rita Altamore-Washington State DOH – Laura Conn-CDC/PHSIPO Members – Shandy Dearth-Marion County HD/NACCHO – Karen Eilbeck-University of Utah – Shaun Grannis-Regenstrief Institute – Janet Hamilton - Florida DOH /CSTE – Leslie Ann Helmus-Virginia DOH – Ruth Ann Jajosky- CDC/PHSIPO – Riki Merrick-iConnect Consulting/APHL – Ninad Mishra-CDC/PHITPO – Catherine Staes-University of Utah CDC Project Sponsors – Bob Pinner-CDC/NCEZID – Kathy Gallagher- CDC/PHSIPO 8 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

9 RCKMS Subgroup Structure Representation from the very diverse set of stakeholder groups – Members provide expertise and review and approve deliverables Requirements – Sunanda McGarvey / Julie Lipstein Jurisdictional Validation for Pilot Content – Catherine Staes / Rita Altamore Healthcare/ Vendor Partner Validation for Pilot – Brian Labus / Shu McGarvey Knowledge Representation – Karen Eilbeck/ Catherine Staes; facilitator - Sundak Ganesan Governance – Rita Altamore / Laura Conn 9 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

10 RCKMS Pilot Project Discussions at CSTE 2012 – Question: can PH be ready for case reporting in MU Stage 3? – Answer: yes, if we collectively commit to making it so Demonstrate capability – Pilot project – Information PH  clinical setting Clinical setting  PH pilot project already underway PHDSC Clinical Document Architecture (CDA) for Public Health 10 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

11 RCKMS pilot: reportable conditions Pertussis – Part of CDA for PH pilot project Tuberculosis – Part of CDA for PH pilot project Blood lead level – Non-infectious condition – Reportable throughout the US – Known variation in reporting requirements 11 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

12 RCKMS pilot: jurisdictions Colorado Delaware – CDA for PH pilot project participant (pertussis) New York City New York State – CDA for PH pilot project participant (pertussis) San Diego County (pertussis only) – CDA for PH pilot project participant (pertussis) Utah Washington State 12 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

13 Information gathered (1) Information about the reportable event, including: – Condition name – Location to which the specifications apply (e.g., Utah, New York City) – Types of reporters for whom the information is relevant (health care provider, hospital, laboratory). Other types of reporters exist, scope of pilot limited to these – Contact information about the public health entity that authored the content authenticated the content is responsible for the rules reflected by the content 13 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

14 Information gathered (2) Reporting logic: when to generate a case report or laboratory report – Widely varying types of criteria, including: patient age, pregnancy status, diagnoses/problems, laboratory test orders/results, treatments, epidemiologic information – Basis for reporting: Location of the person’s residence Location where clinical care was delivered Location of the laboratory. 14 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

15 Information gathered (3) Reporting actions – Reporting time frame (e.g., immediately, two business days, monthly) – For each type of reporter: Required reporting method ~ OR ~ When more than one method is available, which one is (or which ones are) preferred – Specimen submission requirements 15 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

16 Information gathered (4) Methods for PH to receive a report – Phone and fax numbers – URLs for reporting forms – Contact information to set up ELR Links to additional information – Jurisdictional reporting laws and rules – CSTE position statements – Clinical and other guidance 16 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

17 Phase 1: out of scope Information to guide a clinician in determining a patient’s diagnosis Information to support public health epidemiologists in case classification (e.g., suspect, probable, confirmed) 17 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

18 Accomplishments Data collection and persistence Web site development Standardized output – Human readable – Machine processable Evaluation by a diverse set of users – Vendor engagement Subscriptions/notifications 18 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

19 Testing scenario #1 You are a laboratory located in Utah and have a positive result for TB, which you believe needs to be reported to public health. Your lab has not yet implemented ELR. You would like to determine how quickly the report needs to be sent, to whom it should be sent and the methods of reporting that are available. Since you don’t do ELR, you also need ready access to the report form to fill out. Finally, you’d like to review the list of lab criteria that Utah has specified as sufficient for reporting. 19 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

20 Testing scenario #2 You are a healthcare provider in Utah and have a patient with night sweats and positive tuberculin skin test. You suspect TB, but are not sure if it should be reported to public health. You’d like to review Utah’s reporting criteria for Suspect TB to determine if a report should be sent. 20 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

21 Testing scenario #3 You are pediatrician in Delaware and have just seen an 18 month old female with a cough, and inspiratory whoop. You believe the symptoms are suggestive of pertussis and would like to know if this should be reported. 21 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

22 Testing scenario #4 You are a laboratory located in Denver and have lab results showing blood lead concentration of 18 ug/dl in a 15 year old adolescent. The patient was a resident of Utah and was seen in Utah, but the laboratory testing was done in Denver. You would like to know if this is reportable to public health. If it is reportable, you’d like to know how quickly it should be reported, what should be included in the report, and if the report can be faxed. You’d also like to know if it should be sent to the state, or the local health department. 22 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

23 RCKMS pilot application – criteria set 1 23 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

24 RCKMS pilot application – criteria set 2 24 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

25 RCKMS pilot application – test value set 25 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

26 RCKMS pilot application – links and references 26 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

27 Challenges Collecting the information – Case reporting -- not case classification / case notification Representing the information in data structures – Complexity – Criteria statements not designed for computing – Variation Representing the information for human readers Representing the information for EHRs 27 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

28 Variation Session at CSTE 2012 – Variation in reporting requirements: how bad is the problem / what are the opportunities for prevention and treatment? – Well attended, good discussion – Bottom line: Collective yawn RCKMS staff team got migraines – Even with only 7 pilot jurisdictions, huge variation 28 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

29 Variation Relevant Jurisdiction Blood lead level Patient’s Age Reporting timeframe Utah ≥10mg/dLAny60 days < 10mg/dLAnyNo action – not reportable Colorado ≥10mg/dL≤18 years7 working days < 10mg/dL≤ 18 years30 days ≥ 25mg/dL> 18 years30 days < 25mg/dL> 18 yearsNo action – not reportable Washington ≥ 10mg/dL≤15 years2 working days < 10mg/dL≤ 15 years1 month ≥25mg/dLAny2 working days < 25mg/dL> 15 years1 month 29 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

30 Problematic criterion statements At least one of the following: prolonged productive cough, night sweats, fever, weight loss, or [other Not otherwise specified clinical abnormality- such as wound that won't heal or enlarged pericardium, etc] AND other diagnoses have already been ruled out. Abnormal chest radiograph showing clinical manifestations described in the Red Book for findings suggestive of TB, in the absence of another diagnosis. High complexity, even for human reader Hard (impossible?) to render in computable form 30 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

31 CSTE position statement - pertussis Report any illness to public health authorities that meets any of the following criteria: 1. An acute cough illness of any duration with an inspiratory whoop 2. Any person with isolation of Bordetella pertussis from a clinical specimen or a positive PCR test for B. pertussis 3. Any cough illness greater than 2 weeks duration in a person who is a contact of a laboratory-confirmed pertussis case. 4. Any cough illness greater than 2 weeks duration in a person who is a member of a defined risk group during an outbreak. 5. A person whose healthcare record contains a diagnosis of pertussis. 6. A person whose death certificate lists pertussis as a cause of death or a significant condition contributing to death. 31 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

32 CSTE Table VI-B for pertussis CriterionReporting Clinical Evidence Cough (any duration)N Cough > 2 weeks durationN Inspiratory whoopN Healthcare record contains a diagnosis of pertussis S Death certificate lists pertussis as a cause of death or a significant condition contributing to death S Laboratory Evidence Isolation of Bordetella pertussis from a clinical specimen S Positive PCR for B. pertussisS Epidemiologic Evidence Contact with a laboratory-confirmed pertussis case O Member of a defined risk group during an outbreak O S = This criterion alone is Sufficient to identify a case for reporting. N = All ”N” criteria in the same column are Necessary to identify a case for reporting. O = At least one of these “O” (Optional) criteria in each category (i.e., clinical evidence and laboratory evidence) in the same column—in conjunction with all “N” criteria in the same column—is required to identify a case for reporting. (These optional criteria are alternatives, which means that a single column will have either no O criteria or multiple O criteria; no column should have only one O.) 32 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

33 Drawing the line What makes a logic set a logic set? How do you name logic sets? – Meaningful to users – Accurate and unambiguous – Not too long Reporting logic on one page, actions on another? – Reporting logic inextricably linked to reporting action 33 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

34 Detailed diagnostic criteria vs. simple triggers At least one of the following: prolonged productive cough, night sweats, fever, weight loss, or [other Not otherwise specified clinical abnormality- such as wound that won't heal or enlarged pericardium, etc] AND other diagnoses have already been ruled out. Cases or suspected cases of tuberculosis 34 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

35 Expression of lab results Lab test categories must be meaningful to public health rule authors – Not as granular as LOINC, but mappable Pertussis example – Isolation of Bordetella pertussis from a clinical specimen – Positive PCR for B. pertussis – IgM positive serology for B. pertussis – IgA positive serology for B. pertussis – DFA positive for B. pertussis 35 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

36 Expression of lab results What’s in the test and what’s in the result – Organism specific culture --- “Positive” Bordetella pertussis [Presence] in Nasopharynx by Organism specific culture -- Positive – Non-organism specific culture --- Organism identified Bacteria identified in Nasopharynx by Culture --- Bordetella pertussis 36 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

37 Sending info to EHRs Public health reporting is a clinical decision support problem (…when not fully automated) A variety of PHCR interaction patterns exist, including: – Create report and send (fully automated) – Create report and present for clinician approval – Create report and present additional questions ONC S&I Framework Structured Data Capture Initiative (SDC) 37 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

38 Providing machine-processable information to EHRs September 2012: no clear “best standard” Formal assessment by Lantana Consulting Group – Maturity, adoptability (HITSC) – Applicability, testability Reviewed 4 candidate standards – HL7 Health Quality Measures Format (HQMF) – HL7 Arden Syntax – HL7 Decision Support Service (DSS) – HL7 Infobutton “Based on the suitability analysis, we conclude that the HL7 Health Quality Measures Format (HQMF) standard best meets the specification requirements defined by the RCKMS project.” 38 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

39 HQMF for pertussis in SD Informaticists from the Public Health Data Standards Consortium (PHDSC) developed HQMF files – Pertussis reporting specifications from Colorado and San Diego county Easy – Authors – Clinical concepts – Simple conditional logic – Reporting methods – Links 39 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

40 HQMF for pertussis in SD Difficult – Public health concepts Vocabulary for types of reporters Timeframe for reporting – Required reporting period specified in rule but….reporters should still report even If outside timeframe Structured representation of age – Value sets that contain codes from different coding systems (e.g., diagnoses/problems in SNOMED or ICD- 10-CM) – Complex conditional logic 40 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

41 Healthy Decisions (HeD) ONC S&I Framework Initiative Scope: To identify, define and harmonize standards that facilitate the emergence of systems and services whereby shareable CDS interventions can be implemented via: – Standards to structure medical knowledge in a shareable and executable format for use in CDS, and – Standards that define how a system can interact with and utilize an electronic interface that provides helpful, actionable clinical guidance 41 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

42 HeD HL7 IG HL7 Implementation Guide: Clinical Decision Support Knowledge Artifact Implementation Guide, Release 1 – HL7 DSTU Ballot – January 2013 Review and disposition of comments completed Standard to be used in pilots 42 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

43 RCKMS and HeD Have formally committed to pilot project EHR partner being identified, in partnership with HeD Starting with San Diego pertussis Aziz Boxwala (HeD SME) converting RCKMS information into HeD format – Some challenges persist 43 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

44 Specifying the PH report CDA for PHCR – balloted by HL Extended and updated in PHDSC pilot project Standards & Interoperability (S&I) Framework Public Health Reporting Initiative (PHRI) – Guide to Constrain the CDA R2 Specification to support PH Reporting with two Examples of Document Level Constraints (Communicable Disease and Adverse Events) 4/24/ Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

45 Knowledge Representation Subgroup Co-Leads: Karen Eilbeck and Catherine Staes -- University of Utah Facilitator: Sundak Ganesan – CDC Members: Anna Orlova – John Hopkins School of PH Arun Srinivasan - CDC Austin Kreisler - CDC Cecil Lynch – Accenture Cindy Vinion - Northrup Grumman Jeff Kriseman - CDC Jerry Sable – The St. Johns Group Julie Lipstein – L3 STRATIS Nikolay Lipskiy - CDC Scott Keller – Northrup Grumman Senthil Nachimuthu – 3M Health Information Systems Sheila Abner - CDC Sunanda (Shu) McGarvey – Northrup Grumman Progress towards RCKMS CSTE 2013 Annual Meeting 456/11/2013

46 KR Subgroup Objectives Determine which use cases would benefit from a formal knowledge representation Identify the domains of knowledge required by RCKMS to fulfill the use cases – Classify where data is hierarchical or has complex relationships (e.g., jurisdictions, reportable conditions [events]) – Identify existing knowledge representations that may be used by RCKMS – Describe knowledge internal to the reporting domain Analyze benefits of a formal representation and RCKMS functionality 46 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

47 RCKMS boundaries Public health domain-specific knowledge – Reportable conditions – Reporting criteria – Reporting actions – Jurisdictional rules Other knowledge – Diseases/health conditions Manifestations Diagnostic criteria Taxonomy Etiology Treatment – Anatomy – Microorganism taxonomy RCKMSnot-RCKMS 47 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

48 Ontological conundra Diagram and describe relationships among these: Dengue hemorrhagic fever Dengue fever Arboviral disease Viral hemorrhagic fever Dengue shock syndrome Varying levels of granularity – SRCA bane – “implicitly reportable” Condition and organism names evolve – Novel coronavirus –> MERS CoV 48 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

49 Next steps Secure funding to continue work Demo existing products to stakeholder organizations Continue pilot with HeD Build and test authoring framework Work with public health partners to build a national governance structure Develop plan for capturing information or all jurisdictions 49 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

50 Authoring framework Authorized users in public health jurisdictions require an authoring framework to specify: – The conditions that are reportable to them and how quickly they should be reported. – The criteria (e.g., lab, clinical, epidemiological) to be assessed in determining if the report qualifies to be sent to public health. – Where the report should be sent within the jurisdiction and the contact information for the receiving public health agency. – A statement of the actual regulatory or legal requirement for reporting and links to regulatory documents and other information related to reporting. – The information to be included in a report, and the format to use, including standards. 50 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

51 Authoring requirements Collaborative workflow management – Reporting requirements lifecycle Unambiguous representation of attribution and ownership for jurisdictional data – “Chain of custody” NEDSS snapshots – What was reportable where and when 51 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

52 Bottom line RCKMS is making good progress Lots of hard work remains Participation of many talented folks is wonderful Total immersion in national standards efforts is heartening Consignment of PHCR to Meaningful Use’s “future” is discouraging 52 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

53 Acknowledgements Too many to mention… Steering committee and subgroups Laura Conn My co-authors: Laura, Catherine, Shu Above all…the fabulous team of project managers, analysts and developers who have made RCKMS happen…. 53 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

54 The core team Brandon Mitchell Catherine Staes Cindy Vinion Duane Jones Eddie Reyes Gidado Immanuel Julie Lipstein Karen Chung Kimberly Carson Randheer Gehlot Scott Keller Shu McGarvey Tariq Ali THANK YOU! 54 Progress towards RCKMS CSTE 2013 Annual Meeting 6/11/2013

55 Questions? (…and thank you all!)


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