RCKMS

Report
Making really good sausage
Evolving standards in public health
case reporting
Session plan
• Harmonizing Content of Public Health Surveillance
Systems: Lessons Learned from the ONC Standards and
Interoperability (S&I) Public Health Reporting Initiative
(PHRI) WITHDRAWN
• 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Architecture (CDA) WITHDRAWN
6/11/2013
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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
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…
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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 1/2013
– 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
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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
6/11/2013
– Leslie Ann Helmus-Virginia
DOH
– Ruth Ann JajoskyCDC/PHSIPO
– Riki Merrick-iConnect
Consulting/APHL
– Ninad Mishra-CDC/PHITPO
– Catherine Staes-University
of Utah
• CDC Project Sponsors
– Bob Pinner-CDC/NCEZID
– Kathy GallagherCDC/PHSIPO
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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
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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 so
• Demonstrate capability
– Pilot project
– Information PH  clinical setting
• Clinical 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 project
• Tuberculosis
– Part of CDA for PH pilot project
• Blood lead level
– Non-infectious condition
– Reportable throughout the US
– Known variation in reporting requirements
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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
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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 these
– Contact information about the public health entity that
• authored the content
• authenticated the content
• is 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 residence
• Location 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 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
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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 persistence
• Web site development
• Standardized output
– Human readable
– Machine processable
• Evaluation 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 pilot application – criteria set 1
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RCKMS pilot application – criteria set 2
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RCKMS pilot application – test value set
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RCKMS pilot application – links and references
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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
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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 discussion
– Bottom line:
• Collective yawn
• RCKMS staff team got migraines
– Even with only 7 pilot jurisdictions, huge variation
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Variation
Relevant
Blood lead
Jurisdiction level
≥10mg/dL
Utah
< 10mg/dL
Colorado
Any
Reporting timeframe
60 days
No action – not reportable
≥10mg/dL
< 10mg/dL
≥ 25mg/dL
≤18 years 7 working days
≤ 18 years 30 days
> 18 years 30 days
< 25mg/dL
> 18 years No action – not reportable
≥ 10mg/dL
< 10mg/dL
Washington
≥25mg/dL
< 25mg/dL
6/11/2013
Patient’s
Age
Any
≤15 years
≤ 15 years
Any
> 15 years
2 working days
1 month
2 working days
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 reader
• Hard (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
Clinical Evidence
Cough (any duration)
Cough > 2 weeks duration
Inspiratory whoop
Healthcare record contains a diagnosis of
pertussis
Reporting
N
N
N
S
Death certificate lists pertussis as a cause
of death or a significant condition
contributing to death
Laboratory Evidence
Isolation of Bordetella pertussis from a
clinical specimen
Positive PCR for B. pertussis
Epidemiologic Evidence
Contact with a laboratory-confirmed
pertussis case
Member of a defined risk group during an
outbreak
6/11/2013
S
S
S
O
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 users
– Accurate and unambiguous
– Not too long
• Reporting logic on one page, actions on
another?
– Reporting logic inextricably linked to reporting
action
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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 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
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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 -- Positive
– Non-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 approval
– Create 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 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.”
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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
–
–
–
–
–
6/11/2013
Authors
Clinical concepts
Simple conditional logic
Reporting methods
Links
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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 ICD10-CM)
– Complex conditional logic
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Healthy Decisions (HeD)
• ONC S&I Framework Initiative
http://wiki.siframework.org/Health+eDecisions+Homepage
• 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
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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
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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
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Specifying the PH report
• CDA for PHCR – balloted by HL7 2009
• 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) 4/24/2013
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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
6/11/2013
• 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
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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
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RCKMS boundaries
• Public health
domain-specific
knowledge
• Other knowledge
– Diseases/health conditions
– Reportable
conditions
– Reporting criteria
– Reporting actions
– Jurisdictional
rules
RCKMS
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•
•
•
•
•
Manifestations
Diagnostic criteria
Taxonomy
Etiology
Treatment
– Anatomy
– Microorganism taxonomy
not-RCKMS
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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
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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
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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 management
– Reporting requirements lifecycle
• Unambiguous representation of attribution
and ownership for jurisdictional data
– “Chain of custody”
• NEDSS snapshots
– What was reportable where and when
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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
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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….
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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!
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(…and thank you all!)
Questions?

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