Evolving standards in public health case reporting Session plan Harmonizing Content of Public Health Surveillance Systems Lessons Learned from the ONC Standards and Interoperability SampI Public Health Reporting Initiative PHRI ID: 694794
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Slide1
Making really good sausage
Evolving standards in public health case reportingSlide2
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WITHDRAWN
WITHDRAWNSlide3
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 MeetingSlide4
Where we were this time last year
CSTE-CDC ELR Taskforce Standards Workgroup
RCMT a startNeed moreFunded RCKMS project had just started May 2012
be careful what you wish for…
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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.
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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 2009.
Make explicit the variation in reporting requirements that now exists, enabling review by stakeholders with the goal of reducing variation determined to be unnecessary.
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What’s happened since then
Implementation of first phase of RCKMS
Initially funded through 1/2013Additional funding extends work through 6/2013Steering committee, working groups
Stakeholder representation
PH
organizations (CDC, CSTE, NACCHO, APHL)
Epidemiologists, laboratorians, informaticistsVendors, healthcare provider organizations
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RCKMS Steering Committee
Co-leads
Rita Altamore-Washington State DOHLaura Conn-CDC/PHSIPOMembersShandy Dearth-Marion County HD/NACCHO
Karen Eilbeck-University of Utah
Shaun Grannis-Regenstrief Institute
Janet Hamilton
- Florida DOH /CSTE
Leslie Ann Helmus-Virginia DOHRuth Ann Jajosky-CDC/PHSIPO
Riki Merrick-iConnect Consulting/APHLNinad Mishra-CDC/PHITPO
Catherine Staes-University of UtahCDC Project SponsorsBob Pinner-CDC/NCEZIDKathy Gallagher-CDC/PHSIPO
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RCKMS Subgroup Structure
Representation from
the very diverse set of stakeholder groupsMembers provide expertise and review and approve deliverablesRequirements
Sunanda McGarvey / Julie Lipstein
Jurisdictional Validation for Pilot Content
Catherine Staes / Rita Altamore
Healthcare/ Vendor Partner Validation for Pilot
Brian Labus / Shu McGarveyKnowledge Representation
Karen Eilbeck/ Catherine Staes; facilitator - Sundak Ganesan GovernanceRita Altamore / Laura Conn
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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 soDemonstrate capability
Pilot project
Information PH
clinical settingClinical setting
PH pilot project already underway
PHDSC Clinical Document Architecture (CDA) for Public Health
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RCKMS pilot: reportable conditions
Pertussis
Part of CDA for PH pilot projectTuberculosisPart of CDA for PH pilot projectBlood lead level
Non-infectious condition
Reportable throughout the US
Known variation in reporting requirements
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RCKMS pilot: jurisdictions
Colorado
DelawareCDA 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)UtahWashington State
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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 theseContact information about the public health
entity thatauthored the content
authenticated the contentis responsible for the rules reflected by the content
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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 residenceLocation where clinical care was delivered
Location of the laboratory.
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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
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Information gathered (4)
Methods for PH to receive a report
Phone and fax numbersURLs for reporting formsContact
information to set up ELR
Links to additional information
Jurisdictional reporting laws and
rulesCSTE position statements
Clinical and other guidance
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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)
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Accomplishments
Data collection and persistenceWeb site development
Standardized outputHuman readableMachine processableEvaluation by a diverse set of users
Vendor
engagement
Subscriptions/notifications
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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.
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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.
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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.
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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.
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RCKMS
p
ilot application – criteria set 1
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RCKMS
p
ilot application – criteria set 2
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RCKMS
p
ilot application – test value set
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RCKMS
p
ilot application – links and references
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Challenges
Collecting the information
Case reporting -- not case classification / case notificationRepresenting the information in data structures
Complexity
Criteria statements not designed for computing
Variation
Representing the information for human readersRepresenting the information for EHRs
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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 discussionBottom line: Collective yawn
RCKMS staff
team got migraines
Even
with only 7 pilot jurisdictions, huge variation
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Variation
Relevant Jurisdiction
Blood lead level
Patient’s Age
Reporting
timeframe
Utah
≥10mg/dL
Any
60 days
< 10mg/dL
Any
No action – not reportable
Colorado
≥10mg/dL
≤18 years
7 working days
< 10mg/dL
≤ 18 years
30 days
≥ 25mg/dL
> 18 years
30 days
< 25mg/dL
> 18 years
No action – not reportable
Washington
≥ 10mg/dL
≤15 years
2 working days
< 10mg/dL
≤ 15 years
1 month
≥25mg/dL
Any
2 working days
< 25mg/dL
> 15 years
1 month
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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 readerHard (impossible?) to render in computable form
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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.
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CSTE Table VI-B for pertussis
Criterion
Reporting
Clinical Evidence
Cough (any duration)
N
Cough > 2 weeks duration
N
Inspiratory whoop
N
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. pertussis
S
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.)
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Drawing the line
What makes a logic set a logic set?
How do you name logic sets?Meaningful to usersAccurate and unambiguousNot too longReporting logic on one
page, actions on another
?
Reporting logic inextricably linked to reporting
action
X
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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
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Expression of lab results
Lab test categories must be meaningful to public health rule authors
Not as granular as LOINC, but mappablePertussis 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
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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 -- PositiveNon-organism specific culture --- Organism identified
Bacteria identified in Nasopharynx by Culture
---
Bordetella pertussis
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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 approvalCreate report and present additional questions
ONC S&I Framework Structured Data Capture Initiative (SDC)
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Providing machine-processable information to EHRs
September 2012
: no clear “best standard”Formal assessment by Lantana Consulting GroupMaturity, 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
.”
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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
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HQMF for pertussis in SD
Difficult
Public health conceptsVocabulary for types of reportersTimeframe for reportingRequired 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
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Healthy Decisions (HeD)
ONC S&I Framework Initiative
http://wiki.siframework.org/Health+eDecisions+HomepageScope: 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
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HeD HL7 IG
HL7 Implementation Guide: Clinical Decision Support Knowledge Artifact Implementation Guide, Release 1
HL7 DSTU Ballot – January 2013Review and disposition of comments completedStandard to be used in pilots
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RCKMS and HeD
Have formally committed to pilot projectEHR partner being identified, in partnership with HeD
Starting with San Diego pertussisAziz Boxwala (HeD SME) converting RCKMS information into HeD formatSome challenges persist
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Specifying the PH report
CDA for PHCR – balloted by HL7 2009
Extended and updated in PHDSC pilot projectStandards & 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) 4/24/2013
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Knowledge
Representation Subgroup
Co-Leads: Karen Eilbeck and Catherine Staes -- University
of Utah
Facilitator:
Sundak
Ganesan – CDCMembers:
Anna Orlova – John Hopkins School of PHArun Srinivasan - CDCAustin Kreisler - CDCCecil Lynch
– Accenture
Cindy Vinion - Northrup GrummanJeff Kriseman - CDCJerry Sable – The St. Johns GroupJulie Lipstein – L3 STRATIS
Nikolay Lipskiy - CDCScott Keller – Northrup GrummanSenthil Nachimuthu – 3M Health Information SystemsSheila Abner - CDCSunanda (Shu) McGarvey – Northrup Grumman
Progress towards RCKMS CSTE 2013 Annual Meeting
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KR Subgroup
Objectives
Determine which use cases would benefit from a formal knowledge representationIdentify the domains of knowledge required by RCKMS to fulfill the use casesClassify 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
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RCKMS boundaries
Public health domain-specific knowledge
Reportable conditionsReporting criteriaReporting actionsJurisdictional rules
Other knowledge
Diseases/health conditions
Manifestations
Diagnostic criteria
TaxonomyEtiology
TreatmentAnatomyMicroorganism taxonomy
RCKMS
n
ot-RCKMS
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Ontological conundra
Diagram and describe
relationships among these:Dengue hemorrhagic feverDengue feverArboviral disease
Viral hemorrhagic fever
Dengue shock syndrome
Varying levels of
granularity SRCA bane – “implicitly reportable”
Condition and organism names evolveNovel coronavirus –> MERS CoV
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Next steps
Secure funding to continue work
Demo existing products to stakeholder organizationsContinue pilot with HeDBuild and test authoring frameworkWork with public health partners to build a national governance structureDevelop plan for capturing information or all jurisdictions
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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.
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Authoring requirements
Collaborative workflow managementReporting requirements lifecycle
Unambiguous representation of attribution and ownership for jurisdictional data“Chain of custody”NEDSS snapshotsWhat was reportable where and when
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Bottom line
RCKMS is making good progress
Lots of hard work remainsParticipation of many talentedfolks is wonderfulTotal immersion in national
standards efforts is heartening
Consignment
of PHCR to
Meaningful Use’s “future” is discouraging
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Acknowledgements
Too many to mention…Steering committee and subgroups
Laura ConnMy co-authors: Laura, Catherine, ShuAbove all…the fabulous team of
project managers, analysts
and developers who have made
RCKMS happen….
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The core team
Brandon
Mitchell Catherine Staes Cindy Vinion
Duane
Jones
Eddie Reyes
Gidado ImmanuelJulie Lipstein
Karen
Chung Kimberly Carson Randheer Gehlot Scott Keller Shu McGarvey
Tariq Ali
THANK YOU
!
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Questions?
(…and thank you
all!)